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 ix
... least one instance where it has taken more than seventeen years . In part , this disappointing trend is attributable to an increased demand for information on the safety and efficacy of a compound before it can be registered for sale ...
... least one instance where it has taken more than seventeen years . In part , this disappointing trend is attributable to an increased demand for information on the safety and efficacy of a compound before it can be registered for sale ...
Page 14
... least in general terms , by the Department of Health in the UK , by the European Drug Regulatory Authorities and by the FDA . The regulatory agencies also require for review suitable pharmacological - pharmacodynamic information about ...
... least in general terms , by the Department of Health in the UK , by the European Drug Regulatory Authorities and by the FDA . The regulatory agencies also require for review suitable pharmacological - pharmacodynamic information about ...
Page 26
... least , in a change in the relative proportions of metabolites as compared with the low dose situation . High dose exposure may also lead to non - linear pharmacokinetics ( i.e. AUC does not increase in proportion to drug dose ) , which ...
... least , in a change in the relative proportions of metabolites as compared with the low dose situation . High dose exposure may also lead to non - linear pharmacokinetics ( i.e. AUC does not increase in proportion to drug dose ) , which ...
Page 41
... least 14 days ) ; mutagenicity testing ( at least an Ames test ) . ( 2 ) To cover several doses , and perhaps treatment of patients for up to 7-10 days : experiments listed above ; subacute tests in two species involving dosing for 30 ...
... least 14 days ) ; mutagenicity testing ( at least an Ames test ) . ( 2 ) To cover several doses , and perhaps treatment of patients for up to 7-10 days : experiments listed above ; subacute tests in two species involving dosing for 30 ...
Page 43
... least of blood pressure and heart rate ( and perhaps of cardiac output ) , regional flow and dynamics to the new substance before and during administration of standard agonists and antagon- ists , and on stimulation of autonomic ...
... least of blood pressure and heart rate ( and perhaps of cardiac output ) , regional flow and dynamics to the new substance before and during administration of standard agonists and antagon- ists , and on stimulation of autonomic ...
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