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 iv
... recording , or in any information storage or retrieval system , without written permission from the publishers . For permission to photocopy or use material electronically from this work , please access www.copyright.com ( http://www ...
... recording , or in any information storage or retrieval system , without written permission from the publishers . For permission to photocopy or use material electronically from this work , please access www.copyright.com ( http://www ...
Page 18
... recording any effects resulting from autonomic interactions in the behavioural studies , it is usual to evaluate the in vivo effects of the NCE on the autonomic nervous system in more detail , using appropriate pharma- cological ...
... recording any effects resulting from autonomic interactions in the behavioural studies , it is usual to evaluate the in vivo effects of the NCE on the autonomic nervous system in more detail , using appropriate pharma- cological ...
Page 46
... recorded should include RBCs , haematocrit and haemoglobin level , white cell and differential count , platelet count and comments on a stained smear . Such tests as the prothrombin time and the accelerated partial thrombo- plastin time ...
... recorded should include RBCs , haematocrit and haemoglobin level , white cell and differential count , platelet count and comments on a stained smear . Such tests as the prothrombin time and the accelerated partial thrombo- plastin time ...
Page 67
... recording of symptomatology and pathology , should be done instead . ( 3 ) No LD50 test should be conducted with pharmacologically inert subst- ances ( a maximum dose of 5 g / kg for oral administration and 2 g / kg for parenteral ...
... recording of symptomatology and pathology , should be done instead . ( 3 ) No LD50 test should be conducted with pharmacologically inert subst- ances ( a maximum dose of 5 g / kg for oral administration and 2 g / kg for parenteral ...
Page 140
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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