Defining a full-service ADME data package: mass balance, quantitative whole body autoradiography (QWBA), metabolite profiling and metabolite identification
Animal and human studies that determine Absorption, Distribution, Metabolism and Excretion (ADME) characteristics of drug candidates are an integral part of the Drug Metabolism and Pharmacokinetics (DMPK) services provided by QPS (DE, USA). DMPK projects manage drug development programs from Discovery, Candidate Selection and Investigational New Drug (IND) Application, through to New Drug Application (NDA) stages. QPS supports a whole range of studies including radiolabeled mass balance studies, comprehensive biotransformation and quantitative whole-body autoradiography (QWBA) studies. Completion of these preclinical DMPK studies, coupled with clinical PK, will provide an ADME data package that will fully support a range of regulatory submissions (IND and NDA).
What will you learn?
- Gain a broader understanding of the excretion pathways derived from mass balance data and how that information may influence the design of future clinical studies.
- Learn how QWBA tissue distribution data informs your potential human Absorption, Metabolism and Excretion (hAME) study.
- Understand how metabolite profiling and metabolite identification provides coverage of potential human metabolites in safety studies.
Who may this interest?
- Scientists
- Laboratory scientists
- DMPK scientists
- QWBA scientists
- PK/PD scientists
Speakers
Group Leader – DMPK (In Vivo)
QPS, LLC (DE, USA)
Deborah Watson joined QPS, LLC in 2015 and is currently serving as a Group Leader of the In Vivo Group in the DMPK Department. In this position, Deb serves as Manager of the In Vivo Group, which is responsible for rat and mouse dosing, sample collection, and analysis for all non-radiolabeled pharmacokinetic/excretion and radiolabeled mass balance, pharmacokinetics, whole body autoradiography and microautoradiography studies performed in DMPK. Deb received her BA in Psychology and her PhD in Psychology (Behavioral Neuroscience) from the University of Delaware (DE, USA). Prior to joining QPS, Deb held Postdoctoral Fellow position at the University of Texas at Austin (TX, USA).
Biotransformation Group Leader
QPS, LLC (DE, USA)
Diane Grotz joined QPS, LLC in 2018 and is currently serving as Biotransformation Group Leader, in the DMPK department. In this position, Diane serves as manager of the biotransformation group, which performs metabolite profiling for in vitro, and preclinical and clinical in vivo studies. Prior to joining QPS, Diane focused on metabolite profiling as an Associate Principal Scientist at Merck (NJ, USA), and as a Senior Scientist at Schering-Plough (NJ, USA) supporting multiple therapeutic areas; also serving as Principal Investigator for discovery therapeutic teams, including responsibility for DMPK research. Diane received her Bachelors degree in Chemistry from Rutgers University in New Jersey, USA.
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