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13 September 2013

Full Stability studies

One fundamental feature in a drug is to keep unaltered parameters as far as regards quality and effectiveness until the expiry date.

Stability studies, carried out according to legislation and guidelines accepted by the scientific community (in particular those coming from ICH, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), assess the way the features of a pharmaceutical active ingredient change in the course of time depending on different temperature and humidity conditions.

 

Our consulting services

  • Development and validation of stability-indicating methods in compliance with ICH guidelines
  • Drafting and assessment of stability protocols for all kinds of products and for every geographical zone
  • Storage an analysis of active ingredients and finished products as provided for in ICH guidelines
  • Updating of the protocols regarding stability, both on-going and in support of marketing for clinical studies
  • In- progress establishment of specifics limits
  • Assistance in preparing the study protocol
  • Drafting of intermediate reports while performing the study
  • Identification and characterization of unknown breakdown products
  • Performing of analytical determinations while performing the study
  • Drafting of the final report at the end of the study including assessment of achieved results according to the statistical procedures indicated in the ICHQ1E guidelines (Evaluation of Stability Data)
  • In-use drafting of protocols and analysis of stability studies data
  • Studies on induced breakdown (stress testing)
  • Studies on photostability (ICHQ1B)

The assessment of the stability of a product or an active ingredient represents an essential requisite of the whole life cycle of a drug, starting from the initial formulation studies to its marketing.

 

Use cases

  • Before production start-up
  • Before trading
  • Drafting the package leaflet
  • In order to guarantee safety for the consumer using the most adequate methods of preservation of the prescribed drugs

 

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