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 v
... Practice and Quality Assurance B. Gennery 127 III . Ethical and Legal Considerations 137 12 . Ethical Aspects of Research in Healthy Volunteers S. J. Warrington 139 13. Ethical Aspects of Research in Patients F. Wells 14. Contents Table ...
... Practice and Quality Assurance B. Gennery 127 III . Ethical and Legal Considerations 137 12 . Ethical Aspects of Research in Healthy Volunteers S. J. Warrington 139 13. Ethical Aspects of Research in Patients F. Wells 14. Contents Table ...
Page 7
... require that the formulations for toxicology testing must be manufactured in accordance with good laboratory practices ( GLPs ) . BIOLOGICAL CONSIDERATIONS The ultimate goal in the drug design and The pharmaceutical background 7.
... require that the formulations for toxicology testing must be manufactured in accordance with good laboratory practices ( GLPs ) . BIOLOGICAL CONSIDERATIONS The ultimate goal in the drug design and The pharmaceutical background 7.
Page 15
... practice ( GLP ) procedures . As will be discussed later , there are different opinions as to whether the pharmacological studies need to be performed according to GLP procedures . A third section on ' drug interactions ' , when ...
... practice ( GLP ) procedures . As will be discussed later , there are different opinions as to whether the pharmacological studies need to be performed according to GLP procedures . A third section on ' drug interactions ' , when ...
Page 41
... Practice ( Department of Health and Social Security , 1986 ) . The purpose of these rules is to ensure that there is a clear , permanent record of the complete experimental protocols , of the source and nature of the materials used in ...
... Practice ( Department of Health and Social Security , 1986 ) . The purpose of these rules is to ensure that there is a clear , permanent record of the complete experimental protocols , of the source and nature of the materials used in ...
Page 43
... practice . This type of judgement can be difficult , and sometimes no more than a cautious prediction can be given about probable lack of effect in man , plus a recommendation for clinical monitoring of a particular activity . Acute ...
... practice . This type of judgement can be difficult , and sometimes no more than a cautious prediction can be given about probable lack of effect in man , plus a recommendation for clinical monitoring of a particular activity . Acute ...
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