1st Edition

Clinical Trials of Drugs and Biopharmaceuticals

    520 Pages 11 B/W Illustrations
    by CRC Press

    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.

    Preparation for Clinical Trials
    Drug Discovery and Preclinical Research, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee
    The Pharmaceutical Background, S.C. Valvani
    The Pharmacological Background for Drug Evaluation, L.H. Lee, C.L Wu, B.R. Lee, and C.-J. Lee
    Animal Tests as Predictors of Human Response, P.I. Folb
    Regulatory Organization and Decision Making
    Worldwide Regulatory Agencies, C.-J. Lee, L.H. Lee, C.L.Wu, B.R. Lee, and M.-L. Chen
    Decision Points in Drug Development, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Management of Clinical Development Costs, M. Hovde
    Ethical Aspects and Good Clinical Practice, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Investigational New Drug Application and the Licensure Approval Process, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Clinical Trials from Phase I to Phase IV, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Evaluation anad Quality Assurance of Drugs and Biopharmaceuticals
    The Assessment of Pharmacokinetics in Early-Phase Drug Evaluation, P.E. Rolan and V. Molnar
    Drug Interactions, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Assessment of Cardiovascular Drugs
    Antianginal Drugs, N.C. Pauly
    Antihypertensive Drugs, W.S. Waring and D.J. Webb
    Drugs for Treatment of Stroke, M. Soehngen, W. Soehngen, and Y. Al-Rawi
    Assessment of Respiratory Drugs
    Antiasthmatic Drugs, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Assessment of Central Nervous System Drugs
    Anxiolytics and Hypnotics, G.R. McClelland and G. Moroz
    Antidepressants, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Drugs for Alzheimer ’s Disease and Other Dementias, B.R. Lee, L.H. Lee, C.L. Wu, and C.-J. Lee
    Assessmentof Gastrointestinal and Liver Drugs
    Antiulcer Drugs, B.R. Lee, L.H. Lee, C.L. Wu, and C.-J. Lee
    Assessment of Genitourinary Drugs
    Diuretics, H.H. Shah, P.C. Singhal, and J. Mattana
    Medical Therapy of Benign Prostatic Hyperplasia, B.R. Lee
    Assessment of Skin Drugs
    Drugs for the Treatment of Specific Skin Diseases, M.A. Haniffa, A.B. Alexandrov, S.N. Leech, and C.M. Lawrence
    Drugs for the Treatment of Atopic Eczema, C.L. Wu, L.H. Lee, B.R. Lee, and C.-J. Lee
    Assessment of Metabolism Drugs
    Drugs for Treatment of Disorders of Lipid Metabolism, C.L. Wu, L.H. Lee, B.R. Lee, and C.-J. Lee
    Antidiabetic Drugs, C.L. Wu, L.H. Lee, B.R. Lee, and C.-J. Lee
    Assessment of Chemotherapeutic Drugs
    Antibiotics, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Antiviral Drugs, L.H. Lee, C.L. Wu, B.R. Lee, and C.-J. Lee
    Anticancer Drugs, R.E. Martell, C. Langer, and R. Canetta
    Assessment of Antiinflammatory and Pain Drugs
    Analgesics, C.L. Wu, R.W. Hurley, and J.W. Stauffer
    Assessment of Biopharmaceuticals
    Vaccines, C.-J. Lee, L.H. Lee, C.L. Wu, B.R. Lee, and M.-L. Chen
    Herbal Products as Complementary and Alternative Medicine, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee
    Biotechnology-Derived Pharmaceuticals, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee
    Future Perspective
    Future Perspectives in Drug Development, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee
    Future Perspectives in Biopharmaceutical Development, C.-J. Lee, L.H. Lee, C.L. Wu, and B.R. Lee
    Index

    Biography

    Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen

    “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 market…definitely is more ambitious than the previous edition.”
    —Alan Poisner, M.D., Doody’s 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