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Analytical development and Stability studies

Analytical development
Analytic method development is a key element of any pharmaceutical drug development program. Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. Method development is a continuous process that progresses in parallel with the drug development. The goal and purpose of the method should reflect the phase of drug development. During early drug development, the methods should be suitable to support pre-clinical safety evaluations, pre-formulation studies, and product stability studies. Up to and including clinical trial Phase 1, analytical methods need only be qualified, not validated. Linearity, precision, accuracy, and specificity will suffice at this stage. As drug development progresses, the analytical methods are refined and expanded, based on increased drug product knowledge and method validation must be completed as the drug progresses through Clinical trial Phase 2 and Phase 3, and commercialization.

Stability studies
Stability studies are an essential component of pharmaceutical drug development program. They should include testing of those attributes that are susceptible to change during storage and are likely to influence quality, safety and/or efficacy of the pharmaceutical drug. The testing should cover, as appropriate, the physical, chemical, biological and microbiological attributes. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.

Progress-PME can support you during analytical development. The Progress-PME experts can provide scientific advise varying from early stage analytical development through complete validation of the methods in order to have an analysis which is “fit-for-purpose”. In addition, Progress-PME can support you to set up a scientific sound stability program. This includes writing of stability protocols and reports, combination of analyses by bracketing and matrixing to be as efficient as possible through data interpretation of the results. 

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