Roohi Kesharwani, Md Shariq Ansari, D K Patel


Preformulation is a study which deals which provides the framework for drug’s combination with pharmaceutical ingredients in the fabrication of dosage form. Preformulation study is to develop the elegant dosage form by the establishing kinetic rate profile, compatibility with the other ingredients, establish physicochemical parameter and polymorphism of the new drug. Among these properties the preformulation also provide the information regarding degradation process, adverse condition relevant to the drug, bioavailability, pharmacokinetics, toxicity, drug stability, partition coefficient, dissolution rate, and polymorphic forms. Preformulation studies strengthen the scientific foundation of the guidance, provide regulatory relief and conserve resources in the drug development and evaluation process, improve public safety standards, enhance product quality, facilitate the implementation of new technologies. According to ICH, all technical requirements for the application of drug approval were homonized in CTD format which are scientifically more elaborate by USFDA in QoS-QbR format. QbR is based on the principle of Quality by Design (QbD) which increased efficiently in the FDA review process.


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