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Clinical Pharmacology

Maximising the value from your clinical studies

Seda Pharmaceutical Development Services’ Clinical Pharmacology expertise is unique in that it is fully integrated with our Pharmaceutical Development and Biopharmaceutics capability and is aimed at supporting drug product design alongside optimal use in the clinic. Seda’s Clinical Pharmacologists apply their deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), and pharmacology to input to appropriate clinical trial design, contributing to aspects such as start dose, dose escalations, PK sampling schedule, food effect and drug-drug interactions. This service links seamlessly with Biopharmaceutics modelling of drug exposure to enable product design, the development of clinically relevant dissolution tests, food effect and formulation bridging studies (bioequivalence).

Support we can provide includes:

  • First in Patient Clinical Study Design (Clinical Pharmacology perspectives)
    • Controlling risk to subjects
      • DDI: Understanding potential drug interactions ensures the safe use of candidate drugs in early clinical development through identification of appropriate restrictions (i.e. what other drugs the candidate drug can be co-dosed with).
      • Dose: Supporting starting dose selection and PK interpretation during dose escalation and cohort expansion
    • Ensuring the study design will meet the objectives
      • Exclusion and Inclusion Criteria: focused on patient characteristics that may affect PK exposure
      • PK-PD understanding to support choice of go forward dose
    • Technical writing of appropriate sections of Clinical Trial Application (CTA)
  • Modelling candidate drug exposure in humans and its relationship to safety and efficacy to recommend drug delivery system designs that will give the required exposure, recommend in vitro formulation performance characteristics necessary to ensure good performance in patients, and design dosing regimens to achieve optimal safety and efficacy in humans.

For drugs in the later stages of development, we can provide expert guidance on:

  • How to bridge the in vivo performance of early phase and later phase formulations, including pivotal
    clinical and commercial products (bioequivalence).
  • Clinical pharmacology studies required to support labelling requirements (such as drug-drug
    interaction studies) to enable marketing authorisation. This can include study design, data analysis
    and interpretation.
  • Technical authoring of NDA/MAA clinical summary sections “Biopharmaceutics and Associated
    Analytical Methods” and “Clinical Pharmacology Studies” and support for labelling.
  • Clinically relevant dissolution tests. They ensure, that during pivotal studies, the drug product will
    provide the necessary exposure in patients and provide reassurance to regulators facilitating greater
    regulatory flexibility and a more robust supply chain

Related Publication

Effect of multiple‐dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin

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Expertise:

  • DMPK Consultancy and Dose Selection
  • Pharmacokinetic Modelling
  • Complex Medicines
  • CMC Regulatory
  • Clinical Pharmacology
  • Analytical Sciences

Paul A Dickinson

BPharm (Hons) PhD

Chief Scientific Officer & Co-Founder

Paul A Dickinson

BPharm (Hons) PhD

Chief Scientific Officer & Co-Founder

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Paul has held several senior science leadership roles in Academia and Large Pharma.  These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pharmaceutical and clinical disciplines.

 

Immediately prior to founding Seda Pharmaceutical Development Services Paul was Senior Clinical Pharmacology Scientist at AstraZeneca and led the clinical pharmacology program to NDA/MAA for AZD9291/osimertinib, which had been awarded ‘breakthrough therapy’ status by the FDA.  Formerly Paul was a Principal Scientist within Pharmaceutical Development (AZ) leading both the global biopharmaceutics network and the Medicines Evaluation science community (USA, SE, UK).

 

Paul has been at the forefront of recent advances in the understanding of in vitro performance criteria that assure product performance in the patient including clinically relevant dissolution specifications (CRDS).  Paul has co-authored papers with FDA staff focussed on efforts to combine biopharmaceutics with ICH Q8 (BioRAM) and is past Chair of the AAPS ‘QbD and product performance’ focus group.

‪Paul A Dickinson‬ – ‪Google Scholar‬

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    Expertise:

    • Complex Medicines
    • Clinical Pharmacology

    Claire Patterson

    MPharm (Hons) PhD

    Director: Pharmaceutical Sciences

    Claire Patterson

    MPharm (Hons) PhD

    Director: Pharmaceutical Sciences

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    Claire Patterson is Senior Principal Scientist at Seda with a Master of Pharmacy (MPharm) and a Ph.D. in Pharmaceutics from the Universities of Nottingham and University College London respectively. Claire is an experienced Biopharmaceutics scientist having spent 12 years with former employer AstraZeneca with roles in Early and Late Stage Product Development, linking in vitro to in vivo product performance. Current focus areas include subcutaneous and complex parenteral biopharmaceutics (including nanomedicines) and other non-oral routes of administration.

    ‪Claire Patterson‬ – ‪Google Scholar‬

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      Expect a reply typically within 48 hours.

      Expertise:

      • Oral Drug Delivery
      • DMPK Consultancy and Dose Selection
      • Pharmacokinetic Modelling
      • Clinical Pharmacology

      Linette Ruston

      BSc (Hons) PhD

      Director: ADME and Modelling Sciences

      Linette Ruston

      BSc (Hons) PhD

      Director: ADME and Modelling Sciences

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      Linette is a Senior Principal Scientist at Seda with a BSc (Hons) and PhD in Chemistry from Universities of Glasgow and Edinburgh, respectively.  She is an experienced Biopharmaceutics and DMPK scientist having spent 17+ years with AstraZeneca where she held roles in Discovery and Early Pharmaceutical Development, providing expert physicochemical, ADME and Biopharmaceutics input into compound design and selection, and applied knowledge of in vitro, in silico and in vivo models to enable material choice and project progression from discovery to early clinical development.  Her current focus is on translation of DMPK/PD and biopharmaceutics understanding into meaningful product and clinical study design within Seda.

      Ask me a question

        Expect a reply typically within 48 hours.