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 37
... risk ratio of a new therapeutic agent which can be compared with similar ratios for already established drugs . REFERENCES Ariens , E. J. ( 1966 ) . Receptor theory and structure - action relationships . Adv . Drug Res . , 3 , 235-85 ...
... risk ratio of a new therapeutic agent which can be compared with similar ratios for already established drugs . REFERENCES Ariens , E. J. ( 1966 ) . Receptor theory and structure - action relationships . Adv . Drug Res . , 3 , 235-85 ...
Page 39
... risks can be matched against anticipated benefits of treatment . All these points require amplification , but they represent the basic classes of information which toxicologists produce , and from which risk and safety in man can be ...
... risks can be matched against anticipated benefits of treatment . All these points require amplification , but they represent the basic classes of information which toxicologists produce , and from which risk and safety in man can be ...
Page 44
... risks in man and so underlie the ultimate risk - benefit analysis that determines the utility of a new medicine . By convention they are done in the rat and the dog ( or sometimes the primate ) to gain the advantages of our extensive ...
... risks in man and so underlie the ultimate risk - benefit analysis that determines the utility of a new medicine . By convention they are done in the rat and the dog ( or sometimes the primate ) to gain the advantages of our extensive ...
Page 47
... risk that the resulting toxicity may not be a good guide to man ( see Pharmacokinetics section of this book ; Timbrell , 1984 ; Suell and Mullock , 1987 ) . Studying at least basic evidence about absorption and disposition in chronic ...
... risk that the resulting toxicity may not be a good guide to man ( see Pharmacokinetics section of this book ; Timbrell , 1984 ; Suell and Mullock , 1987 ) . Studying at least basic evidence about absorption and disposition in chronic ...
Page 48
... risk of clinical toxicity , which must be matched against the anticipated value of treatment in making the ' cost- benefit ' analysis that determines whether development of the substance continues until it becomes a freely usable ...
... risk of clinical toxicity , which must be matched against the anticipated value of treatment in making the ' cost- benefit ' analysis that determines whether development of the substance continues until it becomes a freely usable ...
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 |
Other editions - View all
Common terms and phrases
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