Bioequivalence Requirements in Various Global Jurisdictions
(Sprache: Englisch)
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...
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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, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, theUSA and WHO will be of value 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.
Inhaltsverzeichnis zu „Bioequivalence Requirements in Various Global Jurisdictions “
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).Autoren-Porträt
Dr. Isadore Kanfer was appointed to the Chair as the first Professor of Pharmaceutics at Rhodes University in 1980 and served as Head of Pharmacy at Rhodes University and Dean of the Faculty from 1987-1989 and from 1999-2007. He established the Biopharmaceutics Research Institute (BRI) at Rhodes University and was its first Director. The BRI has successfully completed many bioequivalence studies on behalf of pharmaceutical companies. Professor Kanfer obtained his BSc (Pharmacy), BSc(Honours) and PhD in Pharmaceutics at Rhodes University and was Visiting Professor in Pharmaceutics at the University of California, San Francisco in 1980/81 and then in 1990 spent a year as Visiting Professor in the Division of Pharmaceutics at the University of North Carolina's School of Pharmacy in Chapel Hill, in the USA. He subsequently spent several years in the Pharmaceutical Industry in Canada where he was Vice-President: Scientific Affairs. He is an Associate Editor of the Journal of Pharmacy & Pharmaceutical Sciences and a member of the Editorial Board of Encyclopedia of Pharmaceutical Science and Technology.
Bibliographische Angaben
- 2018, Softcover reprint of the original 1st ed. 2017, X, 345 Seiten, 15 farbige Abbildungen, Maße: 15,5 x 23,5 cm, Kartoniert (TB), Englisch
- Herausgegeben: Isadore Kanfer
- Verlag: Springer, Berlin
- ISBN-10: 3319885421
- ISBN-13: 9783319885421
Sprache:
Englisch
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