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 87
Page 3
... usually require the greatest amount of investigation for safety and clinical evaluation to demonstrate their effectiveness . A compre- hensive discussion of all pharmaceutical considerations in the design and development of all dosage ...
... usually require the greatest amount of investigation for safety and clinical evaluation to demonstrate their effectiveness . A compre- hensive discussion of all pharmaceutical considerations in the design and development of all dosage ...
Page 4
... usually after regula- tory review and permission in most countries in the western world . When the decision is made to develop a compound , usually the first step is to prepare a reasonable quantity of drug substance so that ...
... usually after regula- tory review and permission in most countries in the western world . When the decision is made to develop a compound , usually the first step is to prepare a reasonable quantity of drug substance so that ...
Page 6
... ( usually for about 2 years ) , is elegant , contains the precise amount of drug which will deliver the drug in the most available form and can be manufactured on a large scale in an economic manner to meet market needs after regulatory ...
... ( usually for about 2 years ) , is elegant , contains the precise amount of drug which will deliver the drug in the most available form and can be manufactured on a large scale in an economic manner to meet market needs after regulatory ...
Page 10
... usually dissolve slowly in the gastrointestinal tract . The rate of dissolution may be the rate - determining step in the absorption process . Drugs with poor or low aqueous solubility often present the greatest challenge for ...
... usually dissolve slowly in the gastrointestinal tract . The rate of dissolution may be the rate - determining step in the absorption process . Drugs with poor or low aqueous solubility often present the greatest challenge for ...
Page 20
... usually only reported if the NCE is expected to have a direct effect on these parameters by virtue of its pharmacological profile . Studies of the spas- mogenic actions of the NCE on isolated gastrointestinal smooth muscle may also be ...
... usually only reported if the NCE is expected to have a direct effect on these parameters by virtue of its pharmacological profile . Studies of the spas- mogenic actions of the NCE on isolated gastrointestinal smooth muscle may also be ...
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