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: $15.95 • 250-499 copies: $14.95
• 500-749 copies: $13.95 • 750+ copies: $12.95
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
• ICH E6: Guideline for Good Clinical Practice
[Guia Tripartita Armonizada de la Conferencia Internacional
de Amonizacion Lineamientos para la Buena Practica Clinica]
• FDA Center for Drug Evaluation and Research:
Handbook on the Drug Approval Process
[Manual del Centro para la Evaluacion e Investigacion de
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