New Drug Development: Second Edition provides an overview of the design
concepts and statistical practices involved in therapeutic drug
development. This wide spectrum of activities begins with identifying a
potentially useful drug candidate that can perhaps be used in the
treatment or prevention of a condition of clinical concern, and ends
with marketing approval being granted by one or more regulatory
agencies. In between, it includes drug molecule optimization,
nonclinical and clinical evaluations of the drug's safety and efficacy
profiles, and manufacturing considerations. The more inclusive term
lifecycle drug development can be used to encompass the postmarketing
surveillance that is conducted all the time that a drug is on the market
and being prescribed to patients with the relevant clinical condition.
Information gathered during this time can be used to modify the drug
(for example, dose prescribed, formulation, and mode of administration)
in terms of its safety and its effectiveness. The central focus of the
first edition of this book is captured by its subtitle, 'Design,
Methodology, and Analysis'. Optimum quality study design and
experimental research methodology must be employed if the data
collected--numerical representations of biological information--are to
be of optimum quality. Optimum quality data facilitate optimum quality
statistical analysis and interpretation of the results obtained, which
in turn permit optimum quality decisions to be made: Rational decision
making is predicated on appropriate research questions and optimum
quality numerical information. The book took a non-computational
approach to statistics, presenting instead a conceptual framework and
providing readers with a sound working knowledge of the importance of
design, methodology, and analysis. Not everyone needs to be an expert in
statistical analysis, but it is very helpful for work (or aspire to
work) in the pharmaceutical and biologics industries to be aware of the
fundamental importance of a sound scientific and clinical approach to
the planning, conduct, and analysis of clinical trials.
