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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Results 1-5 of 90
Page v
... Human Response P. I. Folb 6. International Regulatory Requirements F. W. Teather 7. Regulatory Requirements in Japan Y. Yoshino 39 63 83 89 II . Organisation and Decision Making 8. The Organisation of New Drug Evaluation in the ...
... Human Response P. I. Folb 6. International Regulatory Requirements F. W. Teather 7. Regulatory Requirements in Japan Y. Yoshino 39 63 83 89 II . Organisation and Decision Making 8. The Organisation of New Drug Evaluation in the ...
Page 3
... humans and animals . Drug discovery and development involves a complex process from early discovery of a chemical entity to ... human testing will be covered . BACKGROUND The discovery phase of new chemical or molecular entities usually ...
... humans and animals . Drug discovery and development involves a complex process from early discovery of a chemical entity to ... human testing will be covered . BACKGROUND The discovery phase of new chemical or molecular entities usually ...
Page 4
... humans can begin , usually after regula- tory review and permission in most countries in the western world . When the ... human evaluation or for eventual marketing may not require extensive evaluation of all of these parameters . It ...
... humans can begin , usually after regula- tory review and permission in most countries in the western world . When the ... human evaluation or for eventual marketing may not require extensive evaluation of all of these parameters . It ...
Page 6
... human testing . In addition to analytical characterisation , determination of important physi- cochemical properties , such as melting point or boiling point , ionisation constant ( s ) for electrolyte drugs , isoelectric point for ...
... human testing . In addition to analytical characterisation , determination of important physi- cochemical properties , such as melting point or boiling point , ionisation constant ( s ) for electrolyte drugs , isoelectric point for ...
Page 13
... human oral fraction dose absorbed : a correlation using rat intestinal membrane permeability for passive and carrier - mediated compounds . Pharm . Res . , 5 , 651-4 Anderson , B. D. , Conradi , R. A. and Knuth , K. E. ( 1985a ) ...
... human oral fraction dose absorbed : a correlation using rat intestinal membrane permeability for passive and carrier - mediated compounds . Pharm . Res . , 5 , 651-4 Anderson , B. D. , Conradi , R. A. and Knuth , K. E. ( 1985a ) ...
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