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Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.
Abend, Andreas M; Zhang, Limin; Fredro-Kumbaradzi, Emilija; Hoffelder, Thomas; Cohen, Michael J; Anand, Om; Delvadia, Poonam; Mandula, Haritha; Zhang, Zhen; Kotzagiorgis, Evangelos; Lum, Susan; Pereira, Victor Gomes; Barker, Amy; Lavrich, David; Kraemer, Johannes; Sharp-Suarez, Sandra.
Afiliação
  • Abend AM; Pharmaceutical Sciences, Merck, 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA. andreas_abend@merck.com.
  • Zhang L; Analytical Strategies and Operation, Bristol Myers Squibb Company, New Brunswick, New Jersey, 08903, USA.
  • Fredro-Kumbaradzi E; Biowaivers, Biocorrelation and Statistical Support, Global Research and Development, Apotex Inc, Toronto, Canada.
  • Hoffelder T; Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216, Ingelheim am Rhein, Germany.
  • Cohen MJ; Global Chemistry Manufacturing and Controls, Pfizer Worldwide Research & Development, Groton, Connecticut, USA.
  • Anand O; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Delvadia P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Mandula H; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Zhang Z; Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Kotzagiorgis E; European Medicines Agency, Pharmaceutical Quality Office, 1083 HS, Amsterdam, Netherlands.
  • Lum S; Bureau of Pharmaceutical Sciences, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Toronto, Canada.
  • Pereira VG; Office of Medicine Quality, Anvisa, SIA, Special Area 57, Brasília, DF, Brazil.
  • Barker A; Global Quality Laboratories, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, Indiana, 46285, USA.
  • Lavrich D; Analytical Commercialization Technology, Merck, 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA.
  • Kraemer J; DISSO GmbH, 66424, Homburg, Germany.
  • Sharp-Suarez S; Regulatory Affairs, Simulations Plus Inc., Lancaster, California, USA.
AAPS J ; 24(3): 50, 2022 03 29.
Article em En | MEDLINE | ID: mdl-35352186
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Indústria Farmacêutica / Motivação Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Indústria Farmacêutica / Motivação Tipo de estudo: Guideline / Prognostic_studies Limite: Humans País como assunto: America do norte Idioma: En Ano de publicação: 2022 Tipo de documento: Article