Ashish A Mungantiwar,
Macleods Pharmaceuticals Ltd., India
Title: Assessment of Bioequivalence of respiratory dosage forms
Biography
Biography: Ashish A Mungantiwar,
Abstract
Statement of the Problem: Respiratory dosage forms are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. The global sales data estimates for asthma is approximately $15.9 billion. The US itself contributes 64% of the sales mainly due to much higher prices and lack of generic inhalers in the market. Introduction of generics is essential as pricing is barrier to patient care. However, regulatory approvals of these products by different agencies are demanding and are not harmonized.
Methodology & Theoretical Orientation: Current topic will cover US and EU requirement of bioequivalence and in-vitro performance studies. Understanding various study designs and challenges. Presentation will also cover current practice and precautions to be taken during the conduct of bioequivalence studies.
Conclusion & Significance: This presentation will critically review requirement and present future directions for clinicians, scientists, and regulators to consider optimizing the development and approval of drug products for respiratory dosage forms.