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 6-10 of 87
Page 12
... administration considerations . These considerations have significant impact on the biological performance of drugs by governing transport across biological barriers . A combination of these factors may be regarded as critical ...
... administration considerations . These considerations have significant impact on the biological performance of drugs by governing transport across biological barriers . A combination of these factors may be regarded as critical ...
Page 14
... Administration ( FDA ) for the Investigation of a New Drug ( IND ) . At a later stage , a Marketing Authorisation Application ( MAA ; previously known as a Product Licence Application ) and a New Drug Application ( NDA ) are submitted ...
... Administration ( FDA ) for the Investigation of a New Drug ( IND ) . At a later stage , a Marketing Authorisation Application ( MAA ; previously known as a Product Licence Application ) and a New Drug Application ( NDA ) are submitted ...
Page 20
... administration of the NCE to the rat or other species is reported in the submission . Gastrointestinal System The effects of new compounds on gastric acid secretion in anaesthetised rats or specific measurements of gastrointestinal ...
... administration of the NCE to the rat or other species is reported in the submission . Gastrointestinal System The effects of new compounds on gastric acid secretion in anaesthetised rats or specific measurements of gastrointestinal ...
Page 21
... administration of the NCE can also be determined ( Allan et al . , 1985 ) . The effects on other haematological parameters are usually conducted as part of the toxicological investigation . Drug Interactions The regulatory agencies ...
... administration of the NCE can also be determined ( Allan et al . , 1985 ) . The effects on other haematological parameters are usually conducted as part of the toxicological investigation . Drug Interactions The regulatory agencies ...
Page 26
... administration may reveal the toxic potential of drugs , particularly affected target organs , it is very difficult to use the results of such studies for safety assessment when therapeutic doses result in exposure that may be many ...
... administration may reveal the toxic potential of drugs , particularly affected target organs , it is very difficult to use the results of such studies for safety assessment when therapeutic doses result in exposure that may be many ...
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