The patent clock is ticking…
You’re a pharmaceutical company whose patent on a blockbuster drug is set to expire soon. Or, you’re a generic drug company who wants to have a product ready once that patent expires. You’re both watching the clock and running all sorts of in vitro tests and clinical trials to prepare for the 505(b)(2) or 505(j) application filings, but have you considered all avenues to make your case as strong as possible? A small investment in the mechanistic PK/PBPK modeling solutions from Simulations Plus should pay huge dividends – let’s talk about how we might help.
What can we offer?
- Extrapolate adult PK/efficacy data to pediatric populations with PBPK modeling to achieve rapid approval of new pediatric indications
- Design modified release dosage forms to offer alternatives to B.I.D. or T.I.D. dosing regimens to extend lifecycle management
- Virtually simulate bioequivalence trials to compare predicted PK profiles from reference and test products, or justify the use of new dosage strengths
- Apply virtual ‘lot-to-lot’ variability effects to help establish dissolution specifications – remove the guesswork associated with the identification of dissolution variability and its impact on PK exposure
- Provide statistical assistance on completed trials
- Assess formulation strategies to achieve target dissolution profiles
- Assist with dissolution method development activities
- Integrate GastroPlus absorption/PBPK models with DDDPlus™ in vitro dissolution modeling to optimize formulations and generate mechanistic in vitro-in vivo correlations (IVIVCs)
We recognize the tight deadlines you’re under, so any tasks can be handled by our modeling & simulation experts to provide you with the solutions and insight you need. Learn more about the various services we offer, and be sure to check out our Resource Center to see how your peers are racing against the clock using our technology.