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 74
Page 13
... plasma . Bull . Parenteral Drug Ass . , 28 , 1-14 Sinkula , A. A. , Morozowich , W. and Rowe , E. L. ( 1973 ) . Chemical modification of clindamycin : synthesis and evaluation of selected esters . J. Pharm . Sci . , 62 , 1106 Wang ...
... plasma . Bull . Parenteral Drug Ass . , 28 , 1-14 Sinkula , A. A. , Morozowich , W. and Rowe , E. L. ( 1973 ) . Chemical modification of clindamycin : synthesis and evaluation of selected esters . J. Pharm . Sci . , 62 , 1106 Wang ...
Page 25
... Across - species assessments of exposure to drugs and their metabolites is best made on the basis of quantitative pharmacokinetic parameters such as maximum plasma concentration 25 The Metabolic Background 3: The Metabolic Background.
... Across - species assessments of exposure to drugs and their metabolites is best made on the basis of quantitative pharmacokinetic parameters such as maximum plasma concentration 25 The Metabolic Background 3: The Metabolic Background.
Page 26
... plasma concentration , area under plasma concentration - time curve ( AUC ) , systemic clearance and terminal disposition half - life . These data allow an assessment of the extent and duration of exposure to the drug and indicate ...
... plasma concentration , area under plasma concentration - time curve ( AUC ) , systemic clearance and terminal disposition half - life . These data allow an assessment of the extent and duration of exposure to the drug and indicate ...
Page 33
... plasma proteins and red blood cells ) , cellular components and tissues depends on the macromolecule involved in the binding and the drug , and has a major impact on the extent to which a drug is distributed , since the driving force ...
... plasma proteins and red blood cells ) , cellular components and tissues depends on the macromolecule involved in the binding and the drug , and has a major impact on the extent to which a drug is distributed , since the driving force ...
Page 36
... plasma - protein binding and pKa of the drug or its metabolites . Thus , the biotransformation of lipophilic drugs to polar metabolites enhances renal excretion . For drugs having a pK2 near the pH of urine , the rate of excretion can ...
... plasma - protein binding and pKa of the drug or its metabolites . Thus , the biotransformation of lipophilic drugs to polar metabolites enhances renal excretion . For drugs having a pK2 near the pH of urine , the rate of excretion can ...
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 |
Other editions - View all
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