Case study details the right way and the wrong way to
successfully develop and market a new drug
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 Sigma
principles and methods should be applied to fully comply with FDA
regulations at every stage of drug development and
commercialization.
From initial transgenic mouse studies to the FDA fatality
investigation, this case study introduces all the key regulations
and practices that govern the development, manufacture, and
marketing of a new drug, including: FDA Investigational and New
Drug Application ProcessesFDA Code of Federal Regulations' current
Good Manufacturing Practice (cGMP)ISPE Good Automated Manufacturing
Practice (GAMP)
Readers will also be introduced to a variety of managers and
researchers whose personal agendas conflict with best practices and
therefore compromise the safety and effectiveness of a new drug
product. Throughout the case study, the author offers tested and
proven practices and tips so that these human flaws are not
translated into drug product flaws. These practices and tips are
critical and typically can only be learned through years of
experience working in competitive drug development
environments.
"A History of a cGMP Medical Event Investigation" is ideal for
students in biotechnology, pharmacology, engineering, and business
management as well as professionals in biomedical and drug
development. All readers will discover what can go wrong in
developing and bringing a new drug to market. Most importantly,
they will also learn how to apply Six Sigma principles and methods
to ensure safe and effective product design, development, and
manufacturing.
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