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 16
... possible , the evaluation of the NCE should be performed in parallel with a standard drug of the same therapeutic class . As with most of the advice given by the authorities , this approach can be regarded as good scientific policy ...
... possible , the evaluation of the NCE should be performed in parallel with a standard drug of the same therapeutic class . As with most of the advice given by the authorities , this approach can be regarded as good scientific policy ...
Page 21
... possible , examined in more detail , as an indication of a potential side - effect of the NCE . Platelet Function If appropriate , the activity of the NCE on human platelet aggregation can readily be assessed in vitro ( Born , 1962 ...
... possible , examined in more detail , as an indication of a potential side - effect of the NCE . Platelet Function If appropriate , the activity of the NCE on human platelet aggregation can readily be assessed in vitro ( Born , 1962 ...
Page 39
... possible the likely mechanisms of toxicity . From all these findings and analyses , a cautious prediction can be made of the possible nature and incidence of toxic effects in man , so that likely risks can be matched against anticipated ...
... possible the likely mechanisms of toxicity . From all these findings and analyses , a cautious prediction can be made of the possible nature and incidence of toxic effects in man , so that likely risks can be matched against anticipated ...
Page 45
... possible to the duration of activity or the half - life of the compound in the test species . Dose Levels A logical way to settle dose levels is to choose multiples of the therapeutically active dose in either animals or man , or of ...
... possible to the duration of activity or the half - life of the compound in the test species . Dose Levels A logical way to settle dose levels is to choose multiples of the therapeutically active dose in either animals or man , or of ...
Page 47
... possible to incorporate almost any type of exploration of physiological or biochemical function , or of pharmacological response , but the value of doing so depends on what is known from other experiments about the activities of the ...
... possible to incorporate almost any type of exploration of physiological or biochemical function , or of pharmacological response , but the value of doing so depends on what is known from other experiments about the activities of the ...
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