These studies begin with pre clinical phase to support animal toxicology.
In Phase I, studies are used to establish drug/ excipient compatibility to assist in formulation development and ensure the stability of the API as formulated in the Clinical Trial Material (CTM).
These studies are conducted on the drug substance, and drug product and comparators during clinical trials.
These programs form the basis for understanding degradation kinetics and therefore provide scientific rational for the final specifications and shelf-life.
Most importantly, these studies are performed on manufacturing scale-up and/or process validation batches, and registration batches in final formulation and packaging for New Drug Application ( NDA / MAA ) fillings.
Phase IV, marketed product stability studies are conducted to ensure commercial Quality Control.
Scale-Up and Post Approval Changes (SUPAC) and Product Life Cycle Management (PLCM) stability studies are used to support changes in the existing process and new dosage forms, delivery systems, and changes in packaging.
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