Retrospective analysis of the biopharmaceutics characteristics of solid oral Modified-Release drug products in approved US FDA NDAs designated as Extended-Release or Delayed-Release formulations.

Ahmed, Nadia; Ly, Holly; Pan, Amanda; Chiang, Brian; Raines, Kimberly; Janwatin, Timothy; Hamed, Salaheldin; Dave, Kaushalkumar

Ahmed, Nadia; Ly, Holly; Pan, Amanda; Chiang, Brian; Raines, Kimberly; Janwatin, Timothy; Hamed, Salaheldin; Dave, Kaushalkumar.

Afiliação

Ahmed N; U.S. Food and Drug Administration (FDA), United States. Electronic address: nadia.ahmed@fda.hhs.gov.
Ly H; CVS Pharmacy, United States.
Pan A; University of North Carolina, United States.
Chiang B; Pharmscript Pharmacy, United States.
Raines K; U.S. Food and Drug Administration (FDA), United States.
Janwatin T; Virginia Commonwealth School of Pharmacy, United States.
Hamed S; U.S. Food and Drug Administration (FDA), United States.
Dave K; U.S. Food and Drug Administration (FDA), United States.

Eur J Pharm Biopharm ; 193: 294-305, 2023 Dec.

Article em En | MEDLINE | ID: mdl-37984592

Assuntos

Biofarmácia; Polímeros; Estados Unidos; Humanos; Estudos Retrospectivos; United States Food and Drug Administration; Preparações de Ação Retardada; Comprimidos; Cápsulas

Palavras-chave

Biopharmaceutics; Delayed-release; Extended-release; FDA; Modified-release; Pharmacological advantages

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Polímeros / Biofarmácia Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Polímeros / Biofarmácia Idioma: En Ano de publicação: 2023 Tipo de documento: Article