<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0034-7418</journal-id>
<journal-title><![CDATA[Revista Colombiana de Ciencias Químico - Farmacéuticas]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. colomb. cienc. quim. farm.]]></abbrev-journal-title>
<issn>0034-7418</issn>
<publisher>
<publisher-name><![CDATA[Departamento de Farmácia, Facultad de Ciencias, Universidade Nacional da Colombia]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0034-74182022000100041</article-id>
<article-id pub-id-type="doi">10.15446/rcciquifa.v51n1.94772</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[In vitro transdermal drug permeation tests: a regulatory scenario evaluation]]></article-title>
<article-title xml:lang="es"><![CDATA[Pruebas de permeación transdérmica de fármacos in vitro: una evaluación del escenario regulatorio]]></article-title>
<article-title xml:lang="pt"><![CDATA[Testes de permeação transdérmica de drogas in vitro:uma avaliação do cenário regulatório]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Engelhardt]]></surname>
<given-names><![CDATA[Renata Lourenço]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[da Silva]]></surname>
<given-names><![CDATA[Thalita Martins]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[do Carmo]]></surname>
<given-names><![CDATA[Flávia Almada]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Antunes Rocha]]></surname>
<given-names><![CDATA[Helvécio Vinícius]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto de Tecnologia em Fármacos  ]]></institution>
<addr-line><![CDATA[Rio de Janeiro ]]></addr-line>
<country>Brasil</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Laboratório de Micro e Nanotecnologia  ]]></institution>
<addr-line><![CDATA[Rio de Janeiro RJ]]></addr-line>
<country>Brasil</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Universidade Federal do Rio de Janeiro  ]]></institution>
<addr-line><![CDATA[ RJ]]></addr-line>
<country>Brazil</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<volume>51</volume>
<numero>1</numero>
<fpage>41</fpage>
<lpage>67</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0034-74182022000100041&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0034-74182022000100041&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0034-74182022000100041&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[SUMMARY  Introduction: The Transdermal Drug Delivery Systems (TDDS) could circumvent the inconveniences of oral administration, increasing treatment adhesion. Meanwhile, despite being highly widespread systems, there are discrepancies between the performance and quality control methodologies recommended by the leading regulatory agencies, which is an issue for the pharmaceutical industry.  Aim: To identify and to compare the requirements for TDDS regulatory approval by important agencies, focusing on the in vitro release and drug permeation studies, which are crucial tests for the evaluation of safety, efficacy, and performance of these systems.  Methods: The documents that regulate the scope of TDDS in FDA, EMA and Anvisa were analyze, as well as the contributions of OECD. In addition, an approaching regarding the pharmacopeial requirements was made regarding USA, Europe, and Brazil.  Results and conclusion: Concerning the regulatory approval aspects, the FDA is reviewing its documents because the current guidance is not specific to transdermal systems. On the other hand, the EMA presents a unique guideline that includes specific requirements for TDDS. The USA and the European Pharmacopoeias have specific mentions to performance and quality control of TDDS, while the Brazilian Pharmacopoeia does not mention this dosage form. Recently, Anvisa published a guide, which helps Brazilian manufacturers concerning the tests required for the regulatory approval of a new TDDS. The launch of this standardized national statute associated with the use of a validated in vitro release and permeation tests represents a remarkable breakthrough regarding TDDS.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción: los sistemas de administración de fármacos transdérmicos (TDDS) podrían sortear los inconvenientes de la administración por vía oral, aumentando la adherencia al tratamiento. Mientras tanto, a pesar de ser sistemas muy extendidos, existen discrepancias entre las metodologías de desempeño y control de calidad recomendadas por las principales agencias reguladoras, lo cual es un problema para la industria farmacéutica.  Objetivo:  identificar y comparar los requisitos para la aprobación regulatoria de TDDS por parte de las principales agencias reguladoras, enfocándose en los estudios de liberación in vitro y premiación de fármacos.  Métodos: se analizaron los documentos que regulan el alcance de la TDDS en la FDA, EMA y Anvisa, así como los aportes de la OCDE. Además, se realizó un planteamiento sobre los requisitos de las farmacopeas de los Estados Unidos, Europa y Brasil.  Resultados y conclusión: la FDA está revisando los aspectos de aprobación regulatoria porque la guía actual no es específica para los sistemas transdérmicos. Por otro lado, la EMA presenta una guía única que incluye requisitos específicos para TDDS. Las farmacopeas de los Estados Unidos e Europa tienen menciones específicas al rendimiento y control de calidad de TDDS, mientras que la Farmacopea brasileña no menciona esta forma de dosificación. Recientemente, Anvisa publicó una guía que ayuda a los fabricantes brasileños en cuanto a las pruebas requeridas para la aprobación regulatoria de un nuevo TDDS. El lanzamiento de este estatuto nacional estandarizado asociado con el uso de pruebas validadas de liberación y premiación in vitro representa un avance notable con respecto a TDDS.]]></p></abstract>
<abstract abstract-type="short" xml:lang="pt"><p><![CDATA[RESUMO  Introdução: os sistemas de liberação transdérmica (SLT) são capazes de contornar as desvantagens da administração oral de medicamentos, aumentando a adesão ao tratamento. Entretanto, apesar de serem sistemas difundidos, existem discrepâncias entre as metodologias de desempenho e controle de qualidade recomendadas pelas agências regulatórias, dificultando o desenvolvimento destes pela indústria farmacêutica.  Objetivo: identificar e comparar os requisitos para aprovação regulatória de SLT por importantes agências regulatórias, com foco nos estudos de liberação e permeação de fármacos in vitro, testes fundamentais para avaliação da segurança, eficácia e desempenho desses sistemas.  Métodos: foram analisados os documentos que regulam o escopo dos SLT publicados pela FDA, EMA e Anvisa e as contribuições da OCDE. Além disso, foi realizada a abordagem sobre os requisitos farmacopeicos nos Estados Unidos, Europa e Brasil.  Resultados e conclusão: FDA está revisando os aspectos de aprovação regulatória, pois os documentos atuais não são específicos para os SLT. Em contraponto, a EMA apresenta uma diretriz única que inclui requisitos específicos para estes sistemas. Em relação às farmacopeias, enquanto EUA e Europa apresentam recomendações específicas para desempenho e controle de qualidade dos SLT, a Farmacopeia brasileira não menciona esta forma farmacêutica. Recentemente, a Anvisa publicou um guia com os testes necessários para o registro destes sistemas. O lançamento de tal publicação, associado a ensaios devidamente validados representam um avanço notável no escopo regulatório dos SLT.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Transdermal patch]]></kwd>
<kwd lng="en"><![CDATA[regulatory frameworks]]></kwd>
<kwd lng="en"><![CDATA[medical device legislation]]></kwd>
<kwd lng="en"><![CDATA[cutaneous drug administration]]></kwd>
<kwd lng="es"><![CDATA[parche transdérmico]]></kwd>
<kwd lng="es"><![CDATA[marcos reguladores]]></kwd>
<kwd lng="es"><![CDATA[legislación de dispositivos médicos]]></kwd>
<kwd lng="es"><![CDATA[administración cutánea]]></kwd>
<kwd lng="pt"><![CDATA[adesivo transdérmico]]></kwd>
<kwd lng="pt"><![CDATA[marcos regulatórios]]></kwd>
<kwd lng="pt"><![CDATA[legislação de dispositivos médicos]]></kwd>
<kwd lng="pt"><![CDATA[administração cutânea]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Silva]]></surname>
<given-names><![CDATA[J.A.]]></given-names>
</name>
<name>
<surname><![CDATA[Apolinário]]></surname>
<given-names><![CDATA[A.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Souza]]></surname>
<given-names><![CDATA[M.S.R.]]></given-names>
</name>
<name>
<surname><![CDATA[Damasceno]]></surname>
<given-names><![CDATA[B.P.G.L.]]></given-names>
</name>
<name>
<surname><![CDATA[Medeiros]]></surname>
<given-names><![CDATA[A.C.D.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Administração cutânea de fármacos: desafios e estratégias para o desenvolvimento de formulações transdérmicas]]></article-title>
<source><![CDATA[Revista de Ciências Farmacêuticas Básica e Aplicada]]></source>
<year>2010</year>
<volume>31</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>125-31</page-range></nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="">
<collab>Brasil</collab>
<source><![CDATA[Ministério da Saúde. Agência Nacional de Vigilância Sanitária, Boas Práticas Regulatórias: guia para o programa de melhoria do processo de regulamentação da Anvisa]]></source>
<year>2008</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B3">
<label>3</label><nlm-citation citation-type="book">
<collab>Brasil</collab>
<source><![CDATA[Ministério da Saúde. Agência Nacional de Vigilância Sanitária]]></source>
<year>2019</year>
<volume>1</volume>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
<publisher-name><![CDATA[Farmacopeia Brasileira]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="confpro">
<collab>Council of Europe</collab>
<source><![CDATA[European Directorate for the Quality of Medicines and Health Care]]></source>
<year>2020</year>
<conf-name><![CDATA[ European Pharmacopoeia, Monograph 1011: Transdermal Patches, 10th]]></conf-name>
<conf-loc>Strasbourg </conf-loc>
</nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="">
<collab>The United States Pharmacopeia</collab>
<source><![CDATA[General Chapter 3. Topical and Transdermal Drug Products: Product Quality Tests]]></source>
<year>2021</year>
<edition>44nd</edition>
<publisher-loc><![CDATA[Rockville ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Bronaugh]]></surname>
<given-names><![CDATA[R.L.]]></given-names>
</name>
<name>
<surname><![CDATA[Hood]]></surname>
<given-names><![CDATA[H.L.]]></given-names>
</name>
<name>
<surname><![CDATA[Kraeling]]></surname>
<given-names><![CDATA[M.E.K.]]></given-names>
</name>
<name>
<surname><![CDATA[Yourick]]></surname>
<given-names><![CDATA[J.J.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Determination of percutaneous absorption by in vitro techniques]]></article-title>
<source><![CDATA[Journal of Toxicology: Cutaneous and Ocular Toxicology]]></source>
<year>2001</year>
<volume>20</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>423-7</page-range></nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="confpro">
<collab>Council of Europe</collab>
<source><![CDATA[European Directorate for the Quality of Medicines and Health Care]]></source>
<year>2020</year>
<conf-name><![CDATA[ Chapter 2.9.4: Dissolution tests for transdermal patches, 10th]]></conf-name>
<conf-loc>Strasbourg </conf-loc>
</nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="">
<collab>The United States Pharmacopeia</collab>
<source><![CDATA[General Chapter 724 Drug Release]]></source>
<year>2020</year>
<edition>42nd</edition>
<publisher-loc><![CDATA[Rockville ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Zsikó]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Csányi]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Kovács]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Budai-Szücs]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Gácsi]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Berkó]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Methods to evaluate skin penetration in vitro]]></article-title>
<source><![CDATA[Scientia Pharmaceutica]]></source>
<year>2019</year>
<volume>87</volume>
<numero>19</numero>
<issue>19</issue>
</nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Orazio]]></surname>
<given-names><![CDATA[J.L.]]></given-names>
</name>
<name>
<surname><![CDATA[Fischel]]></surname>
<given-names><![CDATA[J.A.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Recurrent respiratory depression associated with fentanyl transdermal patch gel reservoir ingestion]]></article-title>
<source><![CDATA[The Journal of Emergency Medicine]]></source>
<year>2012</year>
<volume>45</volume>
<numero>5</numero>
<issue>5</issue>
<page-range>543-8</page-range></nlm-citation>
</ref>
<ref id="B11">
<label>11</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Wokovich]]></surname>
<given-names><![CDATA[A.M.]]></given-names>
</name>
<name>
<surname><![CDATA[Prodduturi]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Doub]]></surname>
<given-names><![CDATA[W.H.]]></given-names>
</name>
<name>
<surname><![CDATA[Hussain]]></surname>
<given-names><![CDATA[A.S.]]></given-names>
</name>
<name>
<surname><![CDATA[Buhse]]></surname>
<given-names><![CDATA[L.F.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy and quality atribute]]></article-title>
<source><![CDATA[European Journal oh Pharmaceutics and Biopharmaceutics]]></source>
<year>2006</year>
<volume>64</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>1-8</page-range></nlm-citation>
</ref>
<ref id="B12">
<label>12</label><nlm-citation citation-type="book">
<collab>World Health Organization</collab>
<source><![CDATA[WHO Pharmaceuticals Newsletter]]></source>
<year>2005</year>
<volume>3</volume>
<page-range>1-17</page-range><publisher-name><![CDATA[WHO]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B13">
<label>13</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Oliveira]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
<name>
<surname><![CDATA[Hadgraft]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Lane]]></surname>
<given-names><![CDATA[M.E.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Toxicological implications of the delivery of fentanyl from gel extracted from a comercial transdermal reservoir patch]]></article-title>
<source><![CDATA[Toxicology in vitro]]></source>
<year>2012</year>
<volume>26</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>645-8</page-range></nlm-citation>
</ref>
<ref id="B14">
<label>14</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Patel]]></surname>
<given-names><![CDATA[D.]]></given-names>
</name>
<name>
<surname><![CDATA[Chaudhary]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Parmar]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Bhura]]></surname>
<given-names><![CDATA[N.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Transdermal drug delivery system: A review]]></article-title>
<source><![CDATA[The Pharma Innovation]]></source>
<year>2012</year>
<volume>1</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>66-75</page-range></nlm-citation>
</ref>
<ref id="B15">
<label>15</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[FDA Drug Safety Comunication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD]]></source>
<year>2015</year>
<publisher-loc><![CDATA[Rockville, USA ]]></publisher-loc>
<publisher-name><![CDATA[Center for Drug Evaluation and Research (CDER)]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B16">
<label>16</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Guidance for Industry. Nonsterile semisolid dosage forms. Scale-up and post approval changes: chemistry, manufacturing, and controls; in vitro release testing and in vivo bioequivalence documentation]]></source>
<year>1997</year>
<publisher-loc><![CDATA[Rockville, USA ]]></publisher-loc>
<publisher-name><![CDATA[Drug Evaluation and Research (CDER), US Department of Health and Human Services]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B17">
<label>17</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Draft Guidance for Industry: Transdermal and topical delivery systems, product development and quality considerations]]></source>
<year>2019</year>
<publisher-loc><![CDATA[Rockville, USA ]]></publisher-loc>
<publisher-name><![CDATA[Center for Drug Evaluation and Research (CDER), US Department of Health and Human Services]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B18">
<label>18</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ghosh]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Milewski]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Paudel]]></surname>
<given-names><![CDATA[K.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[In vitro/in vivo correlations in transdermal product development]]></article-title>
<source><![CDATA[Therapeutic Delivery]]></source>
<year>2015</year>
<volume>6</volume>
<numero>9</numero>
<issue>9</issue>
<page-range>1117-24</page-range></nlm-citation>
</ref>
<ref id="B19">
<label>19</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Jiang]]></surname>
<given-names><![CDATA[Q.D.]]></given-names>
</name>
<name>
<surname><![CDATA[Wu]]></surname>
<given-names><![CDATA[Y.M.]]></given-names>
</name>
<name>
<surname><![CDATA[Zhang]]></surname>
<given-names><![CDATA[H.]]></given-names>
</name>
<name>
<surname><![CDATA[Liu]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Chen]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Duan]]></surname>
<given-names><![CDATA[J.A.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Evaluation of pharmacokinetics and in vitro/in vivo correlation of ibuprofen with essential oils as penetration enhancer following transdermal administration]]></article-title>
<source><![CDATA[China Journal of Chinese Materia Medica, (Zhongguo Zhong Yao Za Zhi)]]></source>
<year>2016</year>
<volume>41</volume>
<numero>23</numero>
<issue>23</issue>
<page-range>4362-7</page-range></nlm-citation>
</ref>
<ref id="B20">
<label>20</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Shin]]></surname>
<given-names><![CDATA[S.H.]]></given-names>
</name>
<name>
<surname><![CDATA[Thomas]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Raney]]></surname>
<given-names><![CDATA[S.G.]]></given-names>
</name>
<name>
<surname><![CDATA[Ghosh]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Hammell]]></surname>
<given-names><![CDATA[D.C.]]></given-names>
</name>
<name>
<surname><![CDATA[El-Kamary]]></surname>
<given-names><![CDATA[S.S.]]></given-names>
</name>
<name>
<surname><![CDATA[Chen]]></surname>
<given-names><![CDATA[W.H.]]></given-names>
</name>
<name>
<surname><![CDATA[Billington]]></surname>
<given-names><![CDATA[M.M.]]></given-names>
</name>
<name>
<surname><![CDATA[Hassan]]></surname>
<given-names><![CDATA[H.E.]]></given-names>
</name>
<name>
<surname><![CDATA[Stinchcomb]]></surname>
<given-names><![CDATA[A.L.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[In vitro-in vivo correlations for nicotine transdermal delivery systems evaluated by both in vitro skin permeation (IVPT) and in vivo serum pharmacokinetics under the influence of transient heat application]]></article-title>
<source><![CDATA[Journal of Controlled Release]]></source>
<year>2018</year>
<volume>270</volume>
<page-range>76-88</page-range></nlm-citation>
</ref>
<ref id="B21">
<label>21</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Alonso]]></surname>
<given-names><![CDATA[C.]]></given-names>
</name>
<name>
<surname><![CDATA[Carrer]]></surname>
<given-names><![CDATA[V.]]></given-names>
</name>
<name>
<surname><![CDATA[Espinosa]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Zanuy]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Córdoba]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Vidal]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Domínguez]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Godessart]]></surname>
<given-names><![CDATA[N.]]></given-names>
</name>
<name>
<surname><![CDATA[Coderch]]></surname>
<given-names><![CDATA[L.]]></given-names>
</name>
<name>
<surname><![CDATA[Pont]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Prediction of the skin permeability of topical drugs using in silico and in vitro models]]></article-title>
<source><![CDATA[European Journal of Pharmaceutical Sciences]]></source>
<year>2019</year>
<volume>136</volume>
<page-range>104945</page-range></nlm-citation>
</ref>
<ref id="B22">
<label>22</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Guidance for Industry - Topical Dermatologic Corticosteroids: in vivo bioequivalence]]></source>
<year>1995</year>
<publisher-loc><![CDATA[Rockville, USA ]]></publisher-loc>
<publisher-name><![CDATA[Center for Drug Evaluation and Research (CDER)]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B23">
<label>23</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ritter]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Flower]]></surname>
<given-names><![CDATA[R.]]></given-names>
</name>
<name>
<surname><![CDATA[Henderson]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
<name>
<surname><![CDATA[Loke]]></surname>
<given-names><![CDATA[Y. K.]]></given-names>
</name>
<name>
<surname><![CDATA[MacEwan]]></surname>
<given-names><![CDATA[D.]]></given-names>
</name>
<name>
<surname><![CDATA[Rang]]></surname>
<given-names><![CDATA[H.]]></given-names>
</name>
</person-group>
<source><![CDATA[Rang &amp; Dale's Pharmacology]]></source>
<year>2019</year>
<publisher-loc><![CDATA[Oxford ]]></publisher-loc>
<publisher-name><![CDATA[Elsevier]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B24">
<label>24</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Andrade]]></surname>
<given-names><![CDATA[E.D.]]></given-names>
</name>
<name>
<surname><![CDATA[Groppo]]></surname>
<given-names><![CDATA[F.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Volpato]]></surname>
<given-names><![CDATA[M.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Rosalen]]></surname>
<given-names><![CDATA[P.L.]]></given-names>
</name>
<name>
<surname><![CDATA[Ranali]]></surname>
<given-names><![CDATA[JA.]]></given-names>
</name>
</person-group>
<source><![CDATA[A regulação de medicamentos no Brasil]]></source>
<year>2013</year>
<publisher-loc><![CDATA[Porto Alegre ]]></publisher-loc>
<publisher-name><![CDATA[Artmed]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B25">
<label>25</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Draft Guidance for Industry: Bioavailability studies in NDAs or INDs. General Considerations, Center for Drug Evaluation and Research (CDER)]]></source>
<year>2019</year>
<publisher-loc><![CDATA[USA ]]></publisher-loc>
<publisher-name><![CDATA[Rockville]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B26">
<label>26</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Skin Irritation and Sensitization Testing for Generic Transdermal Drug Products]]></source>
<year>1999</year>
<publisher-loc><![CDATA[Rockville, USA ]]></publisher-loc>
<publisher-name><![CDATA[Center for Drug Evaluation and Research (CDER)]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B27">
<label>27</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Draft Guidance for Industry: Assessing the irritation and sensitization potensial of transdermal and topical delivery systems for ANDAs]]></source>
<year>2018</year>
<publisher-loc><![CDATA[USA, Rockville ]]></publisher-loc>
<publisher-name><![CDATA[Center for Drug Evaluation and Research (CDER), Department of Health and Human Services]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B28">
<label>28</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Guidance for Industry: Residual Drug in Transdermal and Related Drug Delivery Systems]]></source>
<year>2011</year>
<publisher-loc><![CDATA[Rockville, USA ]]></publisher-loc>
<publisher-name><![CDATA[Center for Drug Evaluation and Research (CDER), Department of Health and Human Services]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B29">
<label>29</label><nlm-citation citation-type="journal">
<article-title xml:lang=""><![CDATA[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use]]></article-title>
<source><![CDATA[Pharmaceutical Development]]></source>
<year>2009</year>
<volume>Q8</volume>
<numero>R2</numero>
<issue>R2</issue>
</nlm-citation>
</ref>
<ref id="B30">
<label>30</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Jana]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Ali]]></surname>
<given-names><![CDATA[S.A.]]></given-names>
</name>
<name>
<surname><![CDATA[Nayak]]></surname>
<given-names><![CDATA[A.K.]]></given-names>
</name>
<name>
<surname><![CDATA[Sen]]></surname>
<given-names><![CDATA[K.K.]]></given-names>
</name>
<name>
<surname><![CDATA[Basu]]></surname>
<given-names><![CDATA[S.K.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Development of topical gel containing aceclofenaccrospovidone solid dispersion by "Quality by Design (QbD)" approach]]></article-title>
<source><![CDATA[Engineering Research and Design]]></source>
<year>2014</year>
<volume>92</volume>
<numero>11</numero>
<issue>11</issue>
<page-range>20952105</page-range></nlm-citation>
</ref>
<ref id="B31">
<label>31</label><nlm-citation citation-type="book">
<collab>Food and Drug Administration</collab>
<source><![CDATA[Draft Guidance for Industry: Asessing adhesion with transdermal and topical delivery systems for ANDAs, Center for Drug Evaluation and Research (CDER)]]></source>
<year>2018</year>
<publisher-loc><![CDATA[Rockville, USA ]]></publisher-loc>
<publisher-name><![CDATA[US Department of Health and Human Services]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B32">
<label>32</label><nlm-citation citation-type="book">
<collab>European Medicines Agency</collab>
<source><![CDATA[Commitee for Proprietary Medicinal Products]]></source>
<year>1999</year>
<publisher-loc><![CDATA[London ]]></publisher-loc>
<publisher-name><![CDATA[Notes for Guidance on Modified Release Oral and Transdermal Dosage Forms: Section II (Pharmacokinetic and Clinical Evaluation)]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B33">
<label>33</label><nlm-citation citation-type="book">
<collab>European Medicines Agency</collab>
<source><![CDATA[Commitee for Medicinal Products for Human Use (CHMP)]]></source>
<year>2014</year>
<publisher-loc><![CDATA[London ]]></publisher-loc>
<publisher-name><![CDATA[Guideline on quality of transdermal patches]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B34">
<label>34</label><nlm-citation citation-type="">
<collab>European Medicines Agency</collab>
<article-title xml:lang=""><![CDATA[Commitee for Medicinal Products for Human Use (CHMP)]]></article-title>
<source><![CDATA[Guideline on the pharmacokinetic and clinical evaluation of modified]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B35">
<label>35</label><nlm-citation citation-type="">
<collab>Organisation for Economic Cooperation and Development (OECD)</collab>
<article-title xml:lang=""><![CDATA[Guidance]]></article-title>
<source><![CDATA[Notes on Dermal Absorption]]></source>
<year>2011</year>
<numero>156</numero>
<issue>156</issue>
<publisher-loc><![CDATA[Paris ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B36">
<label>36</label><nlm-citation citation-type="">
<collab>Organisation for Economic Cooperation and Development (OECD)</collab>
<article-title xml:lang=""><![CDATA[Test N.° 428: Skin Absorption]]></article-title>
<source><![CDATA[Vitro Method]]></source>
<year>2021</year>
<publisher-loc><![CDATA[Paris ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B37">
<label>37</label><nlm-citation citation-type="">
<collab>Organisation for Economic Co-operation and Development (OECD)</collab>
<source><![CDATA[Skin Absorption: In Vivo Method]]></source>
<year>2004</year>
<numero>427</numero>
<issue>427</issue>
<publisher-loc><![CDATA[Paris ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B38">
<label>38</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Boonen]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Malysheva]]></surname>
<given-names><![CDATA[S.V.]]></given-names>
</name>
<name>
<surname><![CDATA[Taevernier]]></surname>
<given-names><![CDATA[L.]]></given-names>
</name>
<name>
<surname><![CDATA[Mavungu]]></surname>
<given-names><![CDATA[J.D. Di]]></given-names>
</name>
<name>
<surname><![CDATA[Saeger]]></surname>
<given-names><![CDATA[S. De]]></given-names>
</name>
<name>
<surname><![CDATA[Spiegeleer]]></surname>
<given-names><![CDATA[B. De]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Human skin penetration of selected model mycotoxins]]></article-title>
<source><![CDATA[Toxicology]]></source>
<year>2012</year>
<volume>301</volume>
<numero>1-3</numero>
<issue>1-3</issue>
<page-range>21-32</page-range></nlm-citation>
</ref>
<ref id="B39">
<label>39</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Escribano]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Calpena]]></surname>
<given-names><![CDATA[A.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Queralt]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Obach]]></surname>
<given-names><![CDATA[R.]]></given-names>
</name>
<name>
<surname><![CDATA[Doménech]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Assessment of diclofenac permeation with different formulations: anti-inflammatory study of a selected formula]]></article-title>
<source><![CDATA[European Journal of Pharmaceutical Sciences]]></source>
<year>2003</year>
<volume>19</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>203-10</page-range></nlm-citation>
</ref>
<ref id="B40">
<label>40</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Pineau]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Guillard]]></surname>
<given-names><![CDATA[O.]]></given-names>
</name>
<name>
<surname><![CDATA[Fauconneau]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Favreau]]></surname>
<given-names><![CDATA[F.]]></given-names>
</name>
<name>
<surname><![CDATA[Marty]]></surname>
<given-names><![CDATA[M.-H.]]></given-names>
</name>
<name>
<surname><![CDATA[Gaudin]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Vincent]]></surname>
<given-names><![CDATA[C. M.]]></given-names>
</name>
<name>
<surname><![CDATA[Marrauld]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Marty]]></surname>
<given-names><![CDATA[J.-P.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[In vitro study of percutaneous absorption of aluminum from antiperspirants through human skin in the FranzTM diffusion cell]]></article-title>
<source><![CDATA[Journal of Inorganic Biochemistry]]></source>
<year>2012</year>
<volume>110</volume>
<page-range>21-6</page-range></nlm-citation>
</ref>
<ref id="B41">
<label>41</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Schreiber]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Mahmoud]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Vuia]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Rübbelke]]></surname>
<given-names><![CDATA[M. K.]]></given-names>
</name>
<name>
<surname><![CDATA[Schmidt]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Schaller]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Kandárová]]></surname>
<given-names><![CDATA[H.]]></given-names>
</name>
<name>
<surname><![CDATA[Haberland]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Scháfer]]></surname>
<given-names><![CDATA[U.F.]]></given-names>
</name>
<name>
<surname><![CDATA[Bock]]></surname>
<given-names><![CDATA[U.]]></given-names>
</name>
<name>
<surname><![CDATA[Korting]]></surname>
<given-names><![CDATA[H.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Liebsch]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Scháfer-Korting]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Reconstructed epidermis versus human and animal skin in skin absorption studies]]></article-title>
<source><![CDATA[Toxicology in Vitro]]></source>
<year>2005</year>
<volume>19</volume>
<numero>6</numero>
<issue>6</issue>
<page-range>813-22</page-range></nlm-citation>
</ref>
<ref id="B42">
<label>42</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Sandt]]></surname>
<given-names><![CDATA[J.J.M. van de]]></given-names>
</name>
<name>
<surname><![CDATA[Burgsteden]]></surname>
<given-names><![CDATA[J.A. van]]></given-names>
</name>
<name>
<surname><![CDATA[Cage]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Carmichael]]></surname>
<given-names><![CDATA[P.L.]]></given-names>
</name>
<name>
<surname><![CDATA[Dick]]></surname>
<given-names><![CDATA[I.]]></given-names>
</name>
<name>
<surname><![CDATA[Kenyon]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Korinth]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
<name>
<surname><![CDATA[Larese]]></surname>
<given-names><![CDATA[F.]]></given-names>
</name>
<name>
<surname><![CDATA[Limasset]]></surname>
<given-names><![CDATA[J.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Maas]]></surname>
<given-names><![CDATA[W.J.M.]]></given-names>
</name>
<name>
<surname><![CDATA[Montomoli]]></surname>
<given-names><![CDATA[L.]]></given-names>
</name>
<name>
<surname><![CDATA[Nielsen]]></surname>
<given-names><![CDATA[J.B.]]></given-names>
</name>
<name>
<surname><![CDATA[Payan]]></surname>
<given-names><![CDATA[J.-P.]]></given-names>
</name>
<name>
<surname><![CDATA[Robinson]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Sartorelli]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Schaller]]></surname>
<given-names><![CDATA[K.H.]]></given-names>
</name>
<name>
<surname><![CDATA[Wilkinson]]></surname>
<given-names><![CDATA[S.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Williams]]></surname>
<given-names><![CDATA[F.M.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[In vitro predictions of skin absorption of caffeine, testosterone, and benzoic acid: a multi-centre comparison study]]></article-title>
<source><![CDATA[Regulatory Toxicology and Pharmacology]]></source>
<year>2004</year>
<volume>39</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>271-81</page-range></nlm-citation>
</ref>
<ref id="B43">
<label>43</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Williams]]></surname>
<given-names><![CDATA[F.M.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[In vitro studies, how good are they at replacing in vivo studies for measurement of skin absorption?]]></article-title>
<source><![CDATA[Environmental Toxicology and Pharmacology]]></source>
<year>2006</year>
<volume>21</volume>
<numero>2</numero>
<issue>2</issue>
<page-range>199-203</page-range></nlm-citation>
</ref>
<ref id="B44">
<label>44</label><nlm-citation citation-type="">
<collab>Organisation for Economic Cooperation and Development (OECD)</collab>
<source><![CDATA[Guidance Document for the Conduct of Skin Absorption Studies]]></source>
<year>2004</year>
<publisher-loc><![CDATA[Paris ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B45">
<label>45</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Buist]]></surname>
<given-names><![CDATA[H.]]></given-names>
</name>
<name>
<surname><![CDATA[Craig]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Dewhurst]]></surname>
<given-names><![CDATA[I.]]></given-names>
</name>
<name>
<surname><![CDATA[Hougaard-Bennekou]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Kneuer]]></surname>
<given-names><![CDATA[C.]]></given-names>
</name>
<name>
<surname><![CDATA[Machera]]></surname>
<given-names><![CDATA[K.]]></given-names>
</name>
<name>
<surname><![CDATA[Pieper]]></surname>
<given-names><![CDATA[C.]]></given-names>
</name>
<name>
<surname><![CDATA[Court-Marques]]></surname>
<given-names><![CDATA[D.]]></given-names>
</name>
<name>
<surname><![CDATA[Guillot]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
<name>
<surname><![CDATA[Ruffo]]></surname>
<given-names><![CDATA[F.]]></given-names>
</name>
<name>
<surname><![CDATA[Chiusolo]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Guidance on dermal absorption]]></article-title>
<source><![CDATA[EFSA Journal]]></source>
<year>2017</year>
<volume>15</volume>
<numero>6</numero>
<issue>6</issue>
</nlm-citation>
</ref>
<ref id="B46">
<label>46</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ross]]></surname>
<given-names><![CDATA[J.H.]]></given-names>
</name>
<name>
<surname><![CDATA[Reifenrath]]></surname>
<given-names><![CDATA[W.G.]]></given-names>
</name>
<name>
<surname><![CDATA[Driver]]></surname>
<given-names><![CDATA[J.H.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Estimation of the percutaneous absorption of permethrin in humans using the parallelogram method]]></article-title>
<source><![CDATA[Journal of Toxicology and Environmental Health]]></source>
<year>2011</year>
<volume>74</volume>
<numero>6</numero>
<issue>6</issue>
<page-range>351-63</page-range></nlm-citation>
</ref>
<ref id="B47">
<label>47</label><nlm-citation citation-type="">
<collab>Brasil. Ministério da Saúde</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária, Guia N.° 20 de 29 de maio de 2019]]></article-title>
<source><![CDATA[Guia sobre requisitos de qualidade para o registro de produtos tópicos e transdérmicos]]></source>
<year>2019</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B48">
<label>48</label><nlm-citation citation-type="">
<collab>Brasil. Ministério da Saúde</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária, Resolução de Diretoria Colegiada (RDC) N.° 200, de 26 de dezembro de 2017]]></article-title>
<source><![CDATA[Dispõe sobre os critérios para a concessão e renovação do registro de medicamentos com princípios ativos sintéticos e semissintéticos, classificados como novos, genéricos e similares]]></source>
<year>2017</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B49">
<label>49</label><nlm-citation citation-type="">
<collab>Brasil. Ministério da Saúde</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária, Resolução de Diretoria Colegiada (RDC) N.° 4 de 10 de fevereiro de 2009]]></article-title>
<source><![CDATA[Dispõe sobre as normas de farmacovigilância para os detentores de registro de medicamentos de uso humano]]></source>
<year>2009</year>
<publisher-loc><![CDATA[Brasilia ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B50">
<label>50</label><nlm-citation citation-type="">
<collab>Brasil. Presidência da República</collab>
<article-title xml:lang=""><![CDATA[Casa Civil, Lei N.° 11.794 de 8 de outubro de 2008]]></article-title>
<source><![CDATA[Regulamenta o inciso VIIdo § lo do art. 225 da Constituição Federal, estabelecendo procedimentos para o uso científico de animais; revoga a Lei N.° 6.638, de 8 de maio de 1979; e dá outras providências]]></source>
<year>2008</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B51">
<label>51</label><nlm-citation citation-type="">
<collab>Brasil. Ministério da Ciência Tecnologia e Inovação</collab>
<source><![CDATA[Gabinete do Ministro, Portaria N.° 491, de 3 de julho de 2012, Institui a Rede Nacional de Métodos Alternativos (Renama) e sua estrutura no âmbito do Ministério da Ciência, Tecnologia e Inovação (MCTI), que será supervisionada por um Conselho Diretor]]></source>
<year>2012</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B52">
<label>52</label><nlm-citation citation-type="">
<collab>Brasil. Ministério da Ciência Tecnologia e Inovação</collab>
<article-title xml:lang=""><![CDATA[Conselho Nacional de Controle e Experimentação Animal, Resolução Normativa N.° 18, de 24 de setembro de 2014]]></article-title>
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ueda]]></surname>
<given-names><![CDATA[C.T.]]></given-names>
</name>
<name>
<surname><![CDATA[Shah]]></surname>
<given-names><![CDATA[V.P.]]></given-names>
</name>
<name>
<surname><![CDATA[Derdzinski]]></surname>
<given-names><![CDATA[K.]]></given-names>
</name>
<name>
<surname><![CDATA[Ewing]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
<name>
<surname><![CDATA[Flynn]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
<name>
<surname><![CDATA[H. Maibach]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
</person-group>
<source><![CDATA[Reconhece métodos alternativos ao uso de animais em atividades de pesquisa no Brasil, nos termos da Resolução Normativa N.° 17, de 3 de julho de 2014, e dá outras providências]]></source>
<year>2014</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B53">
<label>53</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Marques]]></surname>
<given-names><![CDATA[H.]]></given-names>
</name>
<name>
<surname><![CDATA[Rytting]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Shaw]]></surname>
<given-names><![CDATA[K.]]></given-names>
</name>
<name>
<surname><![CDATA[Thakker]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Yacobi]]></surname>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[(The topical/transdermal ad hoc advisory panel for the USP performance tests of topical and transdermal dosage forms), Topical and transdermal drug products]]></article-title>
<source><![CDATA[Pharmacopeial Forum]]></source>
<year>2009</year>
<volume>35</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>750-64</page-range></nlm-citation>
</ref>
<ref id="B54">
<label>54</label><nlm-citation citation-type="journal">
<collab>Tripathi</collab>
<article-title xml:lang=""><![CDATA[Approaches for breaking the barriers of drug permeation through transdermal drug delivery]]></article-title>
<source><![CDATA[Journal of Controlled Release]]></source>
<year>2012</year>
<volume>164</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>26-40</page-range></nlm-citation>
</ref>
<ref id="B55">
<label>55</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Prausnitz]]></surname>
<given-names><![CDATA[M.R.]]></given-names>
</name>
<name>
<surname><![CDATA[Langer]]></surname>
<given-names><![CDATA[R.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Transdermal drug delivery]]></article-title>
<source><![CDATA[Nature Biotechnology]]></source>
<year>2008</year>
<volume>26</volume>
<numero>11</numero>
<issue>11</issue>
<page-range>1261-668</page-range></nlm-citation>
</ref>
<ref id="B56">
<label>56</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Bartosova]]></surname>
<given-names><![CDATA[L.]]></given-names>
</name>
<name>
<surname><![CDATA[Bajgar]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Transdermal drug delivery in vitro using diffusion cells]]></article-title>
<source><![CDATA[Current Medicinal Chemistry]]></source>
<year>2012</year>
<volume>19</volume>
<numero>27</numero>
<issue>27</issue>
<page-range>4671-7</page-range></nlm-citation>
</ref>
<ref id="B57">
<label>57</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Salamanca]]></surname>
<given-names><![CDATA[C.]]></given-names>
</name>
<name>
<surname><![CDATA[Barrera-Ocampo]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Lasso]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Camacho]]></surname>
<given-names><![CDATA[N.]]></given-names>
</name>
<name>
<surname><![CDATA[Yarce]]></surname>
<given-names><![CDATA[C.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Franz diffusion cell approach for preformulation characterisation of ketoprofen semi-solid dosage forms]]></article-title>
<source><![CDATA[Pharmaceutics]]></source>
<year>2018</year>
<volume>10</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>148</page-range></nlm-citation>
</ref>
<ref id="B58">
<label>58</label><nlm-citation citation-type="book">
<collab>Brasil. Ministério da Saúde</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária, Resolução de Diretoria Colegiada]]></article-title>
<source><![CDATA[Trata da admissibilidade das Farmacopéias estrangeiras]]></source>
<year>2009</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
<publisher-name><![CDATA[RDC]]></publisher-name>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
