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 85
Page 15
... performed , they do provide guidance on the style and format for the reporting of the appropriate data . Each of the regulatory authorities requires presentation of the pharmacolo- gical properties of the NCE in two separate sections ...
... performed , they do provide guidance on the style and format for the reporting of the appropriate data . Each of the regulatory authorities requires presentation of the pharmacolo- gical properties of the NCE in two separate sections ...
Page 16
... performed . The authorities do require appropriate validation of the experimental models and technical procedures employed in the studies . It would , there- fore , be expedient to utilise procedures which are generally accepted by the ...
... performed . The authorities do require appropriate validation of the experimental models and technical procedures employed in the studies . It would , there- fore , be expedient to utilise procedures which are generally accepted by the ...
Page 17
... performed as part of the secondary pharmacology evaluation of Table 2.1 Secondary pharmacological evaluation of new chemical entities UK and Europe Central nervous system Autonomic system Cardiovascular system Respiratory system ...
... performed as part of the secondary pharmacology evaluation of Table 2.1 Secondary pharmacological evaluation of new chemical entities UK and Europe Central nervous system Autonomic system Cardiovascular system Respiratory system ...
Page 19
... performed in some pharmacological laboratories , although these experiments often reflect the research interests and expertise available in the individual companies . Alternatively , they may be performed in response to particular ...
... performed in some pharmacological laboratories , although these experiments often reflect the research interests and expertise available in the individual companies . Alternatively , they may be performed in response to particular ...
Page 67
... performed , with appropriate concern for the humane issues that are associated with it , it can provide valuable information about the biological and the toxicological properties of a new chemical entity . Testing for Systemic Toxicity ...
... performed , with appropriate concern for the humane issues that are associated with it , it can provide valuable information about the biological and the toxicological properties of a new chemical entity . Testing for Systemic Toxicity ...
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