Services
Our consultants have extensive experience across the entire drug discovery and development process. Either fully embedded as project team members (our preferred way of working), or providing distinct packages for problem-solving, strategy discussions, regulatory documentation or diligence, we work across all areas of Medicinal Chemistry/DMPK/ADME to help progress drug discovery/development projects with our expertise, experience and analysis.
We are available to help with your Medicinal Chemistry/DMPK/ADME needs, including:
Drug Discovery
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Guiding Chemistry with DMPK/ADME strategy to optimise chemical equity to balance potency with pharmacokinetic properties to select the best compound for clinical development.
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Design and implementation of in vitro and in vivo DMPK studies, including liaising with CROs to provide high quality DMPK data.
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Evaluation of in vivo PK information and assessment of in vitro to in vivo correlation.
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Understanding clearance pathways of potential candidates.
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Initial human PK and dose projection based on preclinical information.
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Providing initial victim and perpetrator drug-drug interaction assessments.
Preclinical Development
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Working with Safety to design dose regimens for non-GLP and GLP safety studies.
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Interpretation of toxicokinetics and potential safety margins.
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Evaluation of potential for DDI with respect to ICH M12 DDI guidance.
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Completing candidate PK Written Summary and DMPK input to Investigator Brochure.
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Providing DMPK input to first clinical study protocol.
Clinical Development to Regulatory Filing
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Formulating the IND to NDA strategy, including planning for human ADME study, fully understanding the metabolism profile of the drug and formulating the drug-drug interaction overview for Regulatory submission.
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Responding to any Regulatory queries on the DMPK/ADME aspects of a drug.
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Writing the PK Written Summary and other DMPK Regulatory documents for NDA submission.
Miscellaneous
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Contributing DMPK/ADME expertise to 3rd party due diligence.
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Providing DMPK training, lectures or mentoring as appropriate.
