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 90
Page x
... particular the clinical pharmacological methods which may be applied to assessment of drug safety and efficacy in ... particular important areas . We are grateful to many , but in particular to Professor Paul Turner who encouraged us to ...
... particular the clinical pharmacological methods which may be applied to assessment of drug safety and efficacy in ... particular important areas . We are grateful to many , but in particular to Professor Paul Turner who encouraged us to ...
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... particular solvent or a mixed solvent system will determine the limitation within which the drug may be formulated . Often , during the preclinical investigation phase , high concentrations or doses of drugs must be adminis- Table 1.4 ...
... particular solvent or a mixed solvent system will determine the limitation within which the drug may be formulated . Often , during the preclinical investigation phase , high concentrations or doses of drugs must be adminis- Table 1.4 ...
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... particular NCE , and this is one reason why the regulatory authorities cannot , and do not , define the precise studies which should be performed . The authorities do require appropriate validation of the experimental models and ...
... particular NCE , and this is one reason why the regulatory authorities cannot , and do not , define the precise studies which should be performed . The authorities do require appropriate validation of the experimental models and ...
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... particular series of experiments conducted for the secondary pharma- cological evaluation will , to some extent , depend on the research philosophy of the pharmaceutical house . An organisation which relies on random screening for ...
... particular series of experiments conducted for the secondary pharma- cological evaluation will , to some extent , depend on the research philosophy of the pharmaceutical house . An organisation which relies on random screening for ...
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... considered appropriate or necessary to define the actions of that particular NCE in these species . Respiratory System The effects of the NCE on bronchopulmonary parameters 18 Preliminaries to testing of drugs in man.
... considered appropriate or necessary to define the actions of that particular NCE in these species . Respiratory System The effects of the NCE on bronchopulmonary parameters 18 Preliminaries to testing of drugs in man.
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