Safety Pharmacology in Pharmaceutical Development and Approval
(Hardcover)
by Shayne C. Gad
Review
Editorial Reviews
(Hardcover)
by Shayne C. Gad
Review
Editorial Reviews
Review
[This] is the first book ever describing the specialty 'Safety Pharmacology' and it is a major contribution to understanding the increasing and demanding step from testing in animals to testing in humans. Gad's book is an excellent summary of the ideas on the way to deal with safety pharmacology tests in drug development processes. It gives a good overview of ideas and testing strategies combined with many examples. I can highly recommend reading the book . It would make an admirable primer for safety pharmacologists, toxicologists, and people engaged with preclinical testing.
- BTS Newsletter
Product Description
The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Conference on Harmonization (ICH) guidelines, safety pharmacology will become a more important phase in drug development. Safety Pharmacology in Pharmaceutical Development and Approval spells out the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery. Until recently, pharmacovigilance has been product-rather than utilization-oriented and often invisible in clinical medicine. It is clear that definitive safety pharmacology standards are needed to combat the increase in adverse reactions seen in the last 20 years. Giving you a head start in this emerging field, Safety Pharmacology in Pharmaceutical Development and Approval addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.
See all Editorial Reviews
Table of Contents
Ch. 1 Safety pharmacology: background, history, issues, and concerns 1 Ch. 2 Regulatory requirements of ICH, U.S. FDA, EMEA, and Japan MHW 17 Ch. 3 Principles of screening and study design 23 Ch. 4 Cardiovascular system 43 Ch. 5 Central nervous system 65 Ch. 6 Respiratory system 81 Ch. 7 Renal function 95 Ch. 8 The gastrointestinal system 109 Ch. 9 Safety pharmacology of the immune system 123 Ch. 10 Integration of evaluations of safety pharmacology endpoints into existing study designs 161 Selected regulatory and toxicological acronyms 177 Safety pharmacology labs 181 Index 185
[This] is the first book ever describing the specialty 'Safety Pharmacology' and it is a major contribution to understanding the increasing and demanding step from testing in animals to testing in humans. Gad's book is an excellent summary of the ideas on the way to deal with safety pharmacology tests in drug development processes. It gives a good overview of ideas and testing strategies combined with many examples. I can highly recommend reading the book . It would make an admirable primer for safety pharmacologists, toxicologists, and people engaged with preclinical testing.
- BTS Newsletter
Product Description
The Propulsid and Seldane drug disasters could have easily been avoided with more rigorous safety pharmacology studies of these compounds prior to any human clinical trials. Unfortunately, safety pharmacology has been overlooked by all but a few developers. With recent drug withdrawals from the market and the implementation of the International Conference on Harmonization (ICH) guidelines, safety pharmacology will become a more important phase in drug development. Safety Pharmacology in Pharmaceutical Development and Approval spells out the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery. Until recently, pharmacovigilance has been product-rather than utilization-oriented and often invisible in clinical medicine. It is clear that definitive safety pharmacology standards are needed to combat the increase in adverse reactions seen in the last 20 years. Giving you a head start in this emerging field, Safety Pharmacology in Pharmaceutical Development and Approval addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.
Table of Contents
Ch. 1 Safety pharmacology: background, history, issues, and concerns 1 Ch. 2 Regulatory requirements of ICH, U.S. FDA, EMEA, and Japan MHW 17 Ch. 3 Principles of screening and study design 23 Ch. 4 Cardiovascular system 43 Ch. 5 Central nervous system 65 Ch. 6 Respiratory system 81 Ch. 7 Renal function 95 Ch. 8 The gastrointestinal system 109 Ch. 9 Safety pharmacology of the immune system 123 Ch. 10 Integration of evaluations of safety pharmacology endpoints into existing study designs 161 Selected regulatory and toxicological acronyms 177 Safety pharmacology labs 181 Index 185
Product Details
Hardcover: 208 pages
Publisher: CRC; 1 edition
(August 26, 2003)
Language: English
ISBN-10: 0849313805
ISBN-13: 978-0849313806
Product Dimensions: 9.6 x 6.1 x 0.6 inches
Shipping Weight: 14.9 ounces
Download from here
http://rapidshare.com/files/1336460...n_pharmaceutical_development_and_approval.rar
(2292 KB)
Publisher: CRC; 1 edition
(August 26, 2003)
Language: English
ISBN-10: 0849313805
ISBN-13: 978-0849313806
Product Dimensions: 9.6 x 6.1 x 0.6 inches
Shipping Weight: 14.9 ounces
Download from here
http://rapidshare.com/files/1336460...n_pharmaceutical_development_and_approval.rar
(2292 KB)
