Mark Copley Focuses on Bioequivalence Testing for Generics at 6th IPA Symposium

Mark Copley, Sales Director for Copley Scientific, will deliver a presentation at the Indian Pharmaceutical Association’s (IPA) 6th symposium on nasal and pulmonary drug delivery (24–25 October 2013, Mumbai) to discuss bioequivalence testing for inhaled generics. This year, the event will focus on global regulatory trends in inhaled product testing and development. To find out more or to register please visit www.ipapharma.org

The Indian pharmaceutical industry is a global leader in the development of generic inhaled products, primarily for the treatment of chronic obstructive pulmonary diseases (COPD) and asthma. Demonstrating bioequivalence through in vitro testing minimises the need for clinical trials, accelerating time to market and reducing development costs. In a presentation, entitled “Methodologies for in vitro bioequivalence testing of generic inhaled products in emerging markets”, Mr Copley will review the regulatory framework in this area and outline efficient testing strategies that can be used to fulfil the associated requirements.

Copley Scientific is s world-leading manufacturer and supplier of inhaler test equipment with a track record of innovating new products to meet evolving requirements for both novel and generic inhaled product testing. Solutions of particular value for generic testing include a range of equipment for delivered dose uniformity and aerodynamic particle size measurement, cost-efficient breathing simulators for nebuliser testing, and unique instruments such as the Plume Temperature Tester Model PTT 1000 for measurement of the Cold Freon effect. In combination with Copley Scientific’s expert support these products help generics manufacturers to fully meet regulatory requirements and bring new products to market quickly and efficiently.