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Bioequivalency (in vitro)

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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”

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