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Essential Similarities

Quantitative (Essential) Similarity

Generic medicines provide an affordable alternative to branded (innovator) drugs once they come off patent. The path to generic registration is made simpler in Australia due to the absence of a requirement to conduct an in vivo bio-equivalence study, provided a suitable study has been conducted elsewhere in a harmonized region.

A comprehensive quantitative comparison of replicate innovator batches from Australia with replicates from the harmonized region is conducted and submitted to the TGA for assessment.

Quantitative comparative data include assays for all functional excipients, in vitro dissolution rate comparisons at several pH values, certificate of analysis testing on the finished product API (e.g. assay and related substances testing, uniformity of dosage).

Quantitative comparative data may also include assays for some or all coating excipients, water content, individual dosage form masses and dimensions. Qualitative comparative data using unvalidated methods include FTIR and XRD spectra, appearance, digital imaging and package scanning.

Modified release dosage forms are treated separately by the TGA, and submitted information now requires a comprehensive assessment of the quantitative similarity of the protective coating or slow release bulk excipient. Chemical Analysis has a range of techniques which address this complex factor.

Chemical Analysis has an impeccable record on product registration testing and is able to assist in all stages of product registration:

  • Reverse engineering of competitor generic or innovator
  • Pre-screen of different strengths for similarity
  • Method development
  • Excipient method validation and assay
  • Finished product CofA, including microbiology
  • Physical and spectroscopic testing
  • Dissolution testing
  • Modified release capability
  • Comprehensive comparison summary and all validation reports
  • Comprehensive testing of dosage form
  • Stability storage at all ICH conditions
  • Stability indicating method development and validation
  • API/raw material BP/USP monograph testing for local manufacture
  • GMP certified, FDA inspected
  • TGA/APVMA licensed
  • ICH and PICS compliant
  • Permits for all Schedules including S8 and S9
  • Experience with cytotoxics