Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study.

Shaddinger, Bonnie; Mahar, Kelly M; Sprys, Mike; Andrews, Susan M; Chattoraj, Sayantan; Israni, Rubeen; Cobitz, Alex

Shaddinger, Bonnie; Mahar, Kelly M; Sprys, Mike; Andrews, Susan M; Chattoraj, Sayantan; Israni, Rubeen; Cobitz, Alex.

Afiliación

Shaddinger B; GSK, Collegeville, Pennsylvania, USA.
Mahar KM; GSK, Collegeville, Pennsylvania, USA.
Sprys M; GSK, Collegeville, Pennsylvania, USA.
Andrews SM; Global Clinical Operations Development R&D, GSK, Research Triangle Park, Durham, North Carolina, USA.
Chattoraj S; GSK, Collegeville, Pennsylvania, USA.
Israni R; GSK, Collegeville, Pennsylvania, USA.
Cobitz A; GSK, Collegeville, Pennsylvania, USA.

Clin Pharmacol Drug Dev ; 12(7): 739-748, 2023 07.

Article en En | MEDLINE | ID: mdl-37125459

Asunto(s)

Equivalencia Terapéutica; Humanos; Estudios Cruzados; Solubilidad; Comprimidos

Palabras clave

anemia; bioequivalence; chronic kidney disease; daprodustat; high-shear wet granulation; twin-screw granulation

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Equivalencia Terapéutica Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Drug Dev Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

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