Read While You Wait - Get immediate ebook access, if available*, when you order a print book

Safety Evaluation of Pharmaceuticals and Medical Devices

International Regulatory Guidelines

Authors: Gad, Shayne C.

Free Preview
  • Nonclinical safety assessment tests
  • Large molecules biotechnology products
  • National differences
see more benefits

Buy this book

eBook $119.00
price for USA in USD
  • ISBN 978-1-4419-7449-5
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $219.99
price for USA in USD
  • ISBN 978-1-4419-7448-8
  • Free shipping for individuals worldwide
  • Immediate ebook access, if available*, with your print order
  • Usually ready to be dispatched within 3 to 5 business days.
Softcover $159.99
price for USA in USD
  • ISBN 978-1-4899-8187-5
  • Free shipping for individuals worldwide
  • Immediate ebook access, if available*, with your print order
  • Usually ready to be dispatched within 3 to 5 business days.
About this book

Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approval. This intent is purposely extended to cover the closely related product types of vaccines, biotechnology products, gene therapy, cell therapy, and combination products into a single, concise guide for the process in all the major world market countries.

The approach of this volume is to first address the broadest scope “general case” for the regulatory nonclinical safety evaluation by ICH and ISO adhering countries, then to branch out to cover the differences in requirements associated with specific therapeutic areas (such as oncology), major routes of administration (with oral being the general case, other routes starting with parentheral, dermal and inhalation are addressed). Large molecules biotechnology products are then considered, followed by special courses of product marketing approval, and finally the remaining national differences.

About the authors

Shayne C. Gad, B.S. (Whittier College, Chemistry and Biology, 1970) and Ph.D. in Pharmacology/Toxicology (Texas, 1977) DABT, ATS, is the principal of Gad Consulting Services, a seventeen year old consulting firm with six employees and more than 450 clients (including 120 pharmaceutical companies in the US and 50 overseas). Prior to this, he served in director-level and above positions at Searle, Synergen and Becton Dickinson. He has published 39 books and more than 350 chapters, articles and abstracts in the fields of toxicology, statistics, pharmacology, drug development and safety assessment. He has more than 33 years of broad based experience in toxicology, drug and device development, statistics and risk assessment. He has specific expertise in neurotoxicology, in vitro methods, cardiovascular toxicology, inhalation toxicology, immunotoxicology, and genotoxicology. Past President of the American College of Toxicology, the Roundtable of Toxicology Consultants and three of SOT’s specialty sections, and recipient of the American College of Toxicology Lifetime Contribution Award. He has direct involvement in the preparation of INDs (90 successfully to date), NDA, PLA, ANDA, 510(k), IDE, CTD, clinical data bases for phase 1 and 2 studies, and PMAs. He has consulted for FDA, EPA and NIH, and has trained reviewers and been an expert witness for FDA. He has also conducted the triennial toxicology salary survey as a service to the profession for the last 19 years.

Table of contents (7 chapters)

Table of contents (7 chapters)

Buy this book

eBook $119.00
price for USA in USD
  • ISBN 978-1-4419-7449-5
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $219.99
price for USA in USD
  • ISBN 978-1-4419-7448-8
  • Free shipping for individuals worldwide
  • Immediate ebook access, if available*, with your print order
  • Usually ready to be dispatched within 3 to 5 business days.
Softcover $159.99
price for USA in USD
  • ISBN 978-1-4899-8187-5
  • Free shipping for individuals worldwide
  • Immediate ebook access, if available*, with your print order
  • Usually ready to be dispatched within 3 to 5 business days.
Loading...

Recommended for you

Loading...

Bibliographic Information

Bibliographic Information
Book Title
Safety Evaluation of Pharmaceuticals and Medical Devices
Book Subtitle
International Regulatory Guidelines
Authors
Copyright
2011
Publisher
Springer US
Copyright Holder
Springer Science+Business Media, LLC
eBook ISBN
978-1-4419-7449-5
DOI
10.1007/978-1-4419-7449-5
Hardcover ISBN
978-1-4419-7448-8
Softcover ISBN
978-1-4899-8187-5
Edition Number
1
Number of Pages
XI, 126
Topics

*immediately available upon purchase as print book shipments may be delayed due to the COVID-19 crisis. ebook access is temporary and does not include ownership of the ebook. Only valid for books with an ebook version. Springer Reference Works and instructor copies are not included.