Early Phase Drug Evaluation in ManJohn O'Grady, Otto I Linet CRC Press, 2020 M02 3 - 737 pages Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs. |
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Results 1-5 of 88
Page v
... Quality Assurance B. Gennery 127 III . Ethical and Legal Considerations 137 12 . Ethical Aspects of Research in Healthy Volunteers S. J. Warrington 139 13. Ethical Aspects of Research in Patients F. Wells 14. Contents Table of Contents.
... Quality Assurance B. Gennery 127 III . Ethical and Legal Considerations 137 12 . Ethical Aspects of Research in Healthy Volunteers S. J. Warrington 139 13. Ethical Aspects of Research in Patients F. Wells 14. Contents Table of Contents.
Page vi
... Healthy Man 207 C. Broom 17. The Detection and Assessment of Adverse Reactions in Early Phase Patient Trials 214 J. N. Lessem and R. D. Mamelok 18. The Assessment of Pharmacodynamic Effects 220 J. D. Harry 19. The Assessment of ...
... Healthy Man 207 C. Broom 17. The Detection and Assessment of Adverse Reactions in Early Phase Patient Trials 214 J. N. Lessem and R. D. Mamelok 18. The Assessment of Pharmacodynamic Effects 220 J. D. Harry 19. The Assessment of ...
Page x
... healthy non - patient volunteer subjects and the early trials in patients , which provide the evidence of efficacy and relative safety which allow a decision to be made to progress to the later , comprehensive , stages of drug ...
... healthy non - patient volunteer subjects and the early trials in patients , which provide the evidence of efficacy and relative safety which allow a decision to be made to progress to the later , comprehensive , stages of drug ...
Page 53
... healthy - appearing embryos and the normality of their external , visceral and skeletal development . Litters born alive to the dams may be followed for up to 6 weeks for assessment of physical and neurological development . These ...
... healthy - appearing embryos and the normality of their external , visceral and skeletal development . Litters born alive to the dams may be followed for up to 6 weeks for assessment of physical and neurological development . These ...
Page 64
... healthy animals . ( 4 ) Species differences in anatomy and physiological functions Numerous adverse reactions to drugs are connected with functional disturbances of the central nervous system and the autonomic nervous system ...
... healthy animals . ( 4 ) Species differences in anatomy and physiological functions Numerous adverse reactions to drugs are connected with functional disturbances of the central nervous system and the autonomic nervous system ...
Contents
Organisation and Decision Making | 97 |
Ethical and Legal Considerations | 137 |
Measuring Drug Activity in Man | 193 |
Assessment of Drug Effects on the Cardiovascular System ... | 251 |
Assessment of Drug Effects on the Respiratory System ... | 349 |
Assessment of Drug Effects on the Central Nervous System ... | 377 |
Assessment of Drug Effects on the Gastrointestinal System ... | 455 |
Assessment of Drug Effects on the Kidney | 493 |
Assessment of the Effects of Drugs Used in Obstetrics and Gynaecology ... | 519 |
Assessment of Drug Activity in the Skin | 551 |
Assessment of Drugs Used for the Treatment of Metabolic Disorders ... | 599 |
Assessment of the Effects of Chemotherapeutic Agents ... | 625 |
Assessment of Drugs Affecting the Inflammatory Process and Pain ... | 655 |
Index | 703 |
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absorption acid action activity acute administration adverse agents analgesic animal antidepressant anxiety anxiolytic assay assessment asthma benzodiazepines bioavailability biological blood pressure cardiac output cells changes chronic Clin clinical research clinical trials compound concentration consent coronary corticosteroids determine disease diuretics dosage dose drug development duration eczema effects of drugs efficacy enantiomers enzyme ethics committee evaluation excretion exercise experimental factors function gastric gastrointestinal gastrointestinal tract glucose guidelines healthy volunteers heart human important increase induced inhibition insulin intravenous investigator laboratory levels measurement metabolism metabolites method minoxidil monitoring myocardial normal NSAIDs oral pain parameters patients performed Pharm pharmaceutical pharmacodynamic pharmacokinetic pharmacological placebo plasma platelet potential preclinical predictive produce prostaglandin protocol receptor regulatory renal response rheumatoid arthritis risk safety scales Shuster side-effects skin specific studies subjects symptoms techniques therapeutic therapy tion tolerance toxicology treatment urine uterine visual analogue scales vitro vivo