From GI simulators to virtual bioequivalence. We help formulation and biopharmaceutics teams quantify risks that others only discover in vivo.
Oral dosage forms enter an environment with constantly changing pH, motility and content composition, which can radically alter their disintegration, dissolution and systemic exposure. These points of variability are exactly what must be understood to truly “predict the unpredictable.”
Once swallowed, oral dosage forms enter a dynamic GI environment where shifting conditions can alter behaviour and patient exposure beyond predictable patterns.
We combine our proprietary biopredictive tests with PK/PD modelling to de-risk drug development. By mimicking the physiological stresses of GI transit, we provide the mechanistic insight needed to ensure formulation reliability and accurately forecast clinical risks and outcomes.
Validated IVIVC correlations further reduce clinical trial risk.
We design and run biopredictive in vitro studies and PK modelling to anticipate the behaviour of oral drug products under variable gastrointestinal conditions and in clinical settings.
In our small-scale dissolution tests, we rapidly screen formulation concepts under biopredictive conditions media while conserving valuable material. This approach early eliminates risky formulations and focuses development on the most promising candidates.
For biomolecules in complex media we assess molecular stability under realistic gastric and intestinal conditions, including exposure to pepsin, pancreatin, milk, lipid emulsions and simulated chyme. We combine this with specialised analytics to reliably predict which candidates are likely to retain activity after oral administration.
With PK simulations and virtual BE, powered by our Compass™ and LADMEos2™ software, we integrate biopredictive in vitro data into pharmacokinetic models. This enables prediction of concentration–time profiles, BE failure risk and the impact of physiological and formulation variability long before clinical studies begin.
We use our own GI simulators, low-volume systems and PK software to turn complex gastrointestinal physiology into predictable data for your projects.
AMP™ is a modular platform simulating motility, pH, digestion, and transfer to predict complex formulation behaviour along GI transit.
pHysio-grad® and loVol® create low-volume setups to generate realistic pH gradients and quickly screen solubility and dissolution where high-volume tests fail.
Compass™ and LADMEos2™ turn biopredictive data into PK simulations and BE trials, predicting concentration–time profiles and Cmax/AUC differences.
We are a multidisciplinary team of scientists and engineers pioneering the development of biopredictive dissolution testers and PK/PD tools. By integrating laboratory expertise with advanced engineering and analytics, we bring predictability to the most complex challenges in oral drug development.
19.02.2025
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19.02.2025
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19.02.2025
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The NLM serves as a critical bridge between complex research and real-world health applications for, researchers, health professionals, and the, public.
This section presents the current job openings available within the organization.
Conducts experimental and analytical studies to evaluate the absorption, distribution, metabolism, and excretion (ADME) of drug candidates. Designs and executes in vitro and in vivo experiments, interprets pharmacokinetic data, and collaborates with cross-functional teams to optimize drug formulations and support regulatory submissions. Requires strong background in pharmaceutical sciences, pharmacokinetics, and laboratory research.
Conducts experimental and analytical studies to evaluate the absorption, distribution, metabolism, and excretion (ADME) of drug candidates. Designs and executes in vitro and in vivo experiments, interprets pharmacokinetic data, and collaborates with cross-functional teams to optimize drug formulations and support regulatory submissions. Requires strong background in pharmaceutical sciences, pharmacokinetics, and laboratory research.
Conducts experimental and analytical studies to evaluate the absorption, distribution, metabolism, and excretion (ADME) of drug candidates. Designs and executes in vitro and in vivo experiments, interprets pharmacokinetic data, and collaborates with cross-functional teams to optimize drug formulations and support regulatory submissions. Requires strong background in pharmaceutical sciences, pharmacokinetics, and laboratory research.
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