Stability testing is, in essence, a quality control process and is therefore a vital component of every phase of clinical development for both large and small molecules – from early phase through to and including post approval. It should be treated as an ongoing program rather than as a periodic exercise.
Programs that need to include women in their FIH studies will find that successful enrollment of women is achievable; however, it requires a concerted effort, with the correct strategies and proper support. In the following pages, we explore the challenges in recruiting women for FIH studies and present a set of practices that have proven successful towards improving the recruitment rates of women for these studies.
Industry Best Practices for their Detection and Characterization
Monoclonal antibodies and next generation molecules such as antibody-drug conjugates (ADC) are being developed and moved into early phase clinical testing. These new molecules bring challenges for measuring immunogenicity within human serum samples.
The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing as a surrogate for in vivo testing.