Bioequivalence study has been conducted for finished medical products (generics).
Our laboratory offers services on comparing the dissolution profiles of generics with the original medicines.
Our advantages:
- verification of pharmacopoeial methods for assay of the active substance released
- development and validation of procedures for assay of the active substance released
- full qualification of the dissolution apparatus in accordance with USP requirements
- calculations and statistical processing of data with using a computer program
- Preparing a full test report
Regulations
Standard document of Ministry Of Healthof Ukraine 42-7.1: 2017 Medicines. Investigation of bioequivalence
Pharmacopoeia of Ukraine, 5.N.2 “Investigation of bioavailability and bioequivalence of generic drugs”