Book ChapterDOI
Pharmaceutical Development in CTD
Sarfaraz K. Niazi
- pp 1481-1484
About:
The article was published on 2016-04-19. It has received 846 citations till now. The article focuses on the topics: CTD.read more
Citations
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Review: Toxicometabolomics: Toxicometabolomics
TL;DR: The current state of metabolomics technologies and principles, their uses in toxicology and the prospects for further metabolomics application also in a regulatory context are summarized.
Journal ArticleDOI
A specific, accurate, and sensitive measure of total plasma malondialdehyde by HPLC
TL;DR: This research demonstrates the inaccuracy that is inherent in plasma TBARS assays, which claim to quantify MDA, and it is proposed that the TBARS approach may limit the likelihood of detecting true differences in the level of lipid peroxidation in clinical studies.
Journal ArticleDOI
UPLC versus HPLC on Drug Analysis: Advantageous, Applications and Their Validation Parameters
TL;DR: The advantages of short turnaround time, method reliability, method sensitivity, and drug specificity justify the use of LC techniques for various groups of the drug active compounds.
Journal ArticleDOI
A validated high performance liquid chromatography method for the analysis of thymol and carvacrol in Thymus vulgaris L. volatile oil
TL;DR: A validated and reliable high performance liquid chromatography (HPLC) method has been developed for the analysis of these two components in T. vulgaris essential oil and they showed good agreement.
Journal ArticleDOI
Optimization of the GC method for routine analysis of the fatty acid profile in several food samples
TL;DR: In this paper, the fatty acids profile of food samples was determined by gas chromatography (GC) and the fat was extracted from different food samples using Soxhlet technique using methanolic solution of potassium hydroxide (transesterification).
References
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Journal ArticleDOI
Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies
Vinod P. Shah,Kamal K. Midha,Shrikant Dighe,Iain J. McGilveray,Jerome P. Skelly,Avraham Yacobi,Thomas Layloff,C. T. Viswanathan,C. Edgar Cook,R. D. McDowall,Kenneth A. Pittman,Sidney Spector +11 more
TL;DR: The report presents the assessment of the major agreements and issues discussed at the conference on analytical methods validation and provides guiding principles for validation of analytical methods used in bioavailability, bioequivalence, and pharmacokinetics studies in humans and animals.