Diversity and inclusion in the bioanalytical industry: an interview with Shefali R Patel.

Shefali R Patel speaks to Sankeetha Nadarajah, Commissioning Editor.

Bioanalytical challenges and strategies for accurately measuring acyl glucuronide metabolites in biological fluids.

Bioanalysis of unstable compounds such as acyl glucuronide metabolites represents a great analytical challenge owing to poor analyte stability in biological matrices. The primary goal for bioanalytical assay development is to minimize the breakdown of acyl glucuronide metabolite into its parent aglycone during sample collection, transportation, storage and analysis. Samples need to be stabilized ex vivo immediately after sample collection to minimize potential breakdown and thus to ensure accurate concentration measurement of both acyl glucuronide metabolite and its parent aglycone. In this review paper, formation of acyl glucuronide metabolites, the importance of establishing acyl glucuronide exposure measurement and safety coverage, optimization of sample pretreatment to stabilize the acyl glucuronide metabolites, current analytical strategy of assaying them as well as considerations for regulatory filings are discussed. It is important to identify acyl glucuronide metabolites that are capable of undergoing hydrolysis and pH-dependent intra-molecular migration as well as covalently binding to plasma and tissue proteins which can cause toxicity in vivo in the early stages of drug development. Carefully planning analytical experiments, identifying structures of acyl glucuronides and monitoring their concentrations in early drug development can help assess the risks associated with their exposures and potentially predict their concentrations in human circulation.

Microsampling for quantitative bioanalysis, an industry update: output from an AAPS/EBF survey.

There is continuing interest in the development and application of various microsampling technologies for drug development. The AAPS bioanalytical community microsampling subgroup and the European Bioanalysis Forum conducted a survey of their members (39 individual organizations). This gives a snapshot of current practices and demonstrates that implementation of microsampling approaches is becoming increasingly commonplace, but not universal. Greater adoption was observed for nonclinical studies, particularly nonregulatory. A number of respondents reported that they have included microsampling data in regulatory submissions. Another important observation was that where microsampling is employed for clinical studies, dried blood approaches predominate, reflecting the interest in their use where they enable sample collection which is not feasible with standard approaches or to derive richer data sets.

Perspectives on gender parity in bioanalysis: an interview with Shefali Patel.

Biography Shefali R Patel is a Senior Scientist and a Group leader in the Bioanalytical Group within DMPK Department at Janssen (a Johnson & Johnson company). In her current role, she is supervising the nonregulated bioanalysis group within East Coast Bioanalytical Department. Also, as a part of her current role, she is applying microsampling techniques for rodent studies within Johnson & Johnson. She has 17 years of experience in Bioanalytical Sciences. Before joining Janssen in 2007, Shefali was a Research Chemist with Drug Metabolism Department for Merck Research Laboratories in Rahway, NJ, USA. Prior to Merck, she was employed as Scientist with Taylor Technology (CRO) in Princeton, NJ, USA.