A history of a cGMP medical event investigation /

• Main Author: Brown, Michael A., 1945-
• Format: eBook
• Language: English
• Published: Hoboken, N.J. : John Wiley & Sons, [2013]
• Subjects: United States. > Food and Drug Administration.; Drugs > Side effects.; Adverse Drug Reaction Reporting Systems.; Drug Therapy > adverse effects.; Investigational New Drug Application.; Adverse Drug Reaction Reporting Systems > United States.; Drug Therapy > adverse effects > United States.; Investigational New Drug Application > United States.; United States.; United States. > Food and drug administration.; MEDICAL > Chemotherapy.; Electronic books.

Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six S...