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 55
Page vii
... Skin 519 521 532 551 42. Measurement of Skin Response to Drugs S. Shuster , P. M. Farr and C. M. Lawrence 553 43. Drugs for Eczema J. R. Gibson and V. K. Manna 44. Drugs Affecting Hair Growth E. Novak 566 586 XII . Assessment of Drugs ...
... Skin 519 521 532 551 42. Measurement of Skin Response to Drugs S. Shuster , P. M. Farr and C. M. Lawrence 553 43. Drugs for Eczema J. R. Gibson and V. K. Manna 44. Drugs Affecting Hair Growth E. Novak 566 586 XII . Assessment of Drugs ...
Page 34
... skin , lung , small intestine and gastrointestinal flora may have a significant impact on biotransformation , depending on the drug , the drug dose and the route of exposure ( Lake and Gangolli , 1981 ) . Many factors are now known that ...
... skin , lung , small intestine and gastrointestinal flora may have a significant impact on biotransformation , depending on the drug , the drug dose and the route of exposure ( Lake and Gangolli , 1981 ) . Many factors are now known that ...
Page 41
... skin , eye , rectum or vagina . Similarly , parenteral administration will require testing by the chosen route , both for local and systemic effects , although the extent and nature of the studies may be modified if the substance has ...
... skin , eye , rectum or vagina . Similarly , parenteral administration will require testing by the chosen route , both for local and systemic effects , although the extent and nature of the studies may be modified if the substance has ...
Page 55
... skin and lungs , the possibility of sensitisation ) and systemic dosing by an appropriate route to reveal any general risks following absorption . Local studies are self - evident ; considerable technical skill is required , for example ...
... skin and lungs , the possibility of sensitisation ) and systemic dosing by an appropriate route to reveal any general risks following absorption . Local studies are self - evident ; considerable technical skill is required , for example ...
Page 57
... skin disorders or as tissue swelling , acute bronchoconstriction and even shock on challenge . They are rarely predictable from the results of conventional toxicity tests , and to produce them in animals for study may require special ...
... skin disorders or as tissue swelling , acute bronchoconstriction and even shock on challenge . They are rarely predictable from the results of conventional toxicity tests , and to produce them in animals for study may require special ...
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