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 84
Page 4
... 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 vitro techniques ...
... 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 vitro techniques ...
Page 9
... determine the limitation within which the drug may be formulated . Often , during the preclinical investigation phase , high concentrations or doses of drugs must be adminis- Table 1.4 Physicochemical considerations for drug delivery ...
... determine the limitation within which the drug may be formulated . Often , during the preclinical investigation phase , high concentrations or doses of drugs must be adminis- Table 1.4 Physicochemical considerations for drug delivery ...
Page 10
... determine the toxicological response . This creates a challenge for the pharmaceutical scientist , who must develop ... determining step in the absorption process . Drugs with poor or low aqueous solubility often present the greatest ...
... determine the toxicological response . This creates a challenge for the pharmaceutical scientist , who must develop ... determining step in the absorption process . Drugs with poor or low aqueous solubility often present the greatest ...
Page 22
... determine whether the pharmacological activities , both primary and secondary , reside in one specific isomer . A similar question being actively discussed within the scientific and legislative community is how compounds with known ...
... determine whether the pharmacological activities , both primary and secondary , reside in one specific isomer . A similar question being actively discussed within the scientific and legislative community is how compounds with known ...
Page 28
... determine the absorption and pharmacokinetic characteristics of different forms and formulations of the drug used in definitive safety studies . ( 6 ) Administration of drugs in safety studies as a bolus or as drug - diet mixtures ...
... determine the absorption and pharmacokinetic characteristics of different forms and formulations of the drug used in definitive safety studies . ( 6 ) Administration of drugs in safety studies as a bolus or as drug - diet mixtures ...
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