Drug Safety Evaluation
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- Synopsis
- This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics.* Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development* Explains scientific and philosophical bases for evaluation of specific concerns - including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity* Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars* Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation* Adds almost 20% new and thoroughly updates existing content from the last edition
- Copyright:
- 2017
Book Details
- Book Quality:
- Publisher Quality
- ISBN-13:
- 9781119097419
- Related ISBNs:
- 9781119097396
- Publisher:
- Wiley
- Date of Addition:
- 12/02/16
- Copyrighted By:
- Wiley
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Science, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.