<?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>S0034-74182023000200658</article-id>
<article-id pub-id-type="doi">10.15446/rcciquifa.v52n2.106421</article-id>
<title-group>
<article-title xml:lang="pt"><![CDATA[Análise crítica de três guias oficiais de validação de métodos analíticos em vigor no Brasil]]></article-title>
<article-title xml:lang="en"><![CDATA[Critical analysis of three official guides for the Validation of Analytical Methods in force in Brazil]]></article-title>
<article-title xml:lang="es"><![CDATA[Análisis crítico de tres guías oficiales de validación de métodos analíticos vigentes en Brasil]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vieira]]></surname>
<given-names><![CDATA[Debora Helena]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Moreira]]></surname>
<given-names><![CDATA[Wildeberg Cal]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Seródio]]></surname>
<given-names><![CDATA[Lilia Ribeiro]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Presgrave]]></surname>
<given-names><![CDATA[Octávio Augusto França]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Dallagiovanna]]></surname>
<given-names><![CDATA[Bruno]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Moura]]></surname>
<given-names><![CDATA[Wlamir Corrêa de]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Fundação Oswaldo Cruz  ]]></institution>
<addr-line><![CDATA[Rio de Janeiro RJ]]></addr-line>
<country>Brasil</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Fundação Oswaldo Cruz  ]]></institution>
<addr-line><![CDATA[Rio de Janeiro RJ]]></addr-line>
<country>Brasil</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Fundação Oswaldo Cruz  ]]></institution>
<addr-line><![CDATA[Curitiba PR]]></addr-line>
<country>Brasil</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,Fundação Oswaldo Cruz  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Brasil</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2023</year>
</pub-date>
<volume>52</volume>
<numero>2</numero>
<fpage>658</fpage>
<lpage>680</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0034-74182023000200658&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0034-74182023000200658&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0034-74182023000200658&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="pt"><p><![CDATA[RESUMO  Introdução a partir do século XX, com o surgimento das indústrias farmacêuticas após a descoberta da penicilina, acidentes envolvendo fármacos impulsionaram os avanços que culminaram na criação e adoção das boas práticas de fabricação nesta área e, paralelamente, dos princípios e uso mandatório das validações dos processos produtivos e métodos analíticos. Em geral, o guia de validação do ICH é o mais utilizado nesta área. No entanto, têm sido relatadas divergências nas definições dos parâmetros de validação contidos neste guia e em outros. No Brasil existem três guias oficiais em vigor (ANVISA, INMETRO e MAPA).  Objetivo analisar criticamente as definições das características de validação contidas nas normas brasileiras oficiais de validação e sua concordância com as definições padrão.  Métodos selecionar na literatura específica as definições das características de validação mais coerentes cientificamente e utilizá-las como definições padrão na avaliação das normas oficiais brasileiras.  Resultados verificou-se que a concordância das três normas oficiais brasileiras com as definições padrão foi de 37,5%, ANVISA; 50%, INMETRO e 62,5%, MAPA.  Conclusões é fundamental ter definições claras e cientificamente relevantes para as diferentes características de validação e utilizar métodos estatísticos adequados para a sua avaliação. Uma harmonização entre as diferentes normas oficiais seria de grande importância para evitar discrepâncias entre os setores regulados pelos diferentes orgãos no país.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction From the XX century, with the emergence of pharmaceutical industries after the discovery of penicillin, accidents involving drugs boosted advances that culminated in the creation and adoption of good manufacturing practices (GMPs) in that field and, in parallel, with the principles and mandatory use of validations of processes and analytical methods. In general, the ICH validation guide is the most used in this area. However, improprieties and discrepancies in the definitions of validation characteristics contained in this guide and others have been reported. In Brazil there are three official guides in force at present (ANVISA, INMETRO and MAPA).  Aim To critically analyze the definitions of the validation characteristics contained in the official Brazilian validation guidelines and their agreement with the standard definitions.  Methods the definitions were selected from the specific literature and use them as standard definitions in the evaluation of official Brazilian guidelines.  Results It was found that the agreement of the three official Brazilian norms with the standard definitions for the validation characteristics was 37.5%, ANVISA; 50%, INMETRO and 62.5%, MAPA.  Conclusions It is essential to have clear and scientifically relevant definitions for the different validation characteristics and to use appropriate statistical methods for its evaluation. Harmonization between the different official standards would also be important to avoid discrepancies between the sectors regulated by the different bodies in the country.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción a partir del siglo XX, con el surgimiento de las industrias farmacéuticas tras el descubrimiento de la penicilina, los accidentes con medicamentos impulsaron avances que culminaron con la creación y adopción de buenas prácticas de manufactura (BPM) en ese campo y, paralelamente, con los principios y uso obligatorio de validaciones de procesos y métodos analíticos. En general, la guía de validación del ICH es la más utilizada en este ámbito. Sin embargo, hay irregularidades y discrepancias en las definiciones de las características de validación contenidas en esta y otras guías. En Brasil existen actualmente tres guías oficiales vigentes (ANVISA, INMETRO y MAPA).  Objetivo analizar críticamente las definiciones de las características de validación contenidas en las directrices oficiales de validación brasileñas y su concordancia con las definiciones estándar.  Métodos seleccionar de la literatura específica las definiciones de las características de validación científicamente más coherentes y utilizarlas como definiciones estándar en la evaluación de las directrices oficiales brasileñas.  Resultados se constató que la concordancia de las tres normas oficiales brasileñas con las definiciones estándar para las características de validación fue del 37,5%, ANVISA, 50%, INMETRO y 62,5%, MAPA.  Conclusiones es fundamental tener definiciones claras y científicamente relevantes para las diferentes características de validación y utilizar métodos estadísticos apropiados para su evaluación. También sería importante la armonización entre las diferentes normas oficiales para evitar discrepancias entre los sectores regulados por los distintos organismos en el país.]]></p></abstract>
<kwd-group>
<kwd lng="pt"><![CDATA[Ensaios]]></kwd>
<kwd lng="pt"><![CDATA[métodos analíticos]]></kwd>
<kwd lng="pt"><![CDATA[validação]]></kwd>
<kwd lng="en"><![CDATA[Analytical methods]]></kwd>
<kwd lng="en"><![CDATA[assays]]></kwd>
<kwd lng="en"><![CDATA[validation]]></kwd>
<kwd lng="es"><![CDATA[Ensayo]]></kwd>
<kwd lng="es"><![CDATA[métodos analíticos]]></kwd>
<kwd lng="es"><![CDATA[validación]]></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[Patel]]></surname>
<given-names><![CDATA[K.T.]]></given-names>
</name>
<name>
<surname><![CDATA[Chotai]]></surname>
<given-names><![CDATA[N.P.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Pharmaceutical GMP: Past, present, and future &#8211; A review]]></article-title>
<source><![CDATA[Die Pharmazie]]></source>
<year>2007</year>
<volume>63</volume>
<page-range>251-5</page-range></nlm-citation>
</ref>
<ref id="B2">
<label>[2]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Jain]]></surname>
<given-names><![CDATA[S.K.]]></given-names>
</name>
<name>
<surname><![CDATA[Jain]]></surname>
<given-names><![CDATA[R.K.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Evolution of GMP in pharmaceutical industry]]></article-title>
<source><![CDATA[Res. J. Pharm. Tech.]]></source>
<year>2017</year>
<volume>10</volume>
<numero>2</numero>
<issue>2</issue>
<page-range>501-6</page-range></nlm-citation>
</ref>
<ref id="B3">
<label>[3]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Clarke]]></surname>
<given-names><![CDATA[B.L.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Symposium on Statistical Methods in Experimental and Industrial Chemistry. Introductory remarks]]></article-title>
<source><![CDATA[Anal. Chem.]]></source>
<year>1947</year>
<volume>19</volume>
<numero>12</numero>
<issue>12</issue>
<page-range>943</page-range></nlm-citation>
</ref>
<ref id="B4">
<label>[4]</label><nlm-citation citation-type="journal">
<collab>Brasil</collab>
<article-title xml:lang=""><![CDATA[Resolução de Diretoria Colegiada (RDC) nº 166, de 24 de julho de 2017]]></article-title>
<source><![CDATA[Diário Oficial da União]]></source>
<year>2017</year>
<numero>141</numero>
<issue>141</issue>
<publisher-loc><![CDATA[Brasília, DF ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B5">
<label>[5]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Araujo]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Key aspects of analytical method validation and linearity evaluation]]></article-title>
<source><![CDATA[J. Chromatogr. B: Analyt. Technol. Biomed. Life Sci.]]></source>
<year>2009</year>
<volume>877</volume>
<numero>23</numero>
<issue>23</issue>
<page-range>2224-34</page-range></nlm-citation>
</ref>
<ref id="B6">
<label>[6]</label><nlm-citation citation-type="book">
<collab>International Conference on Harmonization (ICH)</collab>
<source><![CDATA[Validation of analytical procedures: Text and methodology Q2 (R1)]]></source>
<year>2005</year>
<publisher-loc><![CDATA[Genebra, Suíça ]]></publisher-loc>
<publisher-name><![CDATA[International Conference on Harmonization (ICH)]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B7">
<label>[7]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hubert]]></surname>
<given-names><![CDATA[P.H.]]></given-names>
</name>
<name>
<surname><![CDATA[Nguyen-Huu]]></surname>
<given-names><![CDATA[J.J.]]></given-names>
</name>
<name>
<surname><![CDATA[Boulanger]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Chapuzet]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Chiap]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Cohen]]></surname>
<given-names><![CDATA[N.]]></given-names>
</name>
<name>
<surname><![CDATA[Compagnon]]></surname>
<given-names><![CDATA[P-A.]]></given-names>
</name>
<name>
<surname><![CDATA[Dewé]]></surname>
<given-names><![CDATA[W.]]></given-names>
</name>
<name>
<surname><![CDATA[Feinberg]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Lallier]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Laurentie]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Mercier]]></surname>
<given-names><![CDATA[N.]]></given-names>
</name>
<name>
<surname><![CDATA[Muzard]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
<name>
<surname><![CDATA[Nivet]]></surname>
<given-names><![CDATA[C.]]></given-names>
</name>
<name>
<surname><![CDATA[Valat]]></surname>
<given-names><![CDATA[L.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal -- Part I]]></article-title>
<source><![CDATA[J. Pharm. Biomed. Anal.]]></source>
<year>2004</year>
<volume>36</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>579-86</page-range></nlm-citation>
</ref>
<ref id="B8">
<label>[8]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Rozet]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Ceccato]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
<name>
<surname><![CDATA[Hubert]]></surname>
<given-names><![CDATA[C.]]></given-names>
</name>
<name>
<surname><![CDATA[Ziemons]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Oprean]]></surname>
<given-names><![CDATA[R.]]></given-names>
</name>
<name>
<surname><![CDATA[Rudaz]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Boulanger]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Hubert]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Analysis of recent pharmaceutical regulatory documents on analytical method validation]]></article-title>
<source><![CDATA[J. Chromatogr. A]]></source>
<year>2007</year>
<volume>1158</volume>
<numero>1-2</numero>
<issue>1-2</issue>
<page-range>111-25</page-range></nlm-citation>
</ref>
<ref id="B9">
<label>[9]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Possas]]></surname>
<given-names><![CDATA[J.L.S.]]></given-names>
</name>
<name>
<surname><![CDATA[Santos]]></surname>
<given-names><![CDATA[J.E. dos]]></given-names>
</name>
<name>
<surname><![CDATA[Nascimento]]></surname>
<given-names><![CDATA[M.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Santos]]></surname>
<given-names><![CDATA[P.A. dos]]></given-names>
</name>
<name>
<surname><![CDATA[Anjos]]></surname>
<given-names><![CDATA[D.W.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Moura]]></surname>
<given-names><![CDATA[W.C.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Uso do conceito do erro total, dos perfis de exatidão e do índice de exatidão no pré-estudo de validação de um ensaio imunoenzimático]]></article-title>
<source><![CDATA[Rev. Inst. Adolfo Lutz]]></source>
<year>2012</year>
<volume>71</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>691-705</page-range></nlm-citation>
</ref>
<ref id="B10">
<label>[10]</label><nlm-citation citation-type="book">
<collab>Brasil, Ministério da Agricultura, Pecuária e Abastecimento (MAPA)</collab>
<source><![CDATA[Guia de validação e controle de qualidade analítica: fármacos em produtos para alimentação e medicamentos veterinários]]></source>
<year>2011</year>
<publisher-loc><![CDATA[Brasília ]]></publisher-loc>
<publisher-name><![CDATA[Mapa/ACS]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B11">
<label>[11]</label><nlm-citation citation-type="">
<collab>Brasil, Ministério da Economia, Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO)</collab>
<source><![CDATA[Orientação sobre validação de métodos analíticos]]></source>
<year>2020</year>
<numero>DOQ-CGCRE-008, rev. 8</numero>
<issue>DOQ-CGCRE-008, rev. 8</issue>
</nlm-citation>
</ref>
<ref id="B12">
<label>[12]</label><nlm-citation citation-type="">
<collab>ABNT - Associação Brasileira de Normas Técnicas</collab>
<source><![CDATA[NBR ISO/IEC 17025:2017: Requisitos gerais para competência técnica de laboratórios de ensaio e calibração]]></source>
<year>2017</year>
<publisher-loc><![CDATA[Rio de Janeiro ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B13">
<label>[13]</label><nlm-citation citation-type="">
<collab>ANVISA - Agência Nacional de Vigilância Sanitária</collab>
<article-title xml:lang=""><![CDATA[Rede Brasileira de Laboratórios Analíticos em Saúde &#8211; Reblas]]></article-title>
<source><![CDATA[]]></source>
<year>2022</year>
</nlm-citation>
</ref>
<ref id="B14">
<label>[14]</label><nlm-citation citation-type="journal">
<collab>Brasil</collab>
<article-title xml:lang=""><![CDATA[Resolução de Diretoria Colegiada (RDC) nº 390, de 26 de maio de 2020]]></article-title>
<source><![CDATA[Diário Oficial da União]]></source>
<year>2020</year>
<numero>101</numero>
<issue>101</issue>
<publisher-loc><![CDATA[Brasília, DF ]]></publisher-loc>
</nlm-citation>
</ref>
<ref id="B15">
<label>[15]</label><nlm-citation citation-type="">
<collab>Ministério da Agricultura, Pecuária e Abastecimento (MAPA)</collab>
<article-title xml:lang=""><![CDATA[Credenciamento de Laboratório na Rede Nacional de Laboratórios Agropecuários do MAPA]]></article-title>
<source><![CDATA[]]></source>
<year>2022</year>
</nlm-citation>
</ref>
<ref id="B16">
<label>[16]</label><nlm-citation citation-type="">
<collab>AOAC International</collab>
<source><![CDATA[Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals]]></source>
<year>2002</year>
<numero>Int 95</numero>
<issue>Int 95</issue>
</nlm-citation>
</ref>
<ref id="B17">
<label>[17]</label><nlm-citation citation-type="book">
<collab>ISO</collab>
<source><![CDATA[Application of the Statistics-Accuracy (Trueness and Precision) of the Results and Methods of Measurement - Parts 1 to 6]]></source>
<year>2003</year>
<publisher-name><![CDATA[International Organization for Standardization (ISO)]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B18">
<label>[18]</label><nlm-citation citation-type="book">
<collab>ISO</collab>
<source><![CDATA[Statistics - Vocabulary and Symbols]]></source>
<year>2006</year>
<publisher-name><![CDATA[International Organization for Standardization (ISO)]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B19">
<label>[19]</label><nlm-citation citation-type="">
<collab>International Union of Pure and Applied Chemistry (IUPAC)</collab>
<source><![CDATA[Compendium of Chemical Terminology]]></source>
<year>2012</year>
<edition>Gold Book, Version 2.3.2.</edition>
</nlm-citation>
</ref>
<ref id="B20">
<label>[20]</label><nlm-citation citation-type="">
<collab>Brasil, Ministério da Economia, Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO)</collab>
<source><![CDATA[Vocabulário Internacional de Metrologia, Conceitos Fundamentais e Gerais e Termos Associado]]></source>
<year>2012</year>
<numero>Luso-Brasileira do VIM</numero>
<issue>Luso-Brasileira do VIM</issue>
</nlm-citation>
</ref>
<ref id="B21">
<label>[21]</label><nlm-citation citation-type="">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Barwick]]></surname>
<given-names><![CDATA[V.]]></given-names>
</name>
</person-group>
<collab>EURACHEM/CITAC</collab>
<source><![CDATA[Guide to Quality in Analytical Chemistry: An Aid to Accreditation]]></source>
<year>2016</year>
<edition>3rd</edition>
</nlm-citation>
</ref>
<ref id="B22">
<label>[22]</label><nlm-citation citation-type="">
<collab>EURACHEM GUIDE</collab>
<source><![CDATA[The Fitness for Purpose of Analytical Methods &#8211; A Laboratory Guide to Method Validation and Related Topics]]></source>
<year>2014</year>
<edition>2nd</edition>
</nlm-citation>
</ref>
<ref id="B23">
<label>[23]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Persson]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Vessman]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Generating selectivity in analytical chemistry to reach the ultimate -specificity]]></article-title>
<source><![CDATA[TrAC Trends in Analytical Chemistry]]></source>
<year>1998</year>
<volume>17</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>117-9</page-range></nlm-citation>
</ref>
<ref id="B24">
<label>[24]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hubert]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Chiap]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Crommen]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Boulanger]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Chapuzet]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
<name>
<surname><![CDATA[Mercier]]></surname>
<given-names><![CDATA[N.]]></given-names>
</name>
<name>
<surname><![CDATA[Bervoas-Martin]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
<name>
<surname><![CDATA[Chevalier]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Grandjean]]></surname>
<given-names><![CDATA[D.]]></given-names>
</name>
<name>
<surname><![CDATA[Lagorce]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Lallier]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Laparra]]></surname>
<given-names><![CDATA[M.C.]]></given-names>
</name>
<name>
<surname><![CDATA[Laurentie]]></surname>
<given-names><![CDATA[M.]]></given-names>
</name>
<name>
<surname><![CDATA[Nivet]]></surname>
<given-names><![CDATA[J.C.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The SFSTP Guide on the validation of chromatographic methods for drug bioanalysis: From the Washington Conference to the Laboratory]]></article-title>
<source><![CDATA[Anal. Chim. Acta]]></source>
<year>1999</year>
<volume>391</volume>
<page-range>135-48</page-range></nlm-citation>
</ref>
<ref id="B25">
<label>[25]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Boulanger]]></surname>
<given-names><![CDATA[B.]]></given-names>
</name>
<name>
<surname><![CDATA[Chiap]]></surname>
<given-names><![CDATA[P.]]></given-names>
</name>
<name>
<surname><![CDATA[Dewé]]></surname>
<given-names><![CDATA[W.]]></given-names>
</name>
<name>
<surname><![CDATA[Crommen]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
<name>
<surname><![CDATA[Hubert]]></surname>
<given-names><![CDATA[P.H.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[An analysis of the SFSTP guide on validation of chromatographic bioanalytical methods: progress and limitations]]></article-title>
<source><![CDATA[J. Pharm. Biomed. Anal.]]></source>
<year>2003</year>
<volume>32</volume>
<numero>4-5</numero>
<issue>4-5</issue>
<page-range>753-65</page-range></nlm-citation>
</ref>
<ref id="B26">
<label>[26]</label><nlm-citation citation-type="book">
<collab>AMC - Analytical Methods Committee</collab>
<article-title xml:lang=""><![CDATA[Technical Brief 13]]></article-title>
<source><![CDATA[]]></source>
<year>2003</year>
<publisher-loc><![CDATA[London ]]></publisher-loc>
<publisher-name><![CDATA[Royal Society of Chemistry]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B27">
<label>[27]</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hauck]]></surname>
<given-names><![CDATA[W.W.]]></given-names>
</name>
<name>
<surname><![CDATA[Koch]]></surname>
<given-names><![CDATA[W.F.]]></given-names>
</name>
<name>
<surname><![CDATA[Abernethy]]></surname>
<given-names><![CDATA[D.R.]]></given-names>
</name>
<name>
<surname><![CDATA[Williams]]></surname>
<given-names><![CDATA[R.L.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Making sense of trueness, precision, accuracy, and uncertainty]]></article-title>
<source><![CDATA[Pharmacopeial Forum]]></source>
<year>2008</year>
<volume>34</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>838-42</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
