The Role of Q1/Q2 (Q3) Deformulation in ANDAs Q1/Q2 is a term that refers to the assessment of inactive ingredients that is part of all ANDA filings. In the chemistry, manufacturing, and controls (CMC) portion of Sec. 314.94, “Content and format” of an ANDA, it states that “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. Q1/Q2 Sameness Evaluation Q1 Assessments: Demonstrate qualitative sameness Identify an inactive ingredient Provide information about grade and the chemistry of each inactive ingredient Q2 Assessments: Demonstrate quantitative sameness Determine the quantity/concentration of an inactive ingredient FDA has typically found differences of +/-5% acceptable Q3 Similarity Q3 Assessments: Confirm physicochemical similarity to the RLD Parameters may include appearance, pH, globule size distribution, rheological behavior, drug polymorphic form, drug release, etc. https://www./anda-regulatory-pathway-q1-q2-q3-deformulation-equivalence/ |
|
|
