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Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.
Grady, Haiyan; Elder, David; Webster, Gregory K; Mao, Yun; Lin, Yiqing; Flanagan, Talia; Mann, James; Blanchard, Andy; Cohen, Michael J; Lin, Judy; Kesisoglou, Filippos; Hermans, Andre; Abend, Andreas; Zhang, Limin; Curran, David.
Afiliação
  • Grady H; Pharmaceutical Sciences, Takeda Development Center Americas Inc., One Takeda Parkway, Deerfield, Illinois 60015. Electronic address: haiyan.grady@takeda.com.
  • Elder D; David P Elder Consultancy, Hertford, Hertfordshire SG14 2DE, UK.
  • Webster GK; Research and Development, AbbVie Inc., North Chicago, Illinois 60064.
  • Mao Y; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, Pennsylvania 19486.
  • Lin Y; Analytical Development, Biogen Inc., Cambridge, Massachusetts 02142.
  • Flanagan T; Pharmaceutical Technology and Development, AstraZeneca R&D, Macclesfield, Cheshire, UK.
  • Mann J; Pharmaceutical Technology and Development, AstraZeneca R&D, Macclesfield, Cheshire, UK.
  • Blanchard A; Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut 06340.
  • Cohen MJ; Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut 06340.
  • Lin J; Biologics Technical Development and Manufacturing, Novartis, East Hanover, New Jersey 07936.
  • Kesisoglou F; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, Pennsylvania 19486.
  • Hermans A; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, Pennsylvania 19486.
  • Abend A; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., West Point, Pennsylvania 19486.
  • Zhang L; Drug Product Science and Technology, Bristol Myers Squibb Company, New Brunswick, New Jersey 08903.
  • Curran D; Analytical Sciences and Development, GlaxoSmithKline, King of Prussia Pennsylvania 19406.
J Pharm Sci ; 107(1): 34-41, 2018 01.
Article em En | MEDLINE | ID: mdl-29074376
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Preparações Farmacêuticas Limite: Animals / Humans Idioma: En Revista: J Pharm Sci Ano de publicação: 2018 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Preparações Farmacêuticas Limite: Animals / Humans Idioma: En Revista: J Pharm Sci Ano de publicação: 2018 Tipo de documento: Article