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. |
From inside the book
Results 1-5 of 83
Page 5
... mechanism effect of temperature photolytic degradation oxidation / hydrolysis presence of metal non - aqueous solution stability effect of additives Solid state stability : effect of temperature effect of humidity effect of light effect ...
... mechanism effect of temperature photolytic degradation oxidation / hydrolysis presence of metal non - aqueous solution stability effect of additives Solid state stability : effect of temperature effect of humidity effect of light effect ...
Page 8
... mechanisms . Similarly , the pH of the intestinal contents in various segments , the presence of bile salts and enzymes , the type and nature of food , the intestinal flora and the disease state will all influence the drug absorption ...
... mechanisms . Similarly , the pH of the intestinal contents in various segments , the presence of bile salts and enzymes , the type and nature of food , the intestinal flora and the disease state will all influence the drug absorption ...
Page 9
... mechanism : active transport passive diffusion facilitated diffusion Gastrointestinal pH : stomach duodenum jejunum ileum colon surface and bulk pH Stomach emptying and gastrointestinal motility : fasting non - fasting hydrodynamics ...
... mechanism : active transport passive diffusion facilitated diffusion Gastrointestinal pH : stomach duodenum jejunum ileum colon surface and bulk pH Stomach emptying and gastrointestinal motility : fasting non - fasting hydrodynamics ...
Page 15
... mechanism of the principal pharmacological action . However , it may not be possible to explain fully the mechanism of action of some novel compounds . Indeed , this is particularly true of compounds that have been identified and ...
... mechanism of the principal pharmacological action . However , it may not be possible to explain fully the mechanism of action of some novel compounds . Indeed , this is particularly true of compounds that have been identified and ...
Page 16
... mechanism . Although it is unlikely that a submission will fail if the pharmacological or biochemical mechanism of action is not fully elucidated , it is clearly desirable to establish the mode of action , if only for scientific and ...
... mechanism . Although it is unlikely that a submission will fail if the pharmacological or biochemical mechanism of action is not fully elucidated , it is clearly desirable to establish the mode of action , if only for scientific and ...
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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Common terms and phrases
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