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The importance of dose prediction for early drug development

Gaining a thorough understanding of the chemical and pharmacological attributes of a drug substance through pre-clinical studies is paramount for providing an effective dosage form for first-in-human clinical trials. Yet often insufficient consideration is given to ‘knowing the compound’ before selecting a presentation for clinical evaluation. In particular, an accurate prediction of an appropriate dose range is vitally important for adopting the most appropriate formulation strategy for the compound. If the formulation is not suitable to deliver the required quantity of the drug then the outcome of the clinical trial may be compromised.

Juniper Pharma Services and XenoGesis work together successfully to provide an integrated biopharmaceutics service offering. The unique combined approach helps to remove the gap between ‘chemical’ and ‘biological’ to provide the most effective drug delivery solutions.

Graham Trevitt joins Rob Harris to provide an insight into how our joint, consultative approach to drug development can help in understanding the absorption and clearance characteristics of a drug substance and how these properties will influence dose prediction and selection of an appropriate formulation strategy.

The free webinar took place on Thursday 6 July 2017 at 3pm BST (UK).

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An Integrated Bio-Pharmaceutics Approach for Effective Drug Development

New drug candidates fail during development for many reasons, centred around:

  • Undesirable absorption and/or metabolism of the compound in man
  • Undesirable pharmacodynamics
  • Poor solubility over the physiological pH range
  • Poor stability of the compound in the gastrointestinal environment

With the constant demands on pharmaceutical scientists to reduce time and cost for development of new drugs, selecting the ‘winners’ and identifying the ‘losers’ in a selection of compounds can increase the chances of success in clinic and help achieve the drug development goals.

Juniper Pharma Services and XenoGesis work together successfully to provide an integrated bio-pharmaceutics service offering. The unique combined approach helps to remove the gap between ‘chemical’ and ‘biological’ to provide the most effective drug delivery solutions.

This approach can help pharmaceutical and biotechnology companies:

  • Predict how a drug will behave in vivo
  • Pave the way to human-optimised medicines
    ◦ Maximize exposure for toxicological studies
    ◦ Maximize or modify drug delivery for clinical trials
  • Optimise drug performance by tailored formulation strategy

The webinar will demonstrate and explain how our joint, consultative approach to drug development, along with our unique Enabling Technologies Rapid Screen can help you to take your compound through to clinic in a seamless, rapid and cost-effective way.

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