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 85
Page 3
... techniques , fermentation or cell culture , isolation and purification steps . A decision to develop new drugs often depends on the results of ' screening ' , which involve testing of new drugs using whole animals or 3 1: The ...
... techniques , fermentation or cell culture , isolation and purification steps . A decision to develop new drugs often depends on the results of ' screening ' , which involve testing of new drugs using whole animals or 3 1: The ...
Page 4
... techniques to determine the pharmacological response which reflects potential therapeu- tic benefit ( s ) . Once the new drug has been shown to possess the desirable therapeutic or pharmacological promise through animal models or in ...
... techniques to determine the pharmacological response which reflects potential therapeu- tic benefit ( s ) . Once the new drug has been shown to possess the desirable therapeutic or pharmacological promise through animal models or in ...
Page 10
... techniques for studying precipitation potential upon injection and haemolysis potential have been reported and are employed in the drug developement ( Schroeder and Deluca , 1974 ; Yalkowsky et al . , 1983 ; Reed and Yalkowsky , 1985 ) ...
... techniques for studying precipitation potential upon injection and haemolysis potential have been reported and are employed in the drug developement ( Schroeder and Deluca , 1974 ; Yalkowsky et al . , 1983 ; Reed and Yalkowsky , 1985 ) ...
Page 11
... techniques , including the use of surface - active agents , e.g. polysorbates , sorbitan esters , quaternary ammo- nium compounds , sodium lauryl sulphates , etc. , are often valuable tools in overcoming the limitations in aqueous ...
... techniques , including the use of surface - active agents , e.g. polysorbates , sorbitan esters , quaternary ammo- nium compounds , sodium lauryl sulphates , etc. , are often valuable tools in overcoming the limitations in aqueous ...
Page 15
... techniques should be evaluated in a comparable fashion , but since these agents may pose specific problems , investigators will have to apply their best scientific judgment . REGULATORY REQUIREMENTS Although the USA and European ...
... techniques should be evaluated in a comparable fashion , but since these agents may pose specific problems , investigators will have to apply their best scientific judgment . REGULATORY REQUIREMENTS Although the USA and European ...
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