PBPK Modeling Services

Does my drug have absorption risks?

What solid forms/formulations can mitigate absorption risks for my drug?

How should I design my pre-clinical or clinical studies to achieve desired outcomes?

Early identification of potential absorption risks, such as poor solubility, dissolution, and/or permeability is critical for rapid and efficient drug development. Upfront knowledge of absorption risks can trigger early assessment of solid form and formulation strategies designed to achieve target bioperformance.

Once an absorption risk is discovered, solid forms and formulation strategies can be identified early to mitigate these risks, avoiding unexpexted reformulation. For example, salts, cocrystals, micronization, or amorphous solid dispersions are potential strategies for enhancing solubility and dissolution rate.

Designing preclinical and clinical studies with respect to species, dose, prandial state, and gastric pH modification is important for maximizing the likelihood of achieving desired pharmacokinetic profiles and avoiding repeated studies.

Meet Deanna Mudie, Ph.D.

Principal Scientist in Research and Development

Bend, Oregon, USA

Deanna Mudie is a Principal Scientist in Research and Development at Lonza's site in Bend, Oregon, USA. Since she joined Lonza in 2016, her focus has been on enabling bioavailability-enhancing amorphous solid dispersions by developing dosage form platforms and in vitro dissolution methodologies to predict bioperformance. Deanna earned her B.S.E. degree in Chemical Engineering and her Ph.D. in Pharmaceutical Sciences from the University of Michigan. She has seven years of predoctoral experience at Pfizer and Merck developing and manufacturing oral dosage forms from preclinical to commercial scale.

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