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 54
Page 9
... involved in drug absorption and transport processes . Lipophilicity of the drug or the mem- brane - water partition coefficient and solubility are two of the most important properties of the drug molecule which have profound influence ...
... involved in drug absorption and transport processes . Lipophilicity of the drug or the mem- brane - water partition coefficient and solubility are two of the most important properties of the drug molecule which have profound influence ...
Page 12
... involved in the drug design 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 ...
... involved in the drug design 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 ...
Page 33
... involved in the binding and the drug , and has a major impact on the extent to which a drug is distributed , since the driving force for the distribution of passively transported drugs is the concentration of unbound drug . Albumin is ...
... involved in the binding and the drug , and has a major impact on the extent to which a drug is distributed , since the driving force for the distribution of passively transported drugs is the concentration of unbound drug . Albumin is ...
Page 47
... involved . Or , if a substance were found to depress spermatogene- sis , assays of appropriate pituitary and steroid hormones in blood might help to show the site of action . Similarly , potent vasodilators , if they produce sustained ...
... involved . Or , if a substance were found to depress spermatogene- sis , assays of appropriate pituitary and steroid hormones in blood might help to show the site of action . Similarly , potent vasodilators , if they produce sustained ...
Page 49
... involved ( Grice and Ciminera , 1988 ) . Current practice relies on tests in large numbers of rats and mice , or sometimes the Syrian hamster , given three dose levels ranging from the maximum tolerated dose , or 100-200 × the human ...
... involved ( Grice and Ciminera , 1988 ) . Current practice relies on tests in large numbers of rats and mice , or sometimes the Syrian hamster , given three dose levels ranging from the maximum tolerated dose , or 100-200 × the human ...
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