Accelerating Complex Generic Drug Development Through Advanced Deformulation

Since FDA's 2015 policy change, applicants are told only that a formulation deviates from Q1/Q2 requirements, not which component is responsible. That puts the diagnostic work squarely on the generic developer.

This paper lays out a Q1/Q2/Q3 deformulation workflow built on 21 CFR 314.94 and product-specific guidances, with an excipient-class instrumentation matrix to match each analyte to a detector. Laboratory case studies cover hydroxyethyl and hydroxypropyl cellulose, magnesium stearate, and sodium starch glycolate. None has a UV chromophore, and each presents its own separation problem, from gelling polymers to a magnesium stearate extraction that demands mass balance.

Review the methods and data behind the stepwise approach.