Gain insight into some of the most critical considerations for successful pharmaceutical stability studies. Access our On Demand Webinar Series.
Pharmaceutical stability studies are complex and present many challenges. They play an essential role across the lifecycle of pharmaceutical products and in particular, during the development of Investigational New Drug (IND) and New Drug Application (NDA) submissions. As stability programs can demand considerable time and scientific expertise, whether you intend to implement in-house or by working with an outsourcing partner, it is important to carefully consider all aspects of your studies.
Access our On Demand webinar recordings which cover some of the important considerations for efficient stability programs, including the practicalities of working with a contract laboratory, optimising stability protocol design, stability testing and how to tackle specific product categories such as biopharmaceuticals or inhalation products.
Presenter: Kerry Bradford, Laboratory Manager
Based on years of experience our expert, Kerry Bradford, shares her thoughts on what steps you can take to ensure that your outsourced stability studies run like clockwork. What information should be included in a stability protocol?
What in-house knowledge does everyone assume that a contract laboratory may not know? What will happen to your samples when they go to a contract laboratory for storage?
These, and many other questions you didn’t even know you had, will be answered by our expert who has had the opportunity to gain experience of stability protocols from many different clients and take best practice from each to ensure your protocol covers all the points a contract laboratory will need to know to make your study run like clockwork.
Presenter: Mark Parry, Technical Director, Intertek Melbourn
Stability studies play an important role in inhalation medicine development, arguably more so than other delivery systems. In addition to allowing evaluation of the chemical stability of the active drug(s), stability studies enable recommended storage conditions, retest intervals and shelf lives to be established. These studies allow assessment of the effect of temperature and humidity, which can adversely affect both the size distribution of the delivered medicine by reducing the dosage at the target area of delivery and the effectiveness of drug delivery from the device. This webinar will cover study design and testing to address the specific challenges that are associated with this product category.
Presenter: Ashleigh Wake, Director Biological Services
Biopharmaceutical stability studies are essential to assess sensitivity to factors that could cause aggregation and degradation which impacts biologic activity, product safety, and quality. But, what is important in the design and conduct of stability studies for biologic medicines? What are the potential “pit falls” and what steps can you take to ensure success? The challenges and real life case studies in biopharmaceutical stability studies will be discussed during this short webinar with Intertek’s Director of Biological Services.
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