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
Results 1-5 of 87
Page 3
... administration is beyond the scope of this chapter . An overview of critical pharmaceutical considerations for dosage forms generally developed for preclinical and early human testing will be covered . BACKGROUND The discovery phase of ...
... administration is beyond the scope of this chapter . An overview of critical pharmaceutical considerations for dosage forms generally developed for preclinical and early human testing will be covered . BACKGROUND The discovery phase of ...
Page 4
... administration . For 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 ...
... administration . For 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 ...
Page 6
... administration of high concentrations of doses of formulations for preclinical safety testing in animals is usually required for early stages , solution or suspension formulations of drug are often developed for toxicolo- gical testing ...
... administration of high concentrations of doses of formulations for preclinical safety testing in animals is usually required for early stages , solution or suspension formulations of drug are often developed for toxicolo- gical testing ...
Page 8
... administration play an important role in governing the overall biological performance of drugs . Some of the important parameters influencing the biological performance are the absorption and transport processes across biological ...
... administration play an important role in governing the overall biological performance of drugs . Some of the important parameters influencing the biological performance are the absorption and transport processes across biological ...
Page 11
... Administration has stated that in vivo bioequivalency studies for drugs with bioavailability problems will be required whenever changes in formulation or manufacturing site occur ( Dighe , 1988 ) . Because of limitations in aqueous ...
... Administration has stated that in vivo bioequivalency studies for drugs with bioavailability problems will be required whenever changes in formulation or manufacturing site occur ( Dighe , 1988 ) . Because of limitations in aqueous ...
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