The past two decades have witnessed significant advances in the biomedical sciences and in pharmacology. These advances have resulted in more stringent requirements in the testing, manufacturing and registration of medicinal products. This book deals with the regulation of medicinal products from both a national as well as an international perspective. It provides more details than those available in any other single publication on the applicable regulatory concepts, principles and approaches. The book is intended for a wide readership-drug regulators, policy-makers, legislators, pharmacists, pharmaceutical industry representatives, health lawyers, prescribing physicians etc.
The Time Has Come: A Novel
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