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 8
... associated with these barriers generally depend on the route of administra- tion . For example , endothelial barriers are important in targeting specific delivery to liver , lungs or reticular endothelial system ; cellular barriers are ...
... associated with these barriers generally depend on the route of administra- tion . For example , endothelial barriers are important in targeting specific delivery to liver , lungs or reticular endothelial system ; cellular barriers are ...
Page 10
... associated with bioavailability problems . For example , digitoxin , griseofulvin , some steroids , indomethacin , chlorpropamide and other drugs with low solubility are considered to have large variation in biological availability ...
... associated with bioavailability problems . For example , digitoxin , griseofulvin , some steroids , indomethacin , chlorpropamide and other drugs with low solubility are considered to have large variation in biological availability ...
Page 23
... associated with coronary artery occlusion and reperfusion in the isolated perfused rat heart : a model for assessement of antifibrillatory action of antiarrhythmic agents . Cardiovascular Res . , 12 , 212-20 Payne , A. N. , Garland ...
... associated with coronary artery occlusion and reperfusion in the isolated perfused rat heart : a model for assessement of antifibrillatory action of antiarrhythmic agents . Cardiovascular Res . , 12 , 212-20 Payne , A. N. , Garland ...
Page 41
... associated work ( such as analyses of test materials , etc. ) have been governed by a set of internationally agreed regulations , the Principles of Good Laboratory Practice ( Department of Health and Social Security , 1986 ) . The ...
... associated work ( such as analyses of test materials , etc. ) have been governed by a set of internationally agreed regulations , the Principles of Good Laboratory Practice ( Department of Health and Social Security , 1986 ) . The ...
Page 47
... show the site of action . Similarly , potent vasodilators , if they produce sustained hypotension and tachycardia , are associated with ECG changes , sometimes a rise in the plasma levels of certain enzymes. The toxicological background 47.
... show the site of action . Similarly , potent vasodilators , if they produce sustained hypotension and tachycardia , are associated with ECG changes , sometimes a rise in the plasma levels of certain enzymes. The toxicological background 47.
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