Pharmacokinetics fed by TIM® data
TIM PK
TIM PK is an in vitro-in silico approach that translates physiological TIM® drug release, dissolution and permeation data into predicted in vivo absorption and pharmacokinetics (PK). TIM PK is typically used to predict absorption and PK performance, guide (drug) formulation optimization and develop in vitro–in vivo correlations (IVIVC).
Why pharmacokinetics matter
Pharmacokinetics focuses on how medications are absorbed and move through the body. Understanding how drugs are absorbed, distributed and metabolized helps scientists understand if and for how long a substance remains in the blood at a therapeutic level.
Selecting the right active pharmaceutical ingredient (API) and designing effective oral formulations is becoming increasingly challenging. Many APIs show poor solubility or absorption, and conventional dissolution methods fall short in predicting human gastrointestinal performance, creating costly inefficiencies and uncertainty in bringing new therapies to market.
Applications
Guide formulation optimization, clinical strategy and regulatory confidence
TIM PK can be used to predict absorption, distribution, metabolism, and excretion (ADME) processes, for challenging APIs and complex oral formulations. It enables evaluation of food effects, virtual bio-equivalence, first-in-human dose prediction, and in vitro-in vivo correlation (IVIVC) with high accuracy.
TIM PK translates formulation behavior as determined in TIM Upper GI experiments (including e.g. food effects (PPI), atypical gastric emptying etc.) to expected exposure of the drug in patients or populations. It also supports in building regulatory credibility by investigating bio-waiver potential and creates confidence by evaluating drug performance at extreme conditions, helping developers build stronger submissions and make informed, evidence-bases decisions.
TIM PK helps you to get unmatched insights and actionable predictions, accelerating smarter, safer, and more effective drug development.
TIM PK translates formulation behavior assessed using TIM Upper GI to expected performance in a patient or population
Unique features
- Directly fed by TIM Upper GI, TIM Colon and/or TIM Cell in vitro data for the most trusted outcome
- Using industry-leading PBPK/PBBM software, trusted by regulators and applied across diverse real development and regulatory use cases
- Able to predict drug performance in the average subject and at extreme conditions of a population
- Identification of critical bioavailability limiting attributes
Get in contact
We are excited to hear what’s on your plate and how we can help you understand what happens to your product during digestion!
