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 85
Page 3
... therapeutic indication ( s ) . Introduction of new drugs either could be in the form of new chemical entities , or from regulatory perspectives a drug might be considered ' new ' because of changes in its composition , route of adminis ...
... therapeutic indication ( s ) . Introduction of new drugs either could be in the form of new chemical entities , or from regulatory perspectives a drug might be considered ' new ' because of changes in its composition , route of adminis ...
Page 4
... therapeutic or pharmacological promise through animal models or in vitro techniques during initial screening , it must undergo preclinical safety , pharmacokinetics or biopharmaceutics testing , followed by extensive generation of other ...
... therapeutic or pharmacological promise through animal models or in vitro techniques during initial screening , it must undergo preclinical safety , pharmacokinetics or biopharmaceutics testing , followed by extensive generation of other ...
Page 12
... therapeutic dose may suffice , but inadequate bioavailabil- ity may result for a drug with similar solubility which requires a therapeutic dose of several hundred milligrams . Similarly , a highly lipophilic drug may have low ...
... therapeutic dose may suffice , but inadequate bioavailabil- ity may result for a drug with similar solubility which requires a therapeutic dose of several hundred milligrams . Similarly , a highly lipophilic drug may have low ...
Page 14
... agents as therapeutic drugs , but a similar approach should be adopted for potential chemotherapeutic agents such as antiviral , antican- cer or anti - parasitic drugs . In addition , 14 2: The Pharmacological Background.
... agents as therapeutic drugs , but a similar approach should be adopted for potential chemotherapeutic agents such as antiviral , antican- cer or anti - parasitic drugs . In addition , 14 2: The Pharmacological Background.
Page 15
... therapeutic use ; ( 2 ) the secondary pharmacology , which should describe other relevant activities of the NCE . These secondary tests are sometimes referred to as the ' safety pharmacology evaluation ' but there is some concern about ...
... therapeutic use ; ( 2 ) the secondary pharmacology , which should describe other relevant activities of the NCE . These secondary tests are sometimes referred to as the ' safety pharmacology evaluation ' but there is some concern about ...
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