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 53
Page viii
... Pain 655 50. Drugs Affecting the Immune Response 657 M. Rooney and G. Duff 51 . Anti - inflammatory Drugs P. S. Helliwell and V. Wright 52. Analgesics Index R. L. Holland 674 689 703 Regrettably , there is ample evidence that the time ...
... Pain 655 50. Drugs Affecting the Immune Response 657 M. Rooney and G. Duff 51 . Anti - inflammatory Drugs P. S. Helliwell and V. Wright 52. Analgesics Index R. L. Holland 674 689 703 Regrettably , there is ample evidence that the time ...
Page 11
... pain on injection ( Yalkowsky and Valvani , 1977 ; Morris , 1978 ) . For drugs with weak ionisable groups , an improvement in solubility for drug formulation can be achieved by controlling the pH within reasonable bounds , depending on ...
... pain on injection ( Yalkowsky and Valvani , 1977 ; Morris , 1978 ) . For drugs with weak ionisable groups , an improvement in solubility for drug formulation can be achieved by controlling the pH within reasonable bounds , depending on ...
Page 20
... some pharmaceutical companies . These studies may include inhibition of adjuvant - induced arthritis ( Curry and Ziff , 1968 ) and inhibition of carrageenan - induced hyperalgesia , pain or 20 Preliminaries to testing of drugs in man.
... some pharmaceutical companies . These studies may include inhibition of adjuvant - induced arthritis ( Curry and Ziff , 1968 ) and inhibition of carrageenan - induced hyperalgesia , pain or 20 Preliminaries to testing of drugs in man.
Page 21
... pain or oedema in rats ( Winter et al . , 1962 ; Vinegar et al . , 1973 ; Higgs et al . , 1988 ) . However , this information probably does not serve any major purpose unless appropriate for the anticipated clinical utility . These data ...
... pain or oedema in rats ( Winter et al . , 1962 ; Vinegar et al . , 1973 ; Higgs et al . , 1988 ) . However , this information probably does not serve any major purpose unless appropriate for the anticipated clinical utility . These data ...
Page 23
... pain threshold , respiratory frequency and gastrointestinal propulsion . Br . J. Pharmacol . Chemother . , 14 , 26-34 Higgs , G. A. , Follenfant , R. L. and Garland , L. G. ( 1988 ) . Selective inhibition of arachidonate 5 ...
... pain threshold , respiratory frequency and gastrointestinal propulsion . Br . J. Pharmacol . Chemother . , 14 , 26-34 Higgs , G. A. , Follenfant , R. L. and Garland , L. G. ( 1988 ) . Selective inhibition of arachidonate 5 ...
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 |
Other editions - View all
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