Praedicare Laboratories provides a range of services to support drug development and clinical trials.
- Assay development & study design
- Hollow fiber testing to determine PD, PK, toxicity, efficacy & optimized dose regimen (including multi-drug regimens)
- Artificial 3-D human organoids for more specialized testing
- Longitudinal sampling during hollow fiber studies allows for multiple downstream analyses (RNA seq, standard clinical testing, etc.)
- Advanced analytic tools and mathematical modeling
- Consulting support for IND development & filing
Value of hollow fiber in drug development
- Provides early clinically relevant go/no-go decision point for drug candidates prior to animal model testing and human clinical trials
- Reduces animal usage by identifying optimal dosing strategy in advance of taking the drug candidate into animals
- Strengthens submission for IND by providing more clinically relevant data than even vertebrate animal testing in some cases
- Reduces time to IND filing by streamlining the iterative dose-optimization stage
- Provides significant financial savings by reducing animal usage, shortening time to decision points (allowing earlier identification of no-go candidates), shortening time to IND filing and by adding precision in predicting efficacy of drug candidates
- Comparison studies with standard-of-care regimens can be used as evidence for supporting reimbursement decisions once a drug is on the market.
What is the hollow fiber system?
The hollow fiber system (HFS) is an enclosed two-chamber system that consists of a peripheral “pharmacodynamic” compartment and a central “pharmacokinetic” compartment. Drug equilibrates with cells in the peripheral compartment via diffusion across the semi-permeable hollow fibers. The HFS mimics the pharmacokinetic concentration-time profiles of drugs in the clinical setting. We can perform PK/PD studies that will inform dose selection in clinical trials.
Visit our Technology & Services page for more detailed information about the hollow fiber system and all of the services that we offer.
In-House assay Development & Screening. As one of the first steps in drug development, timing is critical. PraeDicare Labs works to take on this critical step and provide accurate toxicity testing and creating test systems on which to evaluate the effects of chemical compounds on cellular, molecular or biochemical processes of interest.
Advanced mathematical modeling, computer-aided clinical trial simulations, and artificial intelligence algorithms, enhances the results of animal testing and the translation of results into a humanized-model for better prediction of drug performance in the clinical trial phases