Dissolution Profile Similarity Assessment-Best Practices, Decision Trees and Global Harmonization.

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第一作者： Andreas M,Abend

第一单位： Pharmaceutical Sciences and Clinical Supplies, Merck Sharp & Dohme LLC, 126 E. Lincoln Avenue, Rahway, New Jersey, 07065, USA.

作者： Andreas M,Abend ^[1] ; Thomas,Hoffelder ^[2] ; Michael J,Cohen ^[3] ; Leslie,Van Alstine ^[4] ; Dorys Argelia,Diaz ^[3] ; Emilija,Fredro-Kumbaradzi ^[5] ; James,Reynolds ^[6] ; Yanbing,Zheng ^[6] ; Krista,Witkowski ^[7] ; Tycho,Heimbach ^[1]

作者单位： Pharmaceutical Sciences and Clinical Supplies, Merck Sharp & Dohme LLC, 126 E. Lincoln Avenue, Rahway, New Jersey, 07065, USA. ^[1] Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216, Ingelheim Am Rhein, Germany. thomas.hoffelder@boehringer-ingelheim.com. ^[2] Global Product Development, Chemistry Manufacturing and Controls, Pfizer Inc, Groton, Connecticut, USA. ^[3] Pharmaceutical Sciences and Manufacturing Statistics, Pfizer Worldwide Research & Development, Groton, Connecticut, USA. ^[4] Biowaivers, Biocorrelation and Statistical Support, Global Research and Development, Apotex Inc., Toronto, Canada. ^[5] Data and Statistical Sciences, AbbVie Inc., North Chicago, Illinois, 60064, USA. ^[6] Center for Mathematical Sciences, Merck & Co., Inc., Merck Manufacturing Division, Kenilworth, New Jersey, 07033, USA. ^[7]

关键词 clinically relevant dissolution specifications decision tree dissolution profile similarity safe space unknown clinical relevance approaches

主题词溶解度(Solubility)

DOI 10.1208/s12248-023-00795-5

PMID 37084114

发布时间 2023-05-19

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