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Clinical Trials of Drugs and Biopharmaceuticals

by Chi-Jen Lee (Editor), Lucia H. Lee (Editor), Christopher L. Wu (Editor),

Benjamin R. Lee (Editor), Mei-Ling Chen (Editor)



Editorial Reviews

Review
This book is useful because it consolidates information from preclinical and
clinical fields and also adds the perspective of regulatory agencies in bringing
drugs to marketdefinitely is more ambitious than the previous edition.
Alan Poisner, M.D., Doodys Book Review Service

This volume provides an overview of current procedures and major issues involved
in drug and biopharmaceutical development. The book examines critical
biochemical and pharmaceutical considerations for trials conducted during each
phase of clinical development. It also reports information related to early
pre-clinical evaluations of pharmacological activities and safety before
proceeding with the initiation of clinical trials. Practical and informative,
this step-by-step guide includes information on all four phases of clinical
trials prior to licensure and covers the design of post-marketing studies. The
editors examine how recent advances and increased demand for safer and more
effective drugs have changed the process by which drugs are developed and
approved.
In Anticancer Research, Vol. 26, 2006

Product Description
The pharmaceutical industry is on the verge of an exciting and challenging
century. Advances in pharmaceutical sciences have dramatically changed the
processes of discovery and development of new therapeutic drugs and, in turn,
resulted in an extraordinary increase in the potential prophylactic and
therapeutic interventions. In this atmosphere, an intimate understanding of the
mechanisms of pharmacokinetic and pharmacodynamic activity and the processes of
drug evaluation is essential.

Clinical Trials of Drugs and Biopharmaceuticals provides an overview of current
procedures and major issues involved in drug and biopharmaceutical development.
The book examines critical biochemical and pharmaceutical considerations for
trials conducted during each phase of clinical development. It also reports
information related to early pre-clinical evaluations of pharmacological
activities and safety before proceeding with initiation of clinical trials. The
sections focus on clinical assessments of drugs and biopharmaceuticals such as
cardiovascular, respiratory, central nervous system, gastrointestinal and liver,
genitourinary, skin, metabolism, and chemotherapeutic drugs as well as vaccines,
biotechnology-derived therapeutics, and plant-based medicines.
Practical and informative, this step-by-step guide includes information on all
four phases of clinical trials prior to licensure and covers the design of
post-marketing studies. The editors examine how recent advances and increased
demand for safer and more effective drugs have changed the process by which
drugs are developed and approved.


Product Details

Hardcover: 520 pages
Publisher: CRC; 1 edition (September 19, 2005)
Language: English
ISBN-10: 0849321859

 

 

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