A more comprehensive and deeper understanding of the critical properties and characteristics of the Reference Listed Drugs (RLDs) is necessary to develop successful (consistent quality and efficacy) generic drug formulations.
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The purpose of pre-prescription studies is to provide a basis for generic drug formulation process design, and to provide reliable solutions to problems that arise during the formulation process studies. In addition, another important aim of pre-prescription research is to provide a proof for preliminary risk assessment for formulation studies and to determine the direction of formulation studies. As an important part of the consistency evaluation, the results of pre-prescription studies also offer indispensable evidence for passing the review of CDER. Alfa Chemistry offers reliable pre-prescription studies, providing studies on the physicochemical properties of active ingredients and excipients, reverse engineering of the RLDs, quality control methods, product life cycle management, etc.