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 93
Page vi
... Cardiovascular System 251 21. Non - invasive Measurement of Cardiovascular Response 253 J. D. Harry 22. Anti - anginal Drugs 265 E. Roland 23. Anti - arrhythmic Agents P. K. Marrott 288 24 . Phase I Trials on Anti - hypertensive Drugs ...
... Cardiovascular System 251 21. Non - invasive Measurement of Cardiovascular Response 253 J. D. Harry 22. Anti - anginal Drugs 265 E. Roland 23. Anti - arrhythmic Agents P. K. Marrott 288 24 . Phase I Trials on Anti - hypertensive Drugs ...
Page 17
... Cardiovascular system Respiratory system Gastrointestinal system Other systems where relevant USA Neuropharmacology Cardiovascular / respiratory Gastrointestinal Genitourinary Endocrine Anti - inflammatory Immunoactive Chemotherapeutic ...
... Cardiovascular system Respiratory system Gastrointestinal system Other systems where relevant USA Neuropharmacology Cardiovascular / respiratory Gastrointestinal Genitourinary Endocrine Anti - inflammatory Immunoactive Chemotherapeutic ...
Page 18
... Cardiovascular System The majority of pharmaceutical companies evaluate the cardiovascular profile of the NCE in some detail , including changes in heart rate and systemic arterial blood pressure , in both anaesthetised and conscious ...
... Cardiovascular System The majority of pharmaceutical companies evaluate the cardiovascular profile of the NCE in some detail , including changes in heart rate and systemic arterial blood pressure , in both anaesthetised and conscious ...
Page 19
... cardiovascular actions of the NCE . Gastrointestinal System As an overall index of gastrointestinal motility , most pharmaceutical com- panies investigate the effect of the NCE on the transit of a polyvinyl chloride or charcoal meal or ...
... cardiovascular actions of the NCE . Gastrointestinal System As an overall index of gastrointestinal motility , most pharmaceutical com- panies investigate the effect of the NCE on the transit of a polyvinyl chloride or charcoal meal or ...
Page 20
... Cardiovascular System The most pertinent cardiovascular studies will have been conducted as part of the core package . In addition , the arrhythmogenic or antiarrhythmic activity of the NCE may be determined in mouse , rat , cat or dog ...
... Cardiovascular System The most pertinent cardiovascular studies will have been conducted as part of the core package . In addition , the arrhythmogenic or antiarrhythmic activity of the NCE may be determined in mouse , rat , cat or dog ...
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