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 87
Page 8
... factors influencing the gastrointestinal process for drug absorp- tion and transport . These factors involve consideration from biological and physicochemical perspectives . Table 1.3 shows some of the important biological ...
... factors influencing the gastrointestinal process for drug absorp- tion and transport . These factors involve consideration from biological and physicochemical perspectives . Table 1.3 shows some of the important biological ...
Page 11
... factors in governing the flux across biological membranes , it is the combination of solubility and partition coefficient that influences the absorption and trans- port processes . It can be shown that biological activity may be ...
... factors in governing the flux across biological membranes , it is the combination of solubility and partition coefficient that influences the absorption and trans- port processes . It can be shown that biological activity may be ...
Page 12
... factors may be regarded as critical pharmaceutical considerations for successful formulation design and develop- ment . A thorough understanding and comparison of these by pharmaceutical scientists , medicinal chemists , biologists ...
... factors may be regarded as critical pharmaceutical considerations for successful formulation design and develop- ment . A thorough understanding and comparison of these by pharmaceutical scientists , medicinal chemists , biologists ...
Page 25
... factors are now known to influence the disposition of drugs in the same individual or population ( Bousquet , 1970 ; Smith , 1988 ) . Early position papers ( Drug Research Board , 1969 ) and regulatory state- ments ( World Health ...
... factors are now known to influence the disposition of drugs in the same individual or population ( Bousquet , 1970 ; Smith , 1988 ) . Early position papers ( Drug Research Board , 1969 ) and regulatory state- ments ( World Health ...
Page 27
... factors . As a consequence , it is critical to control these factors in disposition studies and , where appropriate , study their effects . A brief description of the preclinical drug disposition studies that may be relevant to the ...
... factors . As a consequence , it is critical to control these factors in disposition studies and , where appropriate , study their effects . A brief description of the preclinical drug disposition studies that may be relevant to the ...
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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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