Suzanne L. Iverson, Dennis A. Smith's Metabolite Safety in Drug Development PDF

By Suzanne L. Iverson, Dennis A. Smith

ISBN-10: 111894965X

ISBN-13: 9781118949658

A reference on drug metabolism and metabolite security within the improvement section, this ebook studies the analytical ideas and experimental designs serious for metabolite stories. It gains case stories of classes discovered and actual global examples, besides regulatory views from the united states FDA and EMA.

•    Reviews the analytical thoughts and experimental designs serious for metabolite studies
•    Covers equipment together with chirality, species modifications, mass spectrometry, radiolabels, and in vitro / in vivo correlation
•    Discusses goal pharmacology, in vitro platforms aligned to toxicity assessments, and drug-drug interactions
•    Includes views from authors with firsthand involvement in and the learn of drug metabolites, together with viewpoints that experience stimulated regulatory instructions

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Example text

Solid probe spectra were also obtained to aid spectral elucidation. Where needed trimethylsilyl (TMS) ether derivatives were also prepared, using on‐column synthetic techniques. Similar exhaustive methods were employed for isolation of rat metabolites. Interpretation of electron impact mass spectra facilitated final deduction of metabolite structures, verifying N‐ and O‐dealkylation, and combinations thereof, as the major biotransformation routes in both species. Total radioactive excretion and measurement of plasma levels were also conducted through radiochemical assay.

Perkins, and L. A. Shipley. Drug metabolites in safety testing. Toxicol. Appl. , 2002, 182, 188–196. A. P. Beresford, D. McGibney, M. J. Humphrey, P. V. Macrae, and D. A. Stopher. Metabolism and kinetics of amlodipine in man. Xenobiotica, 1998, 18, 245–254. P. A. Bond. Metabolism of propranolol (“Inderal”), a potent, specific β‐adrenergic receptor blocking agent. Nature, 1967, 213, 721. E. Boyland. The correlation of experimental carcinogenesis and cancer in man. Prog. Exp. , 1969, 11, 222–223.

2 Decision tree from the draft FDA MIST guidance document. species or even direct administration of the metabolite(s) to animals. The draft guidance defined metabolites of interest as “unique” or “major” and interestingly argued that all metabolites accounting for >10% of the total drug‐related material (either administered dose or systemic exposure (whichever is the lower)) that were not present at sufficient levels in animals to underwrite safety should be subject to additional investigations.

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Metabolite Safety in Drug Development by Suzanne L. Iverson, Dennis A. Smith

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