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 3
... considered ' new ' because of changes in its composition , route of adminis- tration , recommended dosage or dosage form . This chapter will deal primari- ly with pharmaceutical considerations for development of new chemical entities ...
... considered ' new ' because of changes in its composition , route of adminis- tration , recommended dosage or dosage form . This chapter will deal primari- ly with pharmaceutical considerations for development of new chemical entities ...
Page 10
... griseofulvin , some steroids , indomethacin , chlorpropamide and other drugs with low solubility are considered to have large variation in biological availability . Recently , the US Food and Drug. 10 Preliminaries to testing of drugs in ...
... griseofulvin , some steroids , indomethacin , chlorpropamide and other drugs with low solubility are considered to have large variation in biological availability . Recently , the US Food and Drug. 10 Preliminaries to testing of drugs in ...
Page 12
... considered subpotent and may no longer produce the desired pharmacological response . Thus , chemical and physical stability of the drug substance in solid and solution state under a variety of environmental conditions , e.g. light ...
... considered subpotent and may no longer produce the desired pharmacological response . Thus , chemical and physical stability of the drug substance in solid and solution state under a variety of environmental conditions , e.g. light ...
Page 16
... considered . Indeed , there is a growing expectancy of the regulatory authorities that the pharmacological and phar- macodynamic studies should be linked closely to the pharmacokinetic evalua- tion , and , if possible , be conducted ...
... considered . Indeed , there is a growing expectancy of the regulatory authorities that the pharmacological and phar- macodynamic studies should be linked closely to the pharmacokinetic evalua- tion , and , if possible , be conducted ...
Page 17
... considered appropriate to these needs . Good scientific judgement is therefore required to decide on the nature and extent of these pharmacological studies . Thus , if the NCE which is to be used as an anti - inflammatory agent produces ...
... considered appropriate to these needs . Good scientific judgement is therefore required to decide on the nature and extent of these pharmacological studies . Thus , if the NCE which is to be used as an anti - inflammatory agent produces ...
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