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 vi
... Platelet Labelling H. Sinzinger and P. Fitscha 337 VI . Assessment of Drug Effects on the Respiratory System 349 28 . Assessment of Respiratory Responses 351 T. W. Evans and P. J. Barnes 29. Anti - asthmatic Drugs 362 A. M. Edwards VII ...
... Platelet Labelling H. Sinzinger and P. Fitscha 337 VI . Assessment of Drug Effects on the Respiratory System 349 28 . Assessment of Respiratory Responses 351 T. W. Evans and P. J. Barnes 29. Anti - asthmatic Drugs 362 A. M. Edwards VII ...
Page 21
... Platelet Function If appropriate , the activity of the NCE on human platelet aggregation can readily be assessed in vitro ( Born , 1962 ; Whittle , 1987 ) and such an evaluation may provide useful preclinical information . Studies on ...
... Platelet Function If appropriate , the activity of the NCE on human platelet aggregation can readily be assessed in vitro ( Born , 1962 ; Whittle , 1987 ) and such an evaluation may provide useful preclinical information . Studies on ...
Page 22
... platelet actions of 9ẞ - methyl carbacyclin ( ciprostene ) , a chemically stable analogue of prostacyclin , in the ... platelets by adenosine diphosphate and its reversal . Nature , Lond . , 194 , 927–9 Cambridge , D. , Whiting , M. V. ...
... platelet actions of 9ẞ - methyl carbacyclin ( ciprostene ) , a chemically stable analogue of prostacyclin , in the ... platelets by adenosine diphosphate and its reversal . Nature , Lond . , 194 , 927–9 Cambridge , D. , Whiting , M. V. ...
Page 46
... platelet count and comments on a stained smear . Such tests as the prothrombin time and the accelerated partial thrombo- plastin time can readily be incorporated as broad indicators of the clotting cascade . These observations are best ...
... platelet count and comments on a stained smear . Such tests as the prothrombin time and the accelerated partial thrombo- plastin time can readily be incorporated as broad indicators of the clotting cascade . These observations are best ...
Page 221
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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