ICH Guideline for Good Clinical Practice and
the FDA CDER Handbook
This spiral-bound, 5" x 7.5" book consists of two documents translated into Spanish: The ICH Guideline for Good Clinical Practice and the FDA CDER Handbook on the drug approval process.
It contains a primer
on the drug development process, a review of how FDA evaluates and approves
drugs; as well as the responsibilities of sponsors, investigators, and IRBs/IECs
in protecting human subjects under Good Clinical Practice. It's an ideal
introduction for Spanish-speaking staff to the field of drug development and
a handy reference for seasoned Spanish-speaking clinical research professionals.
As more and more clinical trials are being conducted in Spanish-speaking countries, this books helps bridge the language barrier between Spanish-speaking and non-Spanish-speaking affiliates.
What's the Price?
• 1-249 copies: $14.95 • 250-499 copies: $13.95
• 500-749 copies: $12.95 • 750+ copies: $11.95
Custom Cover Prices*?
• 1-24 copies: unavailable • 25-100 copies: $2.00/book
• 100-249 copies: $1.00/book • 250+ copies: No charge
* Based on quantities of a single book title