DMPK Consulting
Professional Consulting for Drug Metabolism and Pharmacokinetics
Guy Webber, BSC, MSc (Dist): UK-based Senior Director for DMPK with 30 years experience in drug development with both Pharma/Biotech and CROs: ICON Plc, Evotec, GSK, Quotient Bioresearch (now Pharmaron), Covance (now Labcorp), GW Pharmaceuticals (now Jazz Pharma) with contributions to multiple successful NDAs
Lead Optimisation
Early studies to assess:
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Metabolic clearance (CLint) and metabolic pathways
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Plasma/blood protein binding (Fu)
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Early dose2man (IVIVE/C) estimation
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De-risk away from known development red flags (DDI risks, MIST alerts and DILI potential)​​
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CYP/other DME/Transporter interactions
IND Pathway
Regulatory Support
Studies to assess:
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Pharmacokinetics and toxicokinetics
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Comprehensive in vitro DDI assessment in compliance with ICH M12 guidance(s)
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GLP Bioanalytical method development (required for TK)​​​
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Radiolabelled ADME studies
​Regulatory support:
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Data/gap fill review
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CRO overview and manangment
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Authoring of nonclinical regulatory documents including BB, IND (sec 2.6.4/5), CTA, IBs.​​​
+ CRO selection, study placement, monitoring and management
+ Custom radiosynthesis (14C/3H) advice to maximise DMPK application
Contact: Guy.webber@dmpkservices.com
DMPK Consulting Services, Northampton, UK
Registered UK company.