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 80
Page vi
... Activity in Man 193 15. The Assessment of Tolerance and Side - effects in Non - patient Volunteers 195 D. Jackson 16. Design of First - administration Studies in Healthy Man 207 C. Broom 17. The Detection and Assessment of Adverse ...
... Activity in Man 193 15. The Assessment of Tolerance and Side - effects in Non - patient Volunteers 195 D. Jackson 16. Design of First - administration Studies in Healthy Man 207 C. Broom 17. The Detection and Assessment of Adverse ...
Page vii
... Activity in the Skin 519 521 532 551 42. Measurement of Skin Response to Drugs S. Shuster , P. M. Farr and C. M. Lawrence 553 43. Drugs for Eczema J. R. Gibson and V. K. Manna 44. Drugs Affecting Hair Growth E. Novak 566 586 XII ...
... Activity in the Skin 519 521 532 551 42. Measurement of Skin Response to Drugs S. Shuster , P. M. Farr and C. M. Lawrence 553 43. Drugs for Eczema J. R. Gibson and V. K. Manna 44. Drugs Affecting Hair Growth E. Novak 566 586 XII ...
Page 15
... activities of the NCE . These secondary tests are sometimes referred to as the ' safety pharmacology evaluation ' but ... activity for the proposed therapeutic utility of the compound should be reported . The authorities expect that the ...
... activities of the NCE . These secondary tests are sometimes referred to as the ' safety pharmacology evaluation ' but ... activity for the proposed therapeutic utility of the compound should be reported . The authorities expect that the ...
Page 20
... activity of the NCE may be determined in mouse , rat , cat or dog preparations ( see Pool and Sonnenblick , 1967 ; Lawson , 1968 ; Wit et al . , 1970 ; Lubbe et al . , 1978 ) . The evaluation of the NCE on isolated vascular smooth ...
... activity of the NCE may be determined in mouse , rat , cat or dog preparations ( see Pool and Sonnenblick , 1967 ; Lawson , 1968 ; Wit et al . , 1970 ; Lubbe et al . , 1978 ) . The evaluation of the NCE on isolated vascular smooth ...
Page 21
... activity of the NCE on human platelet aggregation can readily be assessed in vitro ( Born , 1962 ; Whittle , 1987 ) and such an evaluation may provide useful preclinical information . Studies on platelet function ex vivo following ...
... activity of the NCE on human platelet aggregation can readily be assessed in vitro ( Born , 1962 ; Whittle , 1987 ) and such an evaluation may provide useful preclinical information . Studies on platelet function ex vivo following ...
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