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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 the optimal design of drug product alongside their 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: focussed 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 and Dose Selection
  • Pharmacokinetic Modelling
  • Complex Parenterals
  • Regulatory CMC
  • Clinical Pharmacology

Paul A Dickinson

BPharm (Hons) PhD

Director & Co-Founder

Paul A Dickinson

BPharm (Hons) PhD

Director & 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.

 

Ask me a question

    Expect a reply typically within 48 hours.

    Expertise:

    • Complex Parenterals
    • Pharmacokinetic Modelling
    • Clinical Pharmacology

    Claire Patterson

    MPharm (Hons) PhD

    Senior Principal Scientist

    Claire Patterson

    MPharm (Hons) PhD

    Senior Principal Scientist

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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.

    Ask me a question

      Expect a reply typically within 48 hours.

      Expertise:

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

      Wang Wang Lee

      MPharm (Hons) PhD GPhC

      Principal Scientist

      Wang Wang Lee

      MPharm (Hons) PhD GPhC

      Principal Scientist

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      Wang Wang Lee is a GPhC registered pharmacist with a PhD in Pharmaceutical Sciences and MBA from the University of Strathclyde. She has deep industry and academic experience particularly in the areas of biopharmaceutics and product development. Her expertise in early and late stage development, risk assessing and mitigating the development challenges has helped clients transition compounds into the clinic from discovery. Most recently, she is interested in DMPK and clinical pharmacology projects for poorly solubles and complex parenterals.

      Ask me a question

        Expect a reply typically within 48 hours.