Clinical Trials of Drugs and BiopharmaceuticalsChi-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
1 | |
3 | |
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 |
Otras ediciones - Ver todo
Clinical Trials of Drugs and Biopharmaceuticals Chi-Jen Lee,Lucia H. Lee,Christopher L. Wu,Benjamin R. Lee,Mei-Ling Chen Vista previa restringida - 2005 |
Clinical Trials of Drugs and Biopharmaceuticals Chi-Jen Lee,Lucia H. Lee,Christopher L. Wu,Benjamin R. Lee,Mei-Ling Chen No hay ninguna vista previa disponible - 2005 |
Términos y frases comunes
absorption acid action activity acute addition administration adverse agents allow animal application approach approval assessment associated biological blood pressure cancer cause cells changes chemical chronic Clin clinical trials combination compared compound concentrations conducted considered costs decrease determine disease disorders diuretics dose drug drug development early effects efficacy enzymes established et al evaluation example exercise factors function gene glucose half-life healthy human hypertension immune important improve increase indicate infection inhibition inhibitors initial interactions involved levels major measured mechanisms Medicinal methods models myocardial infarction necessary observed occur oncology oral organ pain patients performed pharmaceutical pharmacokinetic phase plasma population possible potential preclinical prevent protein reactions receptor reduce regulatory reported response risk safety selection skin specific stroke studies subjects therapeutic therapy toxicity treated treatment usually vaccine