Development, safety, Pharmaceutical, Pharmacology, Approval

Safety Pharmacology in Pharmaceutical Development and Approval

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.









List Price: $ 189.95



Price: $ 162.69









More Development Products

Other posts like this, by keyword:

Development:

201 Principles of Software Development ...
Modularity: Understanding the Development and Evolution of Natural Complex Systems (Vienna Series in Theoretical Biology) ...
From Neurons to Neighborhoods : The Science of Early Childhood Development ...
Incentives for Regional Development: Competition Among Sub-National Governments ...
Music and the Young Mind: Enhancing Brain Development and Engaging Learning ...
The World Economy: A Millennial Perspective/ Historical Statistics (Development Centre Studies) ...
Q&A: How can speech development be encouraged in young children? ...
The Continuing Professional Development of Educators: Emerging European Issues ...
Maturational Processes and the Facilitating Environment: Studies in the Theory of Emotional Development (Maresfield library) ...
Re-Visioning Television: Policy, Strategy and Models for the Sustainable Development of Community Television in South Africa (Hsrc Research ...
safety:

Latino Farmworkers in the Eastern United States: Health, Safety and Justice Reviews ...
Small Hydropower: Legal, Technical and Commercial Aspects / Pequenas Centrais Hidrelétricas: Aspectos Jurídicos, Técnicos e Comerciais (P ...
The Revolution Will Not Be Televised Revised Ed: Democracy, the Internet, and the Overthrow of Everything Reviews ...
Essential Oil Safety: A Guide for Health Care Professionals ...
To amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events th ...
Structural Design for Fire Safety ...
Online Safety For Your Child: Learn Internet Safety For Kids And Keep Your Children Safe On The Internet ...
Walking and Orienteering: A Complete Guide to Hiking for Fun and Competition: Map-reading, Compass Skills and Outdoor Safety ...
Parents reminded of pram safety tools ...
Earthquake science advances does nuclear safety keep up? ...
Pharmaceutical:

Be Brief. Be Bright. Be Gone.: Career Essentials for Pharmaceutical and Biotechnology Sales Representatives ...
Pharmacology:

Basic and Clinical Pharmacology, 11th Edition (LANGE Basic Science) ...
BRS Pharmacology (Board Review Series) ...
Single Up! ...
Pharmacology, Biology, and Clinical Applications of Androgens: Current Status and Future Prospects ...
Approval: