Webinar: Testing of the packaging: Extractable study design and challenges
Large volume parenteral applications are characterized by high volume doses of a drug product, which are administered intravenously. Flexible bag systems, which contain a combination of different materials, are often used as container/closure systems. Definitions and regulatory requirements for extractables and leachables testing of large volume parenteral products, will be highlighted. Next, typical sources of extractables and leachables in flexible bag systems for parenteral use will be listed. Emphasis will be put on the specific challenges associated with large volume parenteral applications. Finally, some case studies regarding different designs of extractable studies will be discussed.
Molecular Properties of PROTACs and the Relationship to Formulation Design
December 20th 2024Analyzation of a diverse set of PROTAC (Proteolysis Targeting Chimeras – a class of TPDs) structures and their calculated properties, identifying key structure-property trends that contribute to low oral bioavailability.
Clinical Supply Planning in Europe - Balancing Cost, Flexibility and Time
December 19th 2024The packaging and distribution of clinical supplies is a fundamental piece to the overall success of a clinical trial, and advance preparation can help establish a more efficient supply chain. Selecting the best geographical location for those activities, however, depends on the clinical trial protocol, business decisions, and even the investigational medicinal product (IMP) being studied.
A Discussion: In Vitro Release Testing and Its Application and Use in Generic Topical
December 18th 2024Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy discusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.
