Analytical methodology is critical to the drug development process from drug discovery to post-approval. The data generated are instrumental in gaining an understanding of the physical and chemical properties that can impact product performance.

Verta Life Sciences consultants have experience developing analytical methodology and regulatory strategies for analytical deliverables during all phases of product development.

We will work clients to establish the suite of tests needed to ensure the safety, quality, and global regulatory acceptability of their product throughout it’s lifecycle, such as:

  • Strategies for analytical deliverables
  • Product understanding
  • Parameters and protocols needed for phase appropriate development, validation, and transfer of fit for purpose analytical methodologies
  • Release and stability
  • In-vitro Bioequivalence and bioequivalence waiver approaches
Analytical Development– case study
Issue:

A fixed dose combination product of two generic drugs was under development. An in-vitro test was needed to predict the likelihood of in-vivo bioequivalence to the innovator products and to support a waiver for bioequivalence testing for alternate dose strengths.

Objective:

Develop an appropriately discriminating dissolution method that could be used to:

  • determine which immediate-release formulation(s) should be selected for in-vivo studies
  • support the in-vivo bioequivalence study
  • support a bioequivalence waiver for alternate dose strengths, in accordance with FDA and EMA guidance for the demonstration of bioequivalence
Deliverable:
  • Formulation was selected based on in-vitro dissolution profile comparison which was subsequently shown to be bioequivalent to the innovator products
  • In-vitro dissolution was successfully used to support a bioequivalence waiver for alternate dose strengths