国际药学与生命科学研究与发展杂志

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Quality Improvement with Scientific Approaches (QbD, AQbD and PAT) in Generic Drug Substance Development: Review

Raman VVSSN, Useni Reddy M, Arunkanth Krishnakumar N, Maheshwar Reddy M, Hanimi Reddy B and Narendra Kumar T

Drug substance synthesis requires strong chemistry knowledge and innovative thinking to publish and challenge patents. Creative synthetic route supports to have critical patent claims and challenges the entry of generic players in the market. Since innovators are covering many parameters like stereo selective (isomerism), polymorphic (crystallinity), salt or ester form, impurity profile apart from residual solvents, chemicals and reagents in their patents, drug substance synthesis is a big challenge to the generic manufacturers. Generic drug manufacturers target is to develop a simple and cost effective synthetic route to meet the market competition from other players. Drug substance development can be employed with two approaches traditional and/or scientific approaches. Traditional approach progressed with previous knowledge, reactions reproducibility, less experimental data when compared with scientific approach. In recent years all regulatory agencies are recommending to follow scientific approach rather than traditional approach. Scientific approach can be employed with scientific tools such as quality by design (QbD), analytical quality by design (AQbD) and process analytical technology (PAT) for process development and manufacturing. These three tools will provide enough understanding on drug development and manufacturing. Authors have discussed about quality improvement with scientific approaches.