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
Processes FDA 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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Produktdetaljer
ISBN
9781118494882
Publisert
2018
Utgave
1. utgave
Utgiver
Vendor
Wiley Professional, Reference & Trade
Språk
Product language
Engelsk
Format
Product format
Digital bok
Forfatter