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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Page 10
... cause haemolysis or incompatibility with blood components . In vitro techniques for studying precipitation potential upon injection and haemolysis potential have been reported and are employed in the drug developement ( Schroeder and ...
... cause haemolysis or incompatibility with blood components . In vitro techniques for studying precipitation potential upon injection and haemolysis potential have been reported and are employed in the drug developement ( Schroeder and ...
Page 17
... cause of such effects . In such cases , therefore , additional studies may be required - for example , by evaluation of the NCE in specific vascular beds in vivo or on isolated vascular tissues in vitro . The guidelines published by the ...
... cause of such effects . In such cases , therefore , additional studies may be required - for example , by evaluation of the NCE in specific vascular beds in vivo or on isolated vascular tissues in vitro . The guidelines published by the ...
Page 26
... cause major problems in safety assessment . Although high dose administration may reveal the toxic potential of ... causing a lower than expected exposure . Ideally , drug disposition studies should be conducted at an early enough stage ...
... cause major problems in safety assessment . Although high dose administration may reveal the toxic potential of ... causing a lower than expected exposure . Ideally , drug disposition studies should be conducted at an early enough stage ...
Page 30
... cause the aggregation of vascular components . ABSORPTION AND PHARMACOKINETICS Absorption and pharmacokinetic studies should be conducted very early in the drug evaluation process in conjunction with pharmacology and toxicology studies ...
... cause the aggregation of vascular components . ABSORPTION AND PHARMACOKINETICS Absorption and pharmacokinetic studies should be conducted very early in the drug evaluation process in conjunction with pharmacology and toxicology studies ...
Page 44
... cause lethality but to gain an impression of the range of actions produced . Interpretation of the findings depends ... causes in these species , and the availability of sufficient numbers of healthy , laboratory - bred animals for ...
... cause lethality but to gain an impression of the range of actions produced . Interpretation of the findings depends ... causes in these species , and the availability of sufficient numbers of healthy , laboratory - bred animals for ...
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