About
ADME
Non-clinical DMPK

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Early career in the laboratory performing bioanalysis, PK analysis and ADME screening assays for drug discovery.

Clinical Pharmacology

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Experienced in drug development across all clinical study phases including First-in-Human SAD/MAD, Drug-Drug Interaction, Thorough QTc studies and more.

Pharmacometric

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Hands-on pharmacometrician using various modelling tools to support and de-risk different stages of drug development including in vitro to in vivo extrapolation, exposure-response analysis and more.

Expert in PBPK modelling complimented by ADME experience.

Regulatory
Interactions

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Global drug applications support for USA, EU, UK, Japan, China, Switzerland, Australia and more.

Find out more

Why us

With a team that is spread across US, UK, France and Japan, we have the right people to support you globally

Services

Home
Clinical Pharmacology Support
  • Clinical study design
  • Gap analysis
  • Clinical pharmacology strategy plan
  • Pharmacokinetics analysis
Modelling and Simulations
  • Human dose predictions
  • Dose Optimisation
  • Paediatric dose extrapolation
Home
Regulatory
  • Clinical study design protocol
  • Drug application - Clinical pharmacology module
  • Drug labelling

 How we can help

Wherever you are in your drug development, we have experience from pre-clinical through to market application and beyond. Take a look at the case studies.

Case studies

Frequently Asked Questions

We only have data from Phase 1 clinical trial. Can you help with Phase 2 dose selection?
Certainly. Using the rich data from Phase 1, we are able to model the PK profile of your drug out to steady-state, leveraging clinical or non-clinical PD data to predict efficacious dose. Furthermore, we can explore internal and external factors, for example, bodyweight, age, gender, polymorphism, food effect etc., that may influence PK across the population and guide dosing.
How will modelling help me?
Modelling is not just about describing your PK data mathematically, but can be used to extract hidden information from your dataset. It can even be used to increase your existing dataset by generating additional PK data.
I have a PBPK model that suggest potent drug-drug interaction, but did not translate into clinic. Why is that?
There could be various reasons for disconnect between models and observed data. Models are only as good as the available data and often heavily relies on assumptions. Depending on the assumption, it could be a huge impact on the model outcome. That is why it is import to be transparent about the assumptions and assess its impact to determine if the model is fit for purpose.
How can we gain more information from Phase 1 first-in-human clinical trial?
We understand first-in-human trials are a critical milestone in drug development. We are highly experienced in designing these types of clinical studies to be as flexible as possible, adapting to the rapid incoming data and to avoid delays from protocol amendments. Depending on your therapeutic target, we can suggest a study design that could give you early insight into whether your drug is likely to be efficacious or not.
Regulatory agency suggested we make significant changes in our clinical study protocol? Should we accept their suggestions?
It depends. Sometimes the agencies require further clarification, or a scientific rationale from a different angle. This is something we can advise depending on your circumstances.
Contact

Find out how we can help

     

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    ADME Non-clinical DMPK

    Early career in the laboratory performing bioanalysis, PK analysis and ADME screening assays for drug discovery.

    Clinical Pharmacology

    Experienced in drug development across all clinical study phases including First-in-Human SAD/MAD, Drug-Drug Interaction, Thorough QTc studies and more.

    Pharmacometric Modelling and Simulations

    Hands-on pharmacometrician using various modelling tools to support and de-risk different stages of drug development including in vitro to in vivo extrapolation, exposure-response analysis and more.
    Expert in PBPK modelling complimented by ADME experience.

    Regulatory Interactions

    Global drug applications support for USA, EU, UK, Japan, China, Switzerland, Australia and more.