Bioequivalence Requirements in Various Global Jurisdictions

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Kanfer, Isadore (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2017.
• Σειρά: AAPS Advances in the Pharmaceutical Sciences Series, 28
• Θέματα: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biow...

Πίνακας περιεχομένων:

• Brazil
• Canada
• China
• The European Union
• India
• Bioequivalence Studies in Japan
• Middle East and North Africa (MENA) Bioequivalence Requirements
• Russia
• South Africa
• The United States of America
• World Health Organization (WHO).