Drug Safety Evaluation (eBook)

Shayne Cox Gad (Autor)

eBook Download: EPUB

2016 | 3. Auflage
918 Seiten
John Wiley & Sons (Verlag)
978-1-119-09741-9 (ISBN)

Infos

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

Autor

Shayne Cox Gad, BS, PhD, DABT, has more than 39 years of experience in regulatory toxicology, drug and device development, statistics, and risk assessment. He is Principal of Gad Consulting Services, a firm with eight employees and more than 500 clients worldwide in the pharmaceutical and medical device industries. He is Past President of the American College of Toxicology (ACT), the Roundtable of Toxicology Consultants, and three of the Society of Toxicology's specialty sections. Dr. Gad received the 2008 ACT Lifetime Contribution Award and has authored or edited 47 books (10 with Wley) and more than 350 chapters, articles, and abstracts. Has preparated 110 INDs and 8 NDAs and teaches 3-5 professional education courses a year.

Rezensionen

"The stated goal of the third edition of Drug Safety Evaluation is to present an all-inclusive practical guide of how the safety of human drugs and biologics are evaluated. One just needs to peruse the table of contents to see that this book provides a comprehensive overview of human drug development as it applies to safety. The content encompasses the regulatory process for small molecules and biologics, and includes detailed descriptions of the toxicological tests that can be conducted and how the results are evaluated"... "Although the content is clearly meant for human pharma, this book will be useful to those involved in safety evaluations for veterinary drug development. The in-depth explanations of how data are evaluated from toxicity studies conducted for human drug development can be applied to animal drug development. The chapter on statistics in pharmaceutical safety assessment is particularly useful, with assumptions and limitations provided for each of the common statistical tests"...... "This comprehensive book on drug safety evaluation is a welcomed addition to my reference library" (Reviewed by Lesley C. Rausch-Derra, DVM, MS, Scout Bio Inc, Kansas City, Mo 15th June 2017)

Produkt-Details

• Erscheint lt. Verlag: 1.12.2016
• Reihe/Serie: Pharmaceutical Development
• Reihe/Serie: Pharmaceutical Development
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Gesundheitsfachberufe
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Naturwissenschaften ► Biologie ► Biochemie
• Themenwelt: Naturwissenschaften ► Chemie
• Themenwelt: Technik ► Medizintechnik
• Schlagworte: Arzneimittelsicherheit • Chemie • Chemistry • Medical Science • Medizin • Pharmacology & Pharmaceutical Medicine • Pharmakologie • Pharmakologie u. Pharmazeutische Medizin • Toxicology • Toxikologie • Veterinärmedizin • Veterinärmedizin / Pharmakologie, Toxikologie, Therapeutik • Veterinary Medicine • Veterinary Pharmacology, Toxicology & Therapeutics
• ISBN-10: 1-119-09741-X / 111909741X
• ISBN-13: 978-1-119-09741-9 / 9781119097419