Bioequivalence Requirements in Various Global Jurisdictions / / edited by Isadore Kanfer

• Pubblicazione: Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2025
• Edizione: 2nd ed. 2025.
• Descrizione fisica: 1 online resource (XIII, 237 p. 24 illus., 16 illus. in color.)
• Disciplina: 615.19
• Soggetto topico: Pharmaceutical chemistry; Pharmacovigilance; Pharmacology; Pharmaceutics; Drug Safety and Pharmacovigilance
• Persona (resp. second.): KanferIsadore
• Nota di contenuto: Brazil -- Canada -- The European Union (EU) -- India -- Japan -- The United States of America -- World Health Organization (WHO).
• Sommario/riassunto: An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions. In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.
• Titolo autorizzato: Bioequivalence Requirements in Various Global Jurisdictions
• ISBN: 3-031-76774-8
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910999669003321
• Lo trovi qui: Univ. Federico II
• Serie: AAPS Advances in the Pharmaceutical Sciences Series, . 2210-738X ; ; 61