Bioequivalence Requirements in Various Global Jurisdictions
Series: AAPS Advances in the Pharmaceutical Sciences Series; 61;
- Publisher's listprice EUR 213.99
-
90 774 Ft (86 451 Ft + 5% VAT)
The price is estimated because at the time of ordering we do not know what conversion rates will apply to HUF / product currency when the book arrives. In case HUF is weaker, the price increases slightly, in case HUF is stronger, the price goes lower slightly.
- Discount 8% (cc. 7 262 Ft off)
- Discounted price 83 512 Ft (79 535 Ft + 5% VAT)
90 774 Ft
Availability
Not yet published.
Why don't you give exact delivery time?
Delivery time is estimated on our previous experiences. We give estimations only, because we order from outside Hungary, and the delivery time mainly depends on how quickly the publisher supplies the book. Faster or slower deliveries both happen, but we do our best to supply as quickly as possible.
Product details:
- Edition number Second Edition 2025
- Publisher Springer
- Date of Publication 5 June 2025
- Number of Volumes 1 pieces, Book
- ISBN 9783031767739
- Binding Hardback
- No. of pages237 pages
- Size 235x155 mm
- Language English
- Illustrations 8 Illustrations, black & white; 16 Illustrations, color 700
Categories
Short description:
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.
MoreLong description:
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.
MoreTable of Contents:
Brazil.- Canada.- The European Union (EU).- India.- Japan.- The United States of America.- World Health Organization (WHO).
More
