PBBM builds on traditional PBPK modelling by incorporating formulation-specific data—such as solubility, dissolution, and excipient effects—to simulate in vivo drug performance. This approach enables early risk identification and supports formulation decisions that improve bioavailability and reduce development delays.
Upfront knowledge of absorption risks can trigger early assessment of solid form and formulation strategies designed to achieve target bioperformance. Our dedicated PBPK modeling experts work with your compound to:
- Identify absorption risks such as solubility, dissolution rate, and permeability
- Forecast fraction absorbed in preclinical and clinical species over a range of doses
- Predict the likelihood of food-drug or pH-dependent drug-drug interactions
We identify risks like poor solubility, slow dissolution, low permeability, and sensitivity to gastric pH using in vitro data and simulation tools.
We evaluate salts, cocrystals, amorphous solid dispersions, and micronized forms to enhance absorption and reduce variability.
We forecast fraction absorbed across species, doses, and prandial states to guide study design and avoid repeated trials.
We use ADMET Predictor® and GastroPlus® alongside extensive in vitro testing to deliver predictive insights. Our PBPK modeling team works closely with your compound to ensure modeling aligns with your development goals.
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.
- Design and optimize preclinical and clinical studies with respect to dose, prandial state, or gastric pH modification to maximize the likelihood of achieving desired pharmacokinetic profiles
- Forecast oral fraction absorbed in preclinical or clinical species over a range of doses for target drug product formulation(s)
Meet our PBBM expert - Josh Marsh
Bioavailability Enhancement and PBPK Lead Scientist
Bend, Oregon, USA
Watch Josh highlighting a growing trend in the early phase space where poorly soluble molecules are becoming more prevalent, posing a challenge to the current solubility enhancement technologies in the industry. The use of PBPK modeling to understand absorption risks can lead to the development of better formulation strategies, resulting in cost and time savings for our clients.
Our PBPK modeling and PBBM expertise help you reduce risk, accelerate timelines, and improve clinical outcomes. Let’s collaborate to bring your drug to market with confidence.
PBPK stands for Physiologically Based Pharmacokinetic. It refers to a modeling approach that mirrors real physiological systems to predict how chemicals move through the body.
PBBM stands for Physiologically Based Biopharmaceutics Modeling. It’s a specialized extension of PBPK that zeroes in on the biopharmaceutics aspects—how a drug's formulation and dissolution influence absorption and ultimately systemic exposure.
PBPK (Physiologically Based Pharmacokinetic) models focus on the overall ADME processes—absorption, distribution, metabolism, and excretion—using physiological compartments to predict how drugs move and persist across organs and tissues.
PBBM builds upon PBPK by incorporating formulation-specific details—like particle dissolution, excipients, and dosage form—to mechanistically link in vitro formulation data with in vivo bioavailability predictions
The PBPK model scheme is a multi-compartment structure that mimics the body's organs (such as liver, kidney, gut, lung, muscle, fat, brain), connected by blood flow. It uses differential rate equations for each compartment to describe ADME (absorption, distribution, metabolism, excretion) processes in a mechanistic way.
PBPK models are mathematical, mechanistic frameworks that represent organs and tissues as distinct compartments. They integrate anatomical, physiological, biochemical, and drug-specific data to simulate ADME behaviors over time. These models support predictions of species- and population-specific pharmacokinetics and guide drug strategy or toxicity assessments.
The Rule of 5 (Lipinski's Rule) is a guideline to assess oral drug likeness. It suggests a compound is more likely to have good oral bioavailability if it meets at least three of these criteria:
- ≤ 5 hydrogen-bond donors
- ≤ 10 hydrogen-bond acceptors
- Molecular weight ≤ 500 Da
- Log P ≤ 5
Pharmacokinetics (PK) covers how a drug moves through the body—commonly summarized as ADME:
- Absorption: entry into the bloodstream
- Distribution: spread through tissues and fluids
- Metabolism: chemical transformation, typically in the liver
- Excretion: elimination via urine, feces, etc.
