Simultaneous Quantitative and Qualitative Measurements in Drug-Metabolism Investigations
This article presents the successful analysis of metabolic products from microsomal incubations of a common pharmaceutical compound.
Simultaneous quantitative and qualitative collection of information from a drug-metabolism and pharmacokinetics analysis can increase productivity in drug discovery and development. These two data sets are traditionally collected from two parallel sample lines, run at differing concentrations, and often on separate liquid chromatography–tandem mass spectrometry (LC–MS/MS) instruments because of LC–MS technology. Most current LC–MS/MS systems offering the high mass accuracy required for metabolite identification lack the sensitivity and linear range to perform quantitative bioanalysis at therapeutic dosing levels.
This article presents the successful analysis of metabolic products from microsomal incubations of a common pharmaceutical compound. Using quadrupole time-of-flight mass spectrometry, the author obtained clearance data, metabolic identification, structural elucidation, and metabolic profiles from a single sample set.
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Pharmaceutical Technology’s 2013 Analytical and Bioanalytical Testing ebook.
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
Inspiration Over Desperation: Accurant Biotech CEO Talks Leadership, Innovation, and Motivation
March 4th 2025Xiao-Yan Cai, PhD, shares insights into her leadership style, the importance of motivation in the workplace, and how she balances repetition with innovation, discussing how hobbies and resilience uniquely shape her professional approach, emphasizing the value of perseverance and preparation in both science and life.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
