<?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>2565-005X</journal-id>
<journal-title><![CDATA[Gaceta mexicana de oncología]]></journal-title>
<abbrev-journal-title><![CDATA[Gac. mex. oncol.]]></abbrev-journal-title>
<issn>2565-005X</issn>
<publisher>
<publisher-name><![CDATA[Sociedad Mexicana de Oncología A.C.]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2565-005X2024000400220</article-id>
<article-id pub-id-type="doi">10.24875/j.gamo.24000024</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Bioequivalence study between two formulations of 25 mg lenalidomide capsules in healthy male subjects]]></article-title>
<article-title xml:lang="es"><![CDATA[Estudio de bioequivalencia entre dos formulaciones de lenalidomida de 25 mg en sujetos hombres sanos]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sverdloff]]></surname>
<given-names><![CDATA[Carlos]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Marcondes-Rezende]]></surname>
<given-names><![CDATA[Vinícius]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cassia-Val]]></surname>
<given-names><![CDATA[Ligia de]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cedano-Limón]]></surname>
<given-names><![CDATA[Ma. Elena]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Nerath-Bonanato]]></surname>
<given-names><![CDATA[Lygia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pendela]]></surname>
<given-names><![CDATA[Murali]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Badii]]></surname>
<given-names><![CDATA[Mohammad H.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Kakarla]]></surname>
<given-names><![CDATA[Sreekanth]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castro]]></surname>
<given-names><![CDATA[Nelly C. Lemus]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,ATCGen Clinical Trials Clinical Operations Office ]]></institution>
<addr-line><![CDATA[Campinas ]]></addr-line>
<country>Brazil</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Eurofarma Laboratórios S.A. Medical Affairs, Clinical Projects Management ]]></institution>
<addr-line><![CDATA[Itapevi ]]></addr-line>
<country>Brazil</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Avant Santé Research Center S.A. de C.V., N.L. Scientific Office Bioequivalence Operations]]></institution>
<addr-line><![CDATA[San Pedro Garza García ]]></addr-line>
<country>Mexico</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2024</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2024</year>
</pub-date>
<volume>23</volume>
<numero>4</numero>
<fpage>220</fpage>
<lpage>225</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S2565-005X2024000400220&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S2565-005X2024000400220&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S2565-005X2024000400220&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  Background: Lenalidomide, derived from thalidomide, is vital for treating multiple myeloma and other blood cancers due to its immunomodulatory and anti-angiogenic effects. Ensuring bioequivalence between generic and branded forms is crucial, especially for public health affordability.  Objective: To evaluate pharmaceutical bioequivalence between two formulations of 25 mg lenalidomide capsules in healthy male subjects under fasting conditions.  Method: Conducted as an open label, monocentric, randomized, 2 x 2 crossover trial with 32 participants in fasting state, analyte concentrations were measured using UPLC-MS/MS, and then the pharmacokinetic parameters were determined.  Results: Statistical analysis has determined the geometric mean ratio (90% CI) of the test drug/reference drug for lenalidomide were 90.03 to 114.13% for Cmax and 88.21 to 101.02% for AUC0-t. Power of the test was 92.8% for Cmax and 100.0% for AUC0-t.  Conclusion: Both formulations are bioequivalent and, therefore, they are interchangeable, according to the Brazilian criteria, since confidence intervals for Cmax and AUC0-t ratios were within 80 and 125%.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Antecedentes: La lenalidomida, derivada de la talidomida, es vital para tratar el mieloma múltiple y otros cánceres de la sangre debido a sus efectos inmunomoduladores y antiangiogénicos. Asegurar la bioequivalencia entre las formas genéricas y las de marca es crucial, sobre todo, para la accesibilidad de la sanidad pública.  Objetivo: Evaluar la bioequivalencia farmacéutica entre dos formulaciones de cápsulas de lenalidomida de 25 mg en 32 hombres sanos en ayunas.  Método: Ensayo abierto, monocéntrico, aleatorizado, cruzado, donde se midieron las concentraciones de analitos por UPLC-MS/MS determinando los parámetros farmacocinéticos.  Resultados: El análisis estadístico ha determinado que la relación media geométrica (IC 90%) del fármaco de test/referencia fue de 90.03 a 114.13% para Cmax y de 88.21 a 101.02% para AUC0-t, con poder del test de 92.8 y 100.0% respectivamente.  Conclusión: Ambas formulaciones cumplieron los criterios brasileños de bioequivalencia, con intervalos de confianza para las relaciones Cmax y AUC0-t dentro del intervalo 80-125%, lo que confirma su intercambiabilidad.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Lenalidomide]]></kwd>
<kwd lng="en"><![CDATA[Bioequivalence]]></kwd>
<kwd lng="en"><![CDATA[Capsules]]></kwd>
<kwd lng="en"><![CDATA[Liquid chromatography-tandem mass spectrometry]]></kwd>
<kwd lng="en"><![CDATA[Immune modulator]]></kwd>
<kwd lng="en"><![CDATA[Antineoplastic]]></kwd>
<kwd lng="es"><![CDATA[Lenalidomida]]></kwd>
<kwd lng="es"><![CDATA[Bioequivalencia]]></kwd>
<kwd lng="es"><![CDATA[Cápsulas]]></kwd>
<kwd lng="es"><![CDATA[LC-MS/MS]]></kwd>
<kwd lng="es"><![CDATA[Inmunomodulador]]></kwd>
<kwd lng="es"><![CDATA[Antineoplásico]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<label>1</label><nlm-citation citation-type="">
<source><![CDATA[PubChem Compound Summary for CID 216326, Lenalidomide]]></source>
<year></year>
</nlm-citation>
</ref>
<ref id="B2">
<label>2</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Anderson]]></surname>
<given-names><![CDATA[KC]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Lenalidomide and thalidomide:mechanisms of action--similarities and differences]]></article-title>
<source><![CDATA[Semin Hematol]]></source>
<year>2005</year>
<volume>42</volume>
<page-range>S3-8</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[Chen]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
<name>
<surname><![CDATA[Borthakur]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Lenalidomide as a novel treatment of acute myeloid leukemia]]></article-title>
<source><![CDATA[Expert Opin Investig Drugs]]></source>
<year>2013</year>
<volume>22</volume>
<page-range>389-97</page-range></nlm-citation>
</ref>
<ref id="B4">
<label>4</label><nlm-citation citation-type="journal">
<collab>FDA-Food and Drug Administration</collab>
<article-title xml:lang=""><![CDATA[Drug Approval Package]]></article-title>
<source><![CDATA[Revlimid (Lenalidomide) Capsules. Celgene Corporation]]></source>
<year>2005</year>
</nlm-citation>
</ref>
<ref id="B5">
<label>5</label><nlm-citation citation-type="">
<collab>EMA</collab>
<source><![CDATA[Revlimid Lenalidomide]]></source>
<year>2007</year>
</nlm-citation>
</ref>
<ref id="B6">
<label>6</label><nlm-citation citation-type="journal">
<collab>ANVISA</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária]]></article-title>
<source><![CDATA[REVLIMID]]></source>
<year>2017</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B7">
<label>7</label><nlm-citation citation-type="book">
<collab>ANVISA</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária:resolução DA DIRETORIA COLEGIADA - RDC No 735, DE 13 DE JULHO DE 2022]]></article-title>
<source><![CDATA[Dispõe Sobre o Controle da Substância Lenalidomida e de Medicamento Que a Contenha, e dáOutras Providências]]></source>
<year>2022</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B8">
<label>8</label><nlm-citation citation-type="journal">
<collab>ANVISA</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária]]></article-title>
<source><![CDATA[Lenalidomida:autorizadas Novas Indicações Terapêuticas]]></source>
<year>2020</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B9">
<label>9</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Armoiry]]></surname>
<given-names><![CDATA[X]]></given-names>
</name>
<name>
<surname><![CDATA[Aulagner]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Facon]]></surname>
<given-names><![CDATA[T]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Lenalidomide in the treatment of multiple myeloma:a review]]></article-title>
<source><![CDATA[J Clin Pharm Ther]]></source>
<year>2008</year>
<volume>33</volume>
<page-range>219-26</page-range></nlm-citation>
</ref>
<ref id="B10">
<label>10</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Fine]]></surname>
<given-names><![CDATA[HA]]></given-names>
</name>
<name>
<surname><![CDATA[Kim]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Albert]]></surname>
<given-names><![CDATA[PS]]></given-names>
</name>
<name>
<surname><![CDATA[Duic]]></surname>
<given-names><![CDATA[JP]]></given-names>
</name>
<name>
<surname><![CDATA[Ma]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
<name>
<surname><![CDATA[Zhang]]></surname>
<given-names><![CDATA[W]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[A phase I trial of lenalidomide in patients with recurrent primary central nervous system tumors]]></article-title>
<source><![CDATA[Clin Cancer Res]]></source>
<year>2007</year>
<volume>13</volume>
<page-range>7101-6</page-range></nlm-citation>
</ref>
<ref id="B11">
<label>11</label><nlm-citation citation-type="book">
<collab>ANVISA</collab>
<source><![CDATA[Agência Nacional de Vigilância Sanitária:vigiMed - Eventos Adversos]]></source>
<year>2022</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B12">
<label>12</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Chan]]></surname>
<given-names><![CDATA[AW]]></given-names>
</name>
<name>
<surname><![CDATA[Tetzlaff]]></surname>
<given-names><![CDATA[JM]]></given-names>
</name>
<name>
<surname><![CDATA[Altman]]></surname>
<given-names><![CDATA[DG]]></given-names>
</name>
<name>
<surname><![CDATA[Laupacis]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Gøtzsche]]></surname>
<given-names><![CDATA[PC]]></given-names>
</name>
<name>
<surname><![CDATA[Krle&#382;a-Jeri&#263;]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[SPIRIT 2013 statement:defining standard protocol items for clinical trials]]></article-title>
<source><![CDATA[Ann Intern Med]]></source>
<year>2013</year>
<volume>158</volume>
<page-range>200-7</page-range></nlm-citation>
</ref>
<ref id="B13">
<label>13</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Chan]]></surname>
<given-names><![CDATA[AW]]></given-names>
</name>
<name>
<surname><![CDATA[Tetzlaff]]></surname>
<given-names><![CDATA[JM]]></given-names>
</name>
<name>
<surname><![CDATA[Gøtzsche]]></surname>
<given-names><![CDATA[PC]]></given-names>
</name>
<name>
<surname><![CDATA[Altman]]></surname>
<given-names><![CDATA[DG]]></given-names>
</name>
<name>
<surname><![CDATA[Mann]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
<name>
<surname><![CDATA[Berlin]]></surname>
<given-names><![CDATA[JA]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[SPIRIT 2013 explanation and elaboration:guidance for protocols of clinical trials]]></article-title>
<source><![CDATA[BMJ]]></source>
<year>2013</year>
<volume>346</volume>
</nlm-citation>
</ref>
<ref id="B14">
<label>14</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hopewell]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Boutron]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
<name>
<surname><![CDATA[Chan]]></surname>
<given-names><![CDATA[AW]]></given-names>
</name>
<name>
<surname><![CDATA[Collins]]></surname>
<given-names><![CDATA[GS]]></given-names>
</name>
<name>
<surname><![CDATA[de Beyer]]></surname>
<given-names><![CDATA[JA]]></given-names>
</name>
<name>
<surname><![CDATA[Hróbjartsson]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials]]></article-title>
<source><![CDATA[Nat Med]]></source>
<year>2022</year>
<volume>28</volume>
<page-range>1740-3</page-range></nlm-citation>
</ref>
<ref id="B15">
<label>15</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Schulz]]></surname>
<given-names><![CDATA[KF]]></given-names>
</name>
<name>
<surname><![CDATA[Altman]]></surname>
<given-names><![CDATA[DG]]></given-names>
</name>
<name>
<surname><![CDATA[Moher]]></surname>
<given-names><![CDATA[D]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[CONSORT 2010 statement:updated guidelines for reporting parallel group randomised trials]]></article-title>
<source><![CDATA[BMJ]]></source>
<year>2010</year>
<volume>340</volume>
<page-range>c332</page-range></nlm-citation>
</ref>
<ref id="B16">
<label>16</label><nlm-citation citation-type="book">
<collab>ANVISA</collab>
<source><![CDATA[Nacional de Vigilância Sanitária:resolução-RE No 894, DE 29 DE MAIO DE 2003:guia Para Elaboração de Protocolo de Estudo de Biodisponibilidade Relativa/Bioequivalênci]]></source>
<year>2003</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B17">
<label>17</label><nlm-citation citation-type="book">
<collab>ANVISA</collab>
<source><![CDATA[Agência Nacional de Vigilância Sanitária:resolução-RE No 895, de 29 de Maio De 2003:ANEXO - Guia Para Elaboração de Relatório Técnico de Estudo de Biodisponibilidade Relativa/Bioequivalência]]></source>
<year>2003</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B18">
<label>18</label><nlm-citation citation-type="book">
<collab>ANVISA</collab>
<source><![CDATA[Agência Nacional de Vigilância Sanitária:lista 1 - Forma de Administração (Formas Farmacêuticas de Liberação Imediata). RESOLUÇÃO - RE no 1170, de 19 de Abril de 2006]]></source>
<year>2022</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B19">
<label>19</label><nlm-citation citation-type="book">
<collab>ANVISA</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária:resolução - RE 1.170, de 19 De Abril De 2006]]></article-title>
<source><![CDATA[Guia Para Provas De Biodisponibilidade Relativa/Bioequivalência De Medicamentos]]></source>
<year>2006</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B20">
<label>20</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Lee]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Hwang]]></surname>
<given-names><![CDATA[JG]]></given-names>
</name>
<name>
<surname><![CDATA[Park]]></surname>
<given-names><![CDATA[SY]]></given-names>
</name>
<name>
<surname><![CDATA[Lim]]></surname>
<given-names><![CDATA[HJ]]></given-names>
</name>
<name>
<surname><![CDATA[Lee]]></surname>
<given-names><![CDATA[SW]]></given-names>
</name>
<name>
<surname><![CDATA[Seo]]></surname>
<given-names><![CDATA[MH]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Single-dose comparative pharmacokinetics of two formulations of lenalidomide 25 mg in healthy subjects:a randomized crossover study]]></article-title>
<source><![CDATA[Adv Ther]]></source>
<year>2018</year>
<volume>35</volume>
<page-range>210-7</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[Wang]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Qi]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Wang]]></surname>
<given-names><![CDATA[Z]]></given-names>
</name>
<name>
<surname><![CDATA[Chen]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Liu]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Liu]]></surname>
<given-names><![CDATA[Y]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Bioequivalence study of single-dose lenalidomide capsule vs. Revlimid® capsule in healthy Chinese males]]></article-title>
<source><![CDATA[Cancer Chemother Pharmacol]]></source>
<year>2018</year>
<volume>82</volume>
<page-range>159-64</page-range></nlm-citation>
</ref>
<ref id="B22">
<label>22</label><nlm-citation citation-type="">
<collab>FDA-Food and Drug Administration</collab>
<source><![CDATA[Draft Guidance on Lenalidomide]]></source>
<year>2013</year>
</nlm-citation>
</ref>
<ref id="B23">
<label>23</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Gay]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Hayman]]></surname>
<given-names><![CDATA[SR]]></given-names>
</name>
<name>
<surname><![CDATA[Lacy]]></surname>
<given-names><![CDATA[MQ]]></given-names>
</name>
<name>
<surname><![CDATA[Buadi]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Gertz]]></surname>
<given-names><![CDATA[MA]]></given-names>
</name>
<name>
<surname><![CDATA[Kumar]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Lenalidomide plus dexamethasone versus thalidomide plus dexamethasone in newly diagnosed multiple myeloma:a comparative analysis of 411 patients]]></article-title>
<source><![CDATA[Blood]]></source>
<year>2010</year>
<volume>115</volume>
<page-range>1343-50</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[Ranganathan]]></surname>
<given-names><![CDATA[P]]></given-names>
</name>
<name>
<surname><![CDATA[Gunasekaran]]></surname>
<given-names><![CDATA[V]]></given-names>
</name>
<name>
<surname><![CDATA[Singhvi]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
<name>
<surname><![CDATA[Ansari]]></surname>
<given-names><![CDATA[MJ]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Development and validation of Lenalidomide in human plasma by LC-MS/MS]]></article-title>
<source><![CDATA[Saudi J Biol Sci]]></source>
<year>2019</year>
<volume>26</volume>
<page-range>1843-7</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[Iqbal]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Wani]]></surname>
<given-names><![CDATA[TA]]></given-names>
</name>
<name>
<surname><![CDATA[Khalil]]></surname>
<given-names><![CDATA[NY]]></given-names>
</name>
<name>
<surname><![CDATA[Darwish]]></surname>
<given-names><![CDATA[IA]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Development and validation of ultra-performance liquid chromatographic method with tandem mass spectrometry for determination of lenalidomide in rabbit and human plasma]]></article-title>
<source><![CDATA[Chem Cent J]]></source>
<year>2013</year>
<volume>7</volume>
<page-range>7</page-range></nlm-citation>
</ref>
<ref id="B26">
<label>26</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hasnain]]></surname>
<given-names><![CDATA[MS]]></given-names>
</name>
<name>
<surname><![CDATA[Rao]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Singh]]></surname>
<given-names><![CDATA[MK]]></given-names>
</name>
<name>
<surname><![CDATA[Vig]]></surname>
<given-names><![CDATA[N]]></given-names>
</name>
<name>
<surname><![CDATA[Gupta]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Ansari]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Development and validation of LC-MS/MS method for the quantitation of lenalidomide in human plasma using Box-Behnken experimental design]]></article-title>
<source><![CDATA[Analyst]]></source>
<year>2013</year>
<volume>138</volume>
<page-range>1581-8</page-range></nlm-citation>
</ref>
<ref id="B27">
<label>27</label><nlm-citation citation-type="journal">
<collab>ANVISA</collab>
<article-title xml:lang=""><![CDATA[Agência Nacional de Vigilância Sanitária:lista 2 - Analito Para Estabelecimento da Biodisponibilidade Relativa/Bioequivalência]]></article-title>
<source><![CDATA[Resolução - RE no 1170, de 19 de abril de 2006]]></source>
<year>2022</year>
<publisher-loc><![CDATA[Brazil ]]></publisher-loc>
<publisher-name><![CDATA[ANVISA]]></publisher-name>
</nlm-citation>
</ref>
</ref-list>
</back>
</article>
