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 4
... example , for solid dosage forms , stability of the drug in the solid state should be investigated in depth , while for solution formulations ( parenteral or oral ) , degradation and kinetics of solution stability may require critical ...
... example , for solid dosage forms , stability of the drug in the solid state should be investigated in depth , while for solution formulations ( parenteral or oral ) , degradation and kinetics of solution stability may require critical ...
Page 9
... example , for parenteral administration , especially via the intravenous route , drugs must be formulated in solution form . Solubility of the drug in a particular solvent or a mixed solvent system will determine the limitation within ...
... example , for parenteral administration , especially via the intravenous route , drugs must be formulated in solution form . Solubility of the drug in a particular solvent or a mixed solvent system will determine the limitation within ...
Page 10
... example , digitoxin , 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 ...
... example , digitoxin , 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 ...
Page 12
... example , an aqueous solubility of several micrograms / ml for a very potent drug requiring a few milligrams dose for therapeutic dose may suffice , but inadequate bioavailabil- ity may result for a drug with similar solubility which ...
... example , an aqueous solubility of several micrograms / ml for a very potent drug requiring a few milligrams dose for therapeutic dose may suffice , but inadequate bioavailabil- ity may result for a drug with similar solubility which ...
Page 15
... example , an antiviral or an antitumour agent , then the appropri- ate studies which support the primary activity for the proposed therapeutic utility of the compound should be reported . The authorities expect that the primary ...
... example , an antiviral or an antitumour agent , then the appropri- ate studies which support the primary activity for the proposed therapeutic utility of the compound should be reported . The authorities expect that the primary ...
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