Your browser doesn't support javascript.
loading
Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report.
Mackie, Claire; Arora, Sumit; Seo, Paul; Moody, Rebecca; Rege, Bhagwant; Pepin, Xavier; Heimbach, Tycho; Tannergren, Christer; Mitra, Amitava; Suarez-Sharp, Sandra; Borges, Luiza Novaes; Kijima, Shinichi; Kotzagiorgis, Evangelos; Malamatari, Maria; Veerasingham, Shereeni; Polli, James E; Rullo, Gregory.
Afiliação
  • Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.
  • Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium.
  • Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States.
  • Moody R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States.
  • Rege B; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States.
  • Pepin X; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States.
  • Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., 123 East Scott Ave., Rahway, New Jersey 07065, United States.
  • Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 83, Sweden.
  • Mitra A; Clinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States.
  • Suarez-Sharp S; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States.
  • Borges LN; ANVISA, SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil.
  • Kijima S; Office of New Drug V, Pharmaceutical and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan.
  • Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands.
  • Malamatari M; Medicines & Healthcare products Regulatory Agency, 10 South Colonnade, London E14 4PU, United Kingdom.
  • Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott Street, Ottawa, Ontario K1A 0K9, Canada.
  • Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States.
  • Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States.
Mol Pharm ; 21(5): 2065-2080, 2024 May 06.
Article em En | MEDLINE | ID: mdl-38600804
Assuntos
Palavras-chave
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Biofarmácia / Indústria Farmacêutica País/Região como assunto: America do norte Idioma: En Revista: Mol Pharm Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Bélgica
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Biofarmácia / Indústria Farmacêutica País/Região como assunto: America do norte Idioma: En Revista: Mol Pharm Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Bélgica