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.
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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.
