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 12
... and development process can significantly improve the rational selection or design of drug molecules for early evalua- tion in animals and humans . REFERENCES Amidon , G. L. , Sinko , P. J.. 12 Preliminaries to testing of drugs in man.
... and development process can significantly improve the rational selection or design of drug molecules for early evalua- tion in animals and humans . REFERENCES Amidon , G. L. , Sinko , P. J.. 12 Preliminaries to testing of drugs in man.
Page 13
John O'Grady, Otto I Linet. REFERENCES Amidon , G. L. , Sinko , P. J. and Fleisher , D. ( 1988 ) . Estimating human oral fraction dose absorbed : a correlation using rat intestinal membrane permeability for passive and carrier - mediated ...
John O'Grady, Otto I Linet. REFERENCES Amidon , G. L. , Sinko , P. J. and Fleisher , D. ( 1988 ) . Estimating human oral fraction dose absorbed : a correlation using rat intestinal membrane permeability for passive and carrier - mediated ...
Page 31
... reference formulation with which all other formulations can be compared . A number of physiologic- al factors influence oral absorption , including transit time , gastrointestinal pH , presence of food , microbial flora , and metabolic ...
... reference formulation with which all other formulations can be compared . A number of physiologic- al factors influence oral absorption , including transit time , gastrointestinal pH , presence of food , microbial flora , and metabolic ...
Page 37
... REFERENCES Ariens , E. J. ( 1966 ) . Receptor theory and structure - action relationships . Adv . Drug Res . , 3 , 235-85 Bousquet , W. F. ( 1970 ) . In Swarbrick , J. ( Ed . ) , Current Concepts in the Pharmaceutic- al Sciences ...
... REFERENCES Ariens , E. J. ( 1966 ) . Receptor theory and structure - action relationships . Adv . Drug Res . , 3 , 235-85 Bousquet , W. F. ( 1970 ) . In Swarbrick , J. ( Ed . ) , Current Concepts in the Pharmaceutic- al Sciences ...
Page 61
... REFERENCES Ashby , J. de Serres , F. , Shelby , M. D. , Margolin , B. H. , Ishidate , M. and Becking , G. C. ( 1988 ) . Evaluation of Short - Term Tests for Carcinogens , Volumes I , II . IPCS . Cambridge University Press Ashby , J. and ...
... REFERENCES Ashby , J. de Serres , F. , Shelby , M. D. , Margolin , B. H. , Ishidate , M. and Becking , G. C. ( 1988 ) . Evaluation of Short - Term Tests for Carcinogens , Volumes I , II . IPCS . Cambridge University Press Ashby , J. and ...
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