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 20
... blood gas analysis following 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 ...
... blood gas analysis following 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 ...
Page 31
... blood flow within the specific tissues . Administration by inhalation results in the delivery of drug via both the oral and pulmonary routes , with most of the dose ( approximately 90 % ) being delivered orally . The intraperitoneal ...
... blood flow within the specific tissues . Administration by inhalation results in the delivery of drug via both the oral and pulmonary routes , with most of the dose ( approximately 90 % ) being delivered orally . The intraperitoneal ...
Page 32
... blood concentration , time at which the maximum blood concentration is achieved , area under the concen- tration - time curve , systemic clearance and terminal disposition half - life are important for a quantitative assessment of drug ...
... blood concentration , time at which the maximum blood concentration is achieved , area under the concen- tration - time curve , systemic clearance and terminal disposition half - life are important for a quantitative assessment of drug ...
Page 33
... blood cells ) , cellular components and tissues depends on the macromolecule involved in the binding and the drug , and has a major impact on the extent to which a drug is distributed , since the driving force for the distribution of ...
... blood cells ) , cellular components and tissues depends on the macromolecule involved in the binding and the drug , and has a major impact on the extent to which a drug is distributed , since the driving force for the distribution of ...
Page 42
... blood clotting cascade , although they may well be assessed in the subacute and chronic experiments . The general nature of these studies ( Zbinden and Gross , 1979 ) relies on the classical , instrumented , anaesthetised animal and ...
... blood clotting cascade , although they may well be assessed in the subacute and chronic experiments . The general nature of these studies ( Zbinden and Gross , 1979 ) relies on the classical , instrumented , anaesthetised animal 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