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Demonstrating Bioequivalence

The global generic drugs market has experienced rapid growth in recent years, driving the need to address the specific scientific challenges facing the development of generic drug products. The demand for safe, cost-effective, and effectual treatments of respiratory diseases is also growing due to the rising global prevalence of conditions such as chronic obstructive pulmonary disease and asthma.

The development of generics requires the demonstration of bioequivalence (BE) with a reference product. BE studies typically follow on from the characterisation of a reference product and the design of a pharmaceutically equivalent and bioequivalent product. Demonstrating BE in locally-acting drugs, such as orally inhaled products (OIPs), is particularly challenging, primarily because OIP behaviour is a function of the interactions between the patient, device, and formulation. Advances in bioequivalence methodology provide an opportunity to accelerate the development and marketing of generic drugs while also maintaining safety, quality, and efficacy standards.

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Mark Copley graduated from the University of Bath, UK, in 2000 with a master’s degree in aerospace engineering. For eight years, he was Technical Sales Manager and Product Specialist for Copley Scientific’s range of inhaler testing equipment and is now the director of the company. Mark is considered a leading authority in testing methods and systems for metered-dose inhalers, dry powder inhalers, nebulisers, and nasal sprays – authoring and contributing to more than 40 published articles. He also provides application support and consultancy, runs focused training workshops for the inhaled drug testing sector of the pharma industry, and sits on the editorial advisory panel of Inhalation Magazine. An invited member of the European Pharmaceutical Aerosol Group impactor sub-team, Mark has also made recommendations to the Inhalanda working group, leading to subsequent revisions to Ph Eur and USP monographs.

Anna Sipitanou received a BSc in chemistry from the University of Bradford, UK, in 2014, and an MSc in drug discovery and pharmaceutical sciences from the University of Nottingham, UK, in 2015. She also undertook the role of Research Associate at Nottingham, working to build in silico models for the prediction of drug-induced liver injury. Building on her previous experience at Cellomatics Biosciences, Anna joined Copley Scientific in July 2017 as Business Development Manager, playing a key role in the company’s service to customers, including training of a wide range of instruments.
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Mark Copley
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Anna Sipitanou
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