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ABBREVIATIONS

CQA- Critical quality attributes ICH - International conference on harmonization DOE- Design of experiments QRM- Quality risk management FMEA- Failure mode effect analysis ODT- Orally disintegrating tablets USFDA- United States federal drug administration USP - United States pharmacopoeia TPP- Target product profile RSD- Relative standard deviation DT- Disintegration time NDA - New drug application API - Active pharmaceutical ingredient cGMP -Current good manufacturing practices PQLI-Physical quality of life index RTR- Real time release.

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