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 6
... tion may be carried out as part of characterisation in addition to several other specific tests for purity and identity . For organic drug molecules , early chemical synthesis is often directed towards maximising chemical purity of the ...
... tion may be carried out as part of characterisation in addition to several other specific tests for purity and identity . For organic drug molecules , early chemical synthesis is often directed towards maximising chemical purity of the ...
Page 8
... tion . For example , endothelial barriers are important in targeting specific delivery to liver , lungs or reticular endothelial system ; cellular barriers are important for targeting to tumour and other specific cells ; and epithelial ...
... tion . For example , endothelial barriers are important in targeting specific delivery to liver , lungs or reticular endothelial system ; cellular barriers are important for targeting to tumour and other specific cells ; and epithelial ...
Page 9
... tion by one or more specific routes . A small fraction or most of the drug entity may eventually reach the receptor site , where the desired therapeutic response is achieved . PHYSICOCHEMICAL CONSIDERATIONS Table 1.4 shows some of the ...
... tion by one or more specific routes . A small fraction or most of the drug entity may eventually reach the receptor site , where the desired therapeutic response is achieved . PHYSICOCHEMICAL CONSIDERATIONS Table 1.4 shows some of the ...
Page 12
... 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.
... 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 16
... tion which illustrates the validity of the techniques and data . The guidelines published by the authorities also suggest that , where possible , the evaluation of the NCE should be performed in parallel with a standard drug of the same ...
... tion which illustrates the validity of the techniques and data . The guidelines published by the authorities also suggest that , where possible , the evaluation of the NCE should be performed in parallel with a standard drug of the same ...
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