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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Page 18
... range of doses . Such studies in mice also serve to give an indication of the effect of the NCE on the autonomic nervous system ; for example , any influence of the NCE on salivation , pupil size , penile erection , ear coloration or ...
... range of doses . Such studies in mice also serve to give an indication of the effect of the NCE on the autonomic nervous system ; for example , any influence of the NCE on salivation , pupil size , penile erection , ear coloration or ...
Page 25
... range of the drug in animal species has been emphasised ( EEC Commission , 1980 ; Glockin , 1982 ) . Across - species assessments of exposure to drugs and their metabolites is best made on the basis of quantitative pharmacokinetic ...
... range of the drug in animal species has been emphasised ( EEC Commission , 1980 ; Glockin , 1982 ) . Across - species assessments of exposure to drugs and their metabolites is best made on the basis of quantitative pharmacokinetic ...
Page 27
... range of physiological , pathological , genetic and environmental factors . As a consequence , it is critical to control these factors in disposition studies and , where appropriate , study their effects . A brief description of the ...
... range of physiological , pathological , genetic and environmental factors . As a consequence , it is critical to control these factors in disposition studies and , where appropriate , study their effects . A brief description of the ...
Page 28
... range of doses used in pharmacology and safety studies . ( 4 ) The routes of administration and dosage formulations used in disposi- tion and safety studies should be comparable , except for disposition studies that are specifically ...
... range of doses used in pharmacology and safety studies . ( 4 ) The routes of administration and dosage formulations used in disposi- tion and safety studies should be comparable , except for disposition studies that are specifically ...
Page 30
... range , and the dissolution rate as a function of particle size or surface area of the compound ( Kaplan , 1973 ) . Even in the case of intravascu- lar drug administration , adequate aqueous solubility is necessary so that the drug does ...
... range , and the dissolution rate as a function of particle size or surface area of the compound ( Kaplan , 1973 ) . Even in the case of intravascu- lar drug administration , adequate aqueous solubility is necessary so that the drug does ...
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