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Development and Evaluation of Drugs : From Laboratory through Licensure to Market - Chi-Jen Lee

Development and Evaluation of Drugs

From Laboratory through Licensure to Market

Hardcover Published: 28th May 2003
ISBN: 9780849314018
Number Of Pages: 256

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Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market.
Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

Industry Reviews

"In this age of rapid changes it has become almost impossible to write a book which is up to date with the most recent changes. Nevertheless, the book succeeds in giving a broad and solid account of the subject and gives a reader without a strong background in the area a good introduction into the field in a very concise and well-structured way." - Pharmaceutical Research "[T]he appendix contains helpful information regarding general regulations for drugs and biological products. The text contains numerous black and white tables and figures that compliment and greatly enhance the text and make understanding the organisation and workings of the FDA more comprehensible. [A]n excellent introductory treatise in regulatory approval of drugs. [A]n excellent text, which achieves its goals, and would be a useful addition to any toxicology or pathology department's reference library." - BTS Newsletter, Summer 2004, Issue 24 Promo Copy

Introductionp. 1
Discovery and Development of Drugsp. 1
Search for Health--A Dream to Conquer Diseasesp. 3
Gods of Health and Healingp. 4
The Magic Bullets of Drugsp. 7
Drug Development in the Biotechnology Erap. 9
Expanding and Improving Research to Meet Global Health Needsp. 12
Genome Structure for Understanding the Encoded Proteinsp. 16
Drug Evaluation from Laboratory through Licensure to Pharmacist's Shelfp. 23
Drug Evaluation Process and Licensurep. 31
Drug Discovery and Preclinical Researchp. 31
Preclinical Developmentp. 32
Rational Drug Designp. 32
What Is a Patent and Its Application?p. 34
Animal Safety Testsp. 37
Acute Toxicity Studiesp. 37
Subacute and Chronic Toxicity Studiesp. 38
Reproductive and Developmental Toxicity Studiesp. 39
Mutagenicity Studyp. 46
Carcinogenicity Studyp. 48
Good Laboratory Practice Regulation and Inspectionp. 51
Assessment of Pharmacological Activitiesp. 60
Absorptionp. 61
Distributionp. 63
Metabolismp. 63
Excretionp. 64
Physicochemical Characterization and Stabilityp. 67
Drug Testing in People--Clinical Trialsp. 68
Investigational New Drug (IND) Applicationp. 69
Clinical Trial Designp. 70
Pre-IND Meeting between Regulatory Agency and Drug Sponsorp. 72
Clinical Trials from Phase I to Phase IVp. 73
New Drug Application (NDA) and Biologics License Application (BLA)p. 75
Information Required to Submit an NDA or BLAp. 76
Managed Review Processp. 78
Good Manufacturing Practice (GMP) Regulations and Facilityp. 81
General Backgroundp. 83
Facilities, Equipment, and Control Testingp. 83
Record, Personnel, and Monitoringp. 84
Postmarket Monitoring and Reporting Systemp. 85
Drug Evaluation Systems in Europe and Asiap. 88
European Regulatory Systemp. 88
Drug Approval and Regulation in Asiap. 90
Japanp. 90
Taiwanp. 96
International Conference on Harmonization (ICH) for Standardization and Simplified Regulationp. 100
Quality Assurance--Regulation and Control Testsp. 101
FDA's Basic Concept of Regulationp. 102
Lot Release Specifications and Control Testsp. 103
Control Tests for Bacterial Glycoconjugate Vaccinesp. 105
Regulatory Actionsp. 112
Practical Aspects of Drug Evaluation and Responsep. 117
Generic and Orphan Drugsp. 117
Pharmacokinetic Models for Drug Absorptionp. 119
Bioavailabilityp. 121
Pharmacokinetic Models and Their Clinical Applicationsp. 124
First-Order Eliminationp. 124
Nonlinear Eliminationp. 125
Regulatory Aspects of Bioequivalencep. 127
Factors Affecting Drug Responsep. 128
External Factors: Diet, Environmental Chemicals, Lifestylep. 129
Intrinsic Factors: Genetic Determinantsp. 130
Intrinsic Factors: Age and Disease Conditionsp. 131
Mechanisms of Drug Interactionp. 133
Receptor Sites of Drug Actionp. 134
Structure-Activity Relationship of Drugsp. 136
Adverse Drug Reactionsp. 136
Causal Relationship between Drugs and Adverse Reactionsp. 137
Adverse Reaction during Pregnancy and Lactationp. 139
Development of New Drugs by Research Institutes and the Pharmaceutical Industryp. 147
Medical and Pharmaceutical Research in Drug Developmentp. 147
Challenges in Preclinical Drug Testingp. 152
Strategies and Planning for Clinical Trialsp. 155
Phase I Trial--Safety and Early Clinical Pharmacologyp. 156
Phase II Trial--Clinical Efficacy and Safetyp. 157
Phase III Trial--Large-Scale Clinical Studiesp. 159
NDA Phase and Phase IV--Postmarketing Monitoringp. 161
Pharmaceutics and the Drug Delivery Systemp. 162
Regulatory Issues Involved in Plant Medicinesp. 166
Challenging Problems in the Futurep. 173
Pursuit of a Healthy and Happy Life in an Aging Societyp. 174
Aspects of Current Biomedical Researchp. 175
Vaccine Development for Prevention of Infectious Diseasesp. 175
Glycoconjugate Vaccinesp. 176
DNA Vaccinep. 177
Edible Vaccinep. 182
Resurgence in Search for Plant Medicinesp. 185
Studies on Metabolism of Plant Medicines--Kampo Glycosides Are Natural Prodrugsp. 186
Immunomodulating Herbal Polysaccharidesp. 188
Growing Interest in Alternative Medicinep. 193
Recombinant Biotechnology and Gene Therapyp. 194
Diet Factors and Drug Discovery in Cancer Researchp. 196
High Costs of Health Care and Drug Developmentp. 199
Drug Safety and Global Healthp. 201
Scientific Advances to Revolutionize Modern Medicinep. 207
Gene Technology and Stem Cells for Medical Therapeuticsp. 207
Cancer and Chronic Diseases in an Aging Societyp. 209
New Efforts in Countering Bioterrorismp. 212
Appendixp. 221
General Regulations for Drugs and Biological Productsp. 221
Part 200-299, Subchapter C--Drugs: Generalp. 221
Part 300-499, Subchapter D--Drugs for Human Usep. 221
Part 600-799, Subchapter F--Biologicsp. 221
Othersp. 222
Center for Drug Evaluation and Research (CDER), List of Important Guidelinesp. 222
Indexp. 231
Table of Contents provided by Ingram. All Rights Reserved.

ISBN: 9780849314018
ISBN-10: 0849314011
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 256
Published: 28th May 2003
Publisher: Taylor & Francis Inc
Country of Publication: US
Dimensions (cm): 23.5 x 15.88  x 1.91
Weight (kg): 0.5
Edition Number: 2
Edition Type: New edition

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