Drug Development Solutions

AI-powered biopharmaceutical classification prediction to optimize your drug development pathway and minimize biowaiver rejection risk.

Why risk biowaiver rejection for non-eligible BCS class drugs?

Our AI-driven BCS (Biopharmaceutics Classification System) prediction helps you make informed early-stage decisions about biowaiver vs bioequivalence studies

Reduce Development Risk

Minimize biowaiver rejection risk for non-eligible BCS classes with accurate BCS class predictions, enabling confident pathway selection in early development stages.

Accelerate Timelines

Make faster go/no-go decisions with instant BCS predictions, reducing time to market for promising drug candidates.

Optimize Resources

Allocate R&D resources more efficiently by identifying the most appropriate regulatory pathway early in development.

Biopharmaceutics Classification System (BCS)

Understanding drug solubility and permeability for optimal development strategy

Class I

High Solubility, high permeability

Biowaiver eligible ✅

Class II

Low Solubility, high permeability

Requires bioequivalence 💰

Class III

High Solubility, low permeability

Biowaiver eligible ✅

Class IV

Low Solubility, low permeability

Requires bioequivalence 💰

Biowaiver vs Bioequivalence Decision Support

Our AI models provide BCS class prediction to guide your regulatory strategy

Biowaiver Pathway

When to consider:

  • BCS Class I, III prediction using our models
  • Immediate release solid dosage forms
  • Rapid dissolution profile

Benefits:

  • Minimum risk of biowaiver rejection for likely non-eligible BCS class drugs
  • Saves clinical study costs
  • Faster market entry
Bioequivalence Pathway

When to consider:

  • BCS Class II, IV prediction using our models
  • Modified release formulations

Benefits:

  • Save the costs of lab-based BCS classification for likely non-eligible drugs
  • Save precious time of R&D for likely non-eligible drugs

Ready to Optimize Your Drug Development Strategy?

Get accurate BCS predictions and decision support to minimize development risk and accelerate time to market.