Drug Safety Evaluation , 4th Edition (EPUB)
Written by Shayne Cox Gad
Drug Safety Assessment
A thorough and useful manual providing a road map for safety assessment as a crucial component of medication and treatment development The main goal of this fourth edition of Drug Safety Evaluation remains the same: to provide a comprehensive, hands-on manual for anyone in charge of guaranteeing the safety of pharmaceuticals and biologics to patients, healthcare professionals and manufacturers, as well as anyone else who needs to know how these products’ safety is assessed and how to bring promising candidates to market.
Different ways to evaluating hazards are covered in detail in each chapter, along with discovered issues and their fixes. The philosophical and scientific foundations for assessing particular issues (such as development toxicity, carcinogenicity, etc.) are also discussed in order to offer insight and direction for tackling the recent issues that have confronted our society and the new difficulties they have brought up. Numerous developments in technology, pharmaceutical research, regulations, and the impact of Covid on science and society have necessitated both the creation of four new chapters and a thorough revision of every existing one.
Sample subjects specifically included in the Drug Safety Evaluation are :
The process of developing new drugs, the worldwide pharmaceutical industry, and the laws governing human pharmaceutical safety Information sources to be taken into account while designing studies, programs and safety assessments Formulations, routes and dose schedules; electronic records; reporting and submission; screens in safety and hazard assessment medication toxicity mechanisms and outcomes, pilot toxicity testing for medication safety assessment and repeat dose toxicity Testing for developmental and reproductive toxicity, toxicogenomics, nonrodent animal research, genotoxicity and QSAR techniques for drug safety An appendix that offers CROs the most recent guidelines for conducting studies Drug Safety Evaluation was created especially to provide a practical, yet scientifically sound, solution to the day-to-day problems associated with safety evaluation and the problem-solving needed for drug development and discovery.
It was written with scientists, consultants, and academics in the pharmaceutical and biotechnology industries in mind.
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