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 10
... reported and are employed in the drug developement ( Schroeder and Deluca , 1974 ; Yalkowsky et al . , 1983 ; Reed and Yalkowsky , 1985 ) . In whatever form the drug is presented or administered in the body , it must be available in the ...
... reported and are employed in the drug developement ( Schroeder and Deluca , 1974 ; Yalkowsky et al . , 1983 ; Reed and Yalkowsky , 1985 ) . In whatever form the drug is presented or administered in the body , it must be available in the ...
Page 14
... reported before permission for clinical study with the NCE will be granted . Since the requirements of the Japanese regulatory authority are also unique for the other preclinical disciplines , a separate chapter in this book is devoted ...
... reported before permission for clinical study with the NCE will be granted . Since the requirements of the Japanese regulatory authority are also unique for the other preclinical disciplines , a separate chapter in this book is devoted ...
Page 15
... reported . The authorities expect that the primary pharmacological properties of the NCE will be demonstrated by scientifically acceptable experimental techniques , and that these actions can be determined in vivo after administration ...
... reported . The authorities expect that the primary pharmacological properties of the NCE will be demonstrated by scientifically acceptable experimental techniques , and that these actions can be determined in vivo after administration ...
Page 16
... reported in the toxicology section of the application . However , a general pharmacological profile of the NCE is also required , with special attention to any effects additional to the primary pharmacological action . The aim of the ...
... reported in the toxicology section of the application . However , a general pharmacological profile of the NCE is also required , with special attention to any effects additional to the primary pharmacological action . The aim of the ...
Page 17
... reported under the headings listed in Table 2.1 . This list , therefore , gives an indication of the type of studies that the authorities expect to review . Although there are minor differences in the lists , principally in the ...
... reported under the headings listed in Table 2.1 . This list , therefore , gives an indication of the type of studies that the authorities expect to review . Although there are minor differences in the lists , principally in the ...
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