Services

Focused expert DMPK support at every stage, from early discovery and lead optimisation through to IND and Phase I. Mainly small molecules (with particular expertise in cannabinoids), but also oligonucleotides, ADCs and proteins/mAbs.

Lead optimisation and early de-risking

Early studies and strategy to steer away from known development red flags:

• DDI risk, MIST alerts and hiDILI potential
• Metabolic clearance (CLint) and metabolic pathways
• Plasma and blood protein binding (fu)
• CYP, other drug-metabolising enzyme and transporter interactions
• Early IVIVE and human dose prediction
• Clearance mechanism assessment using ECCS

IND and CTA-enabling studies

• Comprehensive in vitro DDI assessment in line with ICH M12
• Biotransformation, metabolite identification and pathways
• Pharmacokinetics and toxicokinetics, including NCA (Phoenix WinNonlin)
• GLP bioanalytical method development for TK
• Radiolabelled ADME studies

Regulatory support and study management

• Authoring nonclinical regulatory documents: IND Modules 2.6.4/2.6.5, Investigator’s Brochures, CTAs and briefing books
• CRO selection, study placement and study management
• Data review, gap analysis and interpretation

Custom radiosynthesis

• Advice on specialist radiosynthesis providers
• The best position and isotope (¹⁴C or ³H) for radiolabelling
• Study designs that make the most of valuable labelled material

How we can work together

• Embedded support: I join your team and take ownership of the DMPK work on a project.
• Ad hoc consultancy: expert advice by the hour, when you need it.