Reverse engineering (also known as Deformulation), is a key part of generic drug developmen and the abbreviated new drug application (ANDA) process. The role of Q1/Q2 (Q3) or Sameness Evaluation of a Generic Drug Product Formula is briefly discussed below- 


Q1 (qualitatively) Assessments:

  • Demonstrate qualitative sameness
  • Identify an inactive ingredient
  • Provide information about grade and the >chemistry of each inactive ingredient


Q2 (quantitatively) Assessments:

  • Demonstrate quantitative sameness
  • Determine the quantity/concentration of an inactive ingredient


Q3 (similarity) Assessments (RLD characterisation):

  • Confirm physicochemical similarity to the RLD
  • Parameters may include appearance, pH, globule size distribution, rheological behavior, drug polymorphic form, drug release etc.

Q1/Q2 is a term that refers to the assessment of inactive ingredients that is part of all ANDA filings. Where an applicant must identify and characterize the inactive ingredients in the proposed drug product and provide information demonstrating that such inactive ingredients do not affect the safety or efficacy of the proposed drug product.” For some complex ANDAs, Q3 similarity data may also be required.