Reverse engineering analysis of a product, also known as “De-formulation studies” is the process of analytically breaking down a material or product’s formulation to separate and determine the specific identity and exact quantity of both its major and minor constituent components of the product. Information gathered from a complete pharmaceutical reverse engineering decodes formulation composition that is necessary in order to reproduce or reformulate the exact product. During such an analysis even the steps involved within a product production process can be re-formulating by carefully expanding upon the information gained in the chemical reverse engineering process. In addition to discovering how to re-develop a product this type of laboratory testing generates a wealth of key information which can help save significant time and money when developing a new, but similar product formulation.
Application for generic approval or potential therapeutic molecule under regulatory bodies requires the demonstration of a bioequivalent product or proof of concept for approval. This means that the blood levels of the active ingredient need to show that the product is highly similar in innovator composition in case of generic and therapeutic activity better than existing therapy line. Innovator’s formula as it is proprietary, contents are not revealed by the agency.
Stabicon team has handled of reverse engineering services for Q1 (Qualitative) and Q2 (Quantitative) equivalency of topical\oral products for IVRT\ Equivalence efficacy studies (Q3) based on Regulatory Guidance & BCS classification system. Expertise is summarized in the table below:
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