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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Results 1-5 of 89
Page vi
... Heart Failure 313 J. E. Rush and M. Jessup 26 . Antithrombotic and Thrombolytic Drugs 326 J. Ritter 27. Monitoring of Antithrombotic Activity by Platelet Labelling H. Sinzinger and P. Fitscha 337 VI . Assessment of Drug Effects on the ...
... Heart Failure 313 J. E. Rush and M. Jessup 26 . Antithrombotic and Thrombolytic Drugs 326 J. Ritter 27. Monitoring of Antithrombotic Activity by Platelet Labelling H. Sinzinger and P. Fitscha 337 VI . Assessment of Drug Effects on the ...
Page 18
... heart rate and systemic arterial blood pressure , in both anaesthetised and conscious laboratory animals . Thus , a routine choice is to study the cardiovascular actions of these agents in both anaesthetised and conscious rats and dogs ...
... heart rate and systemic arterial blood pressure , in both anaesthetised and conscious laboratory animals . Thus , a routine choice is to study the cardiovascular actions of these agents in both anaesthetised and conscious rats and dogs ...
Page 19
... heart or other organs in vitro , in order to establish the mechanism underlying such a response . Some of the additional studies that may be conducted are outlined below . Central Nervous System A few pharmaceutical companies consider ...
... heart or other organs in vitro , in order to establish the mechanism underlying such a response . Some of the additional studies that may be conducted are outlined below . Central Nervous System A few pharmaceutical companies consider ...
Page 23
... heart : a model for assessement of antifibrillatory action of antiarrhythmic agents . Cardiovascular Res . , 12 , 212-20 Payne , A. N. , Garland , L. G. , Lees , I. W. and Salmon , J. A. ( 1988 ) . Selective inhibition of arachidonate 5 ...
... heart : a model for assessement of antifibrillatory action of antiarrhythmic agents . Cardiovascular Res . , 12 , 212-20 Payne , A. N. , Garland , L. G. , Lees , I. W. and Salmon , J. A. ( 1988 ) . Selective inhibition of arachidonate 5 ...
Page 42
... heart rate in anaesthetised animals induced by the substance , and in response to stimula- tion of the vagus and sympathetic nerve trunks , and on administration of typical adrenergic , cholinergic and histaminergic agonists and ...
... heart rate in anaesthetised animals induced by the substance , and in response to stimula- tion of the vagus and sympathetic nerve trunks , and on administration of typical adrenergic , cholinergic and histaminergic agonists and ...
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