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. |
From inside the book
Results 1-5 of 89
Page x
... allow a decision to be made to progress to the later , comprehensive , stages of drug development . Increasingly there is concern about the time delays in developing modern drugs and debate about ethical aspects of clinical trials ...
... allow a decision to be made to progress to the later , comprehensive , stages of drug development . Increasingly there is concern about the time delays in developing modern drugs and debate about ethical aspects of clinical trials ...
Page 26
... allow an assessment of the extent and duration of exposure to the drug and indicate whether metabolic patterns change with dosage . High dose exposure may saturate major metabolic pathways and result in alternative pathway metabolism or ...
... allow an assessment of the extent and duration of exposure to the drug and indicate whether metabolic patterns change with dosage . High dose exposure may saturate major metabolic pathways and result in alternative pathway metabolism or ...
Page 34
... allows an assessment of whether transplacental transfer of drug occurs and whether the drug is secreted into milk . Pigmented animal strains can also be used to evaluate binding to pigmented tissue . 14C - labelled drug is ideal for ...
... allows an assessment of whether transplacental transfer of drug occurs and whether the drug is secreted into milk . Pigmented animal strains can also be used to evaluate binding to pigmented tissue . 14C - labelled drug is ideal for ...
Page 37
... allow a biologically coherent evaluation of drug pharmacolo- gy and safety and to be of predictive value . The dosage and dosage regimen of the drug can then be appropriately adjusted to take into account interspecies differences in the ...
... allow a biologically coherent evaluation of drug pharmacolo- gy and safety and to be of predictive value . The dosage and dosage regimen of the drug can then be appropriately adjusted to take into account interspecies differences in the ...
Page 49
... allow for intercurrent death of animals . Interpreting the results requires care to avoid misleading impressions , e.g. the need to consider the background incidence of spontaneous tumours , the importance of distinguishing between a ...
... allow for intercurrent death of animals . Interpreting the results requires care to avoid misleading impressions , e.g. the need to consider the background incidence of spontaneous tumours , the importance of distinguishing between a ...
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 |
Other editions - View all
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