Drugs
From Discovery to Approval
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Beschreibung
Statistics show that out of five thousand compounds with initialpromise, five will go into human clinical trials, and only one willbecome an approved drug. This tiny fraction illustrates the hugecomplexities involved in bringing a drug to market, a process thatbrings together scientific research, medical ethics, business, andvarious regulatory agencies.
Drugs-From Discovery to Approval presents a clear, step-by-stepoverview of the entire process. Using simple language, thiscomprehensive guide introduces basic concepts, then moves on todiscuss disease target selection and the discovery processes forboth small and large molecule drugs. Subsequent chapters explainpreclinical studies, clinical trials, regulatory issues, goodmanufacturing practices (GMPs), and perspectives on the future.Coverage also includes:
* A helpful listing of current FDA and European guidelines
* A special section on regulatory authorities and processes inJapan and China
* Rich illustrations throughout, including more than ninety figuresand tables
* Useful appendices on the history of drug discovery anddevelopment
* Representative examples of drug mechanisms in action
Written for professionals in the pharmaceutical industry, andreadily accessible for students of pharmacy or medicine and othersinterested in drug discovery, Drugs-From Discovery to Approvalrepresents a practical and approachable reference on this importantprocess.
Autor*in
Rick Ng
Themen in »Drugs«
Biotechnologie i. d. Biowissenschaften Biotechnology Biowissenschaften Chemie Chemistry Life Sciences Medical Science Medizin Pharmaceutical & Medicinal Chemistry Pharmacology & Pharmaceutical Medicine Pharmakologie Pharmakologie u. Pharmazeutische Medizin Pharmazeutische u. Medizinische Chemie
Stimmen zu »Drugs«
"...ideal for researchers who want a basic, unadornedpresentation of drug research and development." (Journal ofClinical Research Best Practices, October 2007)
"...a concise, no-nonsense overview of drug research anddevelopment from target identification to product manufacturing."(Journal of Clinical Research Practices, October 2007)
"...an exciting and novel text...excellent andessential text..." (Journal of Chemical Technology andBiotechnology, Vol. 80 (8), August 2005)
"...an exciting and novel text ...provides aconcise, yet comprehensive survey of the entire drug developmentprocess." (Journal of Chemical Technology andBiotechnology, 2005; Vol. 80, 964-965)
"...a practical reference source on this importantprocess." (Journal of the National MedicalAssociation, Vol.97, No.3, March 2005)
"...this book is appealing...the information...shouldprovide a greater understanding of social and ethical concernsregarding modern medications in a complex world." (Journal ofPharmacy Technology, November/ December 2004)
"...a concise guide to the subject...readable and clearlywritten...can be recommended for the general reader..."(Pharmaceutical Journal, 24 April 2004)
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