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 86
Page 21
... less likely that these studies will attract such requirements . Another question that is receiving considerable attention at the present time is how , or whether , a compound which is known to be a mixture of isomers should be developed ...
... less likely that these studies will attract such requirements . Another question that is receiving considerable attention at the present time is how , or whether , a compound which is known to be a mixture of isomers should be developed ...
Page 31
... less than quantitative and / or presystemic metabolism of the drug occurs ( e.g. in the gut wall or liver for an orally administered drug ) , then blood levels of intact drug will differ after extravascular and intravenous ...
... less than quantitative and / or presystemic metabolism of the drug occurs ( e.g. in the gut wall or liver for an orally administered drug ) , then blood levels of intact drug will differ after extravascular and intravenous ...
Page 33
... less extensively distributed than weak bases , because weak acids are ionised to a greater extent at physiological pH than are weak bases , which inhibits their transport across cell membranes . Polar compounds do not enter the brain ...
... less extensively distributed than weak bases , because weak acids are ionised to a greater extent at physiological pH than are weak bases , which inhibits their transport across cell membranes . Polar compounds do not enter the brain ...
Page 36
... less are filtered through the glomerulus , and some bound and unbound drugs and metabolites are secreted by active transport . Reabsorp- tion of some drugs and metabolites occurs following glomerular filtration , mostly by passive ...
... less are filtered through the glomerulus , and some bound and unbound drugs and metabolites are secreted by active transport . Reabsorp- tion of some drugs and metabolites occurs following glomerular filtration , mostly by passive ...
Page 37
... less important than urinary or biliary excretion , the excretion of drugs in expired air , sweat , saliva , faeces and milk may be of consequence for specific drugs and circumstances . The secretion of drugs into milk is of concern and ...
... less important than urinary or biliary excretion , the excretion of drugs in expired air , sweat , saliva , faeces and milk may be of consequence for specific drugs and circumstances . The secretion of drugs into milk is of concern 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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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