How can the application of advanced analysis tools help with accelerating generic drug product development?
In response to pressure of healthcare providers to increase access to medicines while managing costs, global regulators have been considering the requirements for encouraging increased generic competition. Within this, specific interest has been given to the challenge of developing complex drug products where, due to the nature of the formulation or route of delivery, the development of generics is more difficult. In response to this challenge, regulators, such as the US FDA, have released product-specific guidance aimed at advising generic manufacturers as to the approaches which may be applied to prove bioequivalence in vitro through the measurement of a drug product’s physicochemical properties.
In this webinar series, we will consider the guidance which has been issued for different complex drug products, highlighting the support which Malvern Panalytical and our partners can provide in understanding formulation physicochemical properties using novel analytical methods. Each webinar will consider a different class of complex drug products such as nano-drug delivery formulations, ophthalmic products, topical creams and oral solid dose products. We’ll end the series in December by considering Orally Inhaled and Nasal Drug Products (OINDPs) and how the assessment of Q3, or microstructural, equivalence in vitro has enabled the successful development of recent generic products.
So, what are the novel analytical methods are relevant to in vitro bioequivalence studies? In this first webinar in the series, we will introduce the general topic of in vitro bioequivalence testing. We’ll consider the typical physicochemical properties highlighted in recent guidance from the US FDA, and other regulatory authorities, as being important in assessing Q3 equivalence and will introduce the tool box of physicochemical analysis methods available from Malvern Panalytical to support in vitro studies. As part of this we’ll consider how this tool box has been applied for product deformulation or bioequivalence assessment in the case of a simple topical formulation and an oral solid dose product.