Measurement of drug release from complex dosage forms intended for ophthalmic and topical applications is fundamental to drug product development and product equivalence testing. Inherent to the concepts of quality target product profile (QTPP) and quality by design (QbD), IVRT allows for targeted and systematic drug development and guides the establishment of therapeutic equivalence. The combination of Absorption Systems’ years of experience in developing and validating in vitro approaches and regulatory interactions results in quick, efficient and accurate IVRT testing that can be used to establish product equivalence and/or for continuous batch release testing.
Study Design
Bioequivalence:
- Optimization of study conditions: Analytical, receiver buffer, membrane selection, and time-point selection
- Establishment of sensitivity specificity and selectivity
- Qualification of the optimized assay parameters
- Validation: Analytical method validation and test system validation
- Pivotal bioequivalence comparison with statistical evaluation
Batch Release:
- Optimization of study conditions: Analytical, receiver buffer, membrane selection, and time-point selection
- Establishment of specificity, selectivity, and sensitivity
- Qualification of the optimized assay parameters
- Validation: Analytical method validation and test system validation
- Establishment of QC test method and recommended release specifications
