Chi-Jen Lee, Cheng-Hsiung Lu, Lucia H Lee

Development and Evaluation of Drugs

From Laboratory Through Licensure to Market

• Gebundenes Buch

Produktbeschreibung

Since the initial publication of Development and Evaluation Drugs from Laboratory through Licensure to Market in 1993, many changes have occurred in biomedicine, biotechnology, pharmaceutical science and technology, and drug evaluation systems. Updated and expanded, this second edition examines all of the recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. Discussions include hot topics such as genome structure, rational drug design, good manufacturing practices, bioavailability and bioequivalence, and Phase IV post-marketing monitoring, and the final chapter explores future challenges.

Produktdetails

• Verlag: Taylor and Francis
• 2nd edition
• Seitenzahl: 256
• Erscheinungstermin: 28. Mai 2003
• Englisch
• Abmessung: 241mm x 161mm x 20mm
• Gewicht: 485g
• ISBN-13: 9780849314018
• ISBN-10: 0849314011
• Artikelnr.: 22221490

Autorenporträt

Chi Jen Lee, Cheng-Hsiung Lu, Lucia H. Lee

Inhaltsangabe

INTRODUCTION. Interdisciplinary Sciences for Drug Discovery. The Search for
Health - A Dream of Conquering Disease. Drug Development in the
Biotechnology Era. DRUG EVALUATION FROM LABORATORY THROUGH LICENSURE TO
PHARMACIST'S SHELF. Drug Evaluation Process and Licensure. Quality
Assurance-Regulation and Control Tests. References. PRACTICAL ASPECTS OF
DRUG EVALUATION AND RESPONSE. Generic Drugs and Orphan Drugs.
Pharmacokinetic Models for Drug Absorption. Factors Affecting Response to
Drugs. Mechanisms of Drug Interaction. Adverse Drug Reactions. Pregnancy
and Lactation. DEVELOPMENT OF NEW DRUG BY RESEARCH INSTITUTES AND THE
PHARMACEUTICAL INDUSTRY. Medical and Pharmaceutical Research in Drug
Development. Challenges in Preclinical Drug Testing. Strategies and
Planning for Clinical Trials - Good Clinical practice (GCP). Pharmaceutics
and Drug Delivery System. Regulatory Issues Involved in Plant Medicines.
CHALLENGING PROBLEMS FOR THE FUTURE. A Pursuit of Healthy and Happy Life in
an Aging Society. Aspects of Current Biomedical Research. The High Costs of
Health Care and Drug Development. Drug Safety and Global Health. Scientific
Advances to Revolutionize Modern Medicine. References.