Clinical Trials of Drugs and Biopharmaceuticals

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Chi-Jen Lee, Lucia H. Lee, Christopher L. Wu, Benjamin R. Lee, Mei-Ling Chen
CRC Press, 19 sept 2005 - 520 páginas
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
 

Índice

Preparation for Clinical Trials
1
CHAPTER 1 Drug Discovery and Preclinical Research
3
CHAPTER 2 The Pharmacuetical Background
9
CHAPTER 3 The Pharmacological Background for Drug Evaluation
23
CHAPTER 4 Animal Tests as Predictors of Human Response
31
Regulatory Organization and Decision Making
57
CHAPTER 5 Worldwide Regulatory Agencies
59
CHAPTER 6 Decision Point in Drug Development
77
CHAPTER 20 Antiulcer Drugs
291
Assessment of Genitourinary Drugs
303
CHAPTER 21 Diuretics
305
CHAPTER 22 Medical Therapy of Benign Prostatic Hyperplasia
317
Assessment of Skin Drugs
323
CHAPTER 23 Drugs for the Treatment of Specific Skin Diseases
325
CHAPTER 24 Drugs for the Treatment of Atopic Eczema
345
Assessment of Metabolism Drugs
353

CHAPTER 7 Management of Clinical Development Costs
87
CHAPTER 8 Ethical Aspects and Good Clinical Practice
103
CHAPTER 9 Investigational New Drug Appliation and the Licensure Approval Process
107
CHAPTER 10 Clinical Trials from Phase I to Phase IV
113
Evaluation and Quality Assurance of Drugs and Biopharmaceuticals
121
CHAPTER 11 The Assessment of Pharmacokinetics in EarlyPhase Drug Evaluation
123
CHAPTER 12 Drug Interactions
133
Assessment of Cardiovascular Drugs
143
CHAPTER 13 Antianginal Drugs
145
CHAPTER 14 Antihypertensive Drugs
165
CHAPTER 15 Drugs for Treatment of Stroke
201
Assessment of Respiratory Drugs
237
CHAPTER 16 Antiasthmatic Drugs
239
Assessment of Central Nervous System Drugs
249
CHAPTER 17 Anxiolytics and Hypnotics
251
CHAPTER 18 Antidepressants
269
CHAPTER 19 Drugs for Alzheimers Disease and Other Dementias
279
Assessment of Gastrointestinal and Liver Drugs
289
CHAPTER 25 Drugs for Treatment of Disorder of Lipid Metabolism
355
CHAPTER 26 Antidiabetic Drugs
363
Assessment of Chemotherapeutic Drugs
373
CHAPTER 27 Antibiotics
375
CHAPTER 28 Antiviral Drugs
391
CHAPTER 29 Anticancer Drugs
401
Assessment of Antiinflammatory and Pain Drugs
421
CHAPTER 30 Analgesics
423
Assessment of Biopharmaceuticals
443
CHAPTER 31 Vaccines
445
CHAPTER 32 Herbal Products as Complementary and Alternative Medicine
459
CHAPTER BiotechnologyDerived Pharmaceuticals
469
Future Perspectives
477
CHAPTER 34 Future Perspectives in Drug Development
479
CHAPTER 35 Future Perspectives in Biopharmaceutical Development
485
Index
493
Back cover
501
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Basic & Clinical Pharmacology
Bertram G. Katzung
No hay ninguna vista previa disponible - 2007

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

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