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
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Page x
... conduct the large - scale clinical trial programmes needed before registration for sale of a new drug . However , there has not previously been available a single comprehensive volume which deals with the critical early phases of drug ...
... conduct the large - scale clinical trial programmes needed before registration for sale of a new drug . However , there has not previously been available a single comprehensive volume which deals with the critical early phases of drug ...
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... conducted on a new chemical entity ( NCE ) to support the application for an CTX / IND or an MAA / NDA are not defined precisely by the regulatory authorities . Although most readers are probably familiar with the above abbreviations ...
... conducted on a new chemical entity ( NCE ) to support the application for an CTX / IND or an MAA / NDA are not defined precisely by the regulatory authorities . Although most readers are probably familiar with the above abbreviations ...
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... conducted as part of the toxicological submission package and such studies must be conducted according to good laboratory practice ( GLP ) procedures . As will be discussed later , there are different opinions as to whether the ...
... conducted as part of the toxicological submission package and such studies must be conducted according to good laboratory practice ( GLP ) procedures . As will be discussed later , there are different opinions as to whether the ...
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... conducted within the same series of experiments . When submitting data to the European authorities at the MAA stage ... conducting the secondary pharmacological tests could be to explore whether the NCE has other potential clinical ...
... conducted within the same series of experiments . When submitting data to the European authorities at the MAA stage ... conducting the secondary pharmacological tests could be to explore whether the NCE has other potential clinical ...
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... conducted for the secondary pharma- cological evaluation will , to some extent , depend on the research philosophy ... conduct selected experiments considered appropriate to these needs . Good scientific judgement is therefore required ...
... conducted for the secondary pharma- cological evaluation will , to some extent , depend on the research philosophy ... conduct selected experiments considered appropriate to these needs . Good scientific judgement is therefore required ...
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