Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets.

Jaiswal, Swati; Ahmed, Tausif; Kollipara, Sivacharan; Bhargava, Mohit; Chachad, Siddharth

Jaiswal, Swati; Ahmed, Tausif; Kollipara, Sivacharan; Bhargava, Mohit; Chachad, Siddharth.

Afiliação

Jaiswal S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.
Ahmed T; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.
Kollipara S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.
Bhargava M; Manufacturing Science And Technology (MSAT) Group, Dr. Reddy's Laboratories Ltd., Formulations Tech Operations (FTO)- Unit III, Bachupally, India.
Chachad S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.

Drug Dev Ind Pharm ; 47(5): 778-789, 2021 May.

Article em En | MEDLINE | ID: mdl-34082622

Assuntos

Biofarmácia; Modelos Biológicos; Administração Oral; Humanos; Solubilidade; Comprimidos; Equivalência Terapêutica

Palavras-chave

PBBM; PBPK; absorption modeling; dissolution specification; extended release; model validation; population simulation

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Biofarmácia / Modelos Biológicos Tipo de estudo: Clinical_trials / Prognostic_studies Limite: Humans Idioma: En Revista: Drug Dev Ind Pharm Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Índia

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