Methods development and Analytical validation

Methods development
  • Assay method development or variation (HPLC, spectrophotometer, TLC, burette)ANALYSTES
  • Assay method transfer
  • Dissolution method development or variation (USP2- USP4)
  • Dissolution method transfer
  • Development of HPLC method for dissolution
  • Development of spectrometric method for dissolution
  • Water content method development.

 

Analytical validation
  • Assay method validation according to ICH Q2R
  • Validation of HPLC and spectrometric method for dissolution
  • Data analysis using a 21CFR part 11 software (e-Noval)
  • Analysis of customer data

In vivo assessments

  • Ex vivo: transdermal and transmucosal permeation using biopsies
  • In vivo: administration to rats, rabbits or mini-pigs of injectable depot (microspheres, implants and microcrystals), buccal bioadhesive tablets, nasal solutions and transdermal gels and creams.
  • Development of LC-MS assays

Examples:

implants              Insuline level in rabbit.pngBIOPOLE-2010-011