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.
General
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