DISSOLUTION PROFILE SIMILARITY ANALYSES-STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.

Hoffelder, Thomas; Leblond, David; Van Alstine, Leslie; Diaz, Dorys Argelia; Suarez-Sharp, Sandra; Witkowski, Krista; Altan, Stan; Reynolds, James; Bergeron, Zachary; Lief, Kevin; Zheng, Yanbing; Abend, Andreas

Hoffelder, Thomas; Leblond, David; Van Alstine, Leslie; Diaz, Dorys Argelia; Suarez-Sharp, Sandra; Witkowski, Krista; Altan, Stan; Reynolds, James; Bergeron, Zachary; Lief, Kevin; Zheng, Yanbing; Abend, Andreas.

Afiliação

Hoffelder T; Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216, Ingelheim Am Rhein, Germany. thomas.hoffelder@boehringer-ingelheim.com.
Leblond D; Consultant in CMC Statistical Studies, 3091 Midlane Drive, Wadsworth, IL, 60083, United States of America.
Van Alstine L; Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, United States of America.
Diaz DA; Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, United States of America.
Suarez-Sharp S; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America.
Witkowski K; Regulatory Affairs, Simulations Plus Inc, 42505 10th Street West, Lancaster, CA, 93534, United States of America.
Altan S; Center for Mathematical Sciences, Merck Manufacturing Division, Merck & Co., Inc, Kenilworth, NJ, 07033, United States of America.
Reynolds J; Statistics and Decision Sciences, Manufacturing and Applied Statistics, Janssen Pharmaceutical R&D LLD, Raritan, NJ, 08869, United States of America.
Bergeron Z; Data and Statistical Sciences, AbbVie Inc, North Chicago, IL, 60064, United States of America.
Lief K; Agios Pharmaceuticals, 88 Sidney St., Cambridge, MA, 02143, United States of America.
Zheng Y; Sage Therapeutics, 215 First St, Cambridge, MA, 02142, United States of America.
Abend A; CMC Statistics, Biostatistics, GlaxoSmithKline, David Jack Centre for R&D, Ware, SG12 0DP, Hertfordshire, UK.

AAPS J ; 24(3): 54, 2022 04 06.

Article em En | MEDLINE | ID: mdl-35386051

Assuntos

Solubilidade; Baltimore

Palavras-chave

Decision tree; Dissolution similarity testing; Pairwise batch-to-batch comparisons; Similarity region; Standardized and non-standardized distance measures

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Solubilidade Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research País/Região como assunto: America do norte Idioma: En Revista: AAPS J Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Alemanha

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