05.30.24 -- New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies

While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Learn how these issues can be avoided.

Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.

Real-time viable particle monitoring instruments have been available for over a decade. Learn about this technology and how it is used to detect viable particles in real time.

Explore the essential components of cleanroom design necessary for Category 2 drugs to adhere to the updated stipulations within USP 797 / 800 chapters.

Better understand Clinical Trials Regulation No. 536/201 (CTR) labeling changes and their potential to disrupt traditional clinical supply strategies that adhere to the new requirements.

Scaling a new drug formulation from development to manufacturing often presents challenges, but there are ways to minimize deviations and streamline your transition.

Explore the application of in vitro flux assays to nanoparticles, with data on how the in vitro permeability apparatus can characterize the membrane flux performance of an API formulated as a nanosuspension.

Single-use (SU) systems and components are growing in demand as they offer minimal contamination risk. Review a standardized SU assembly for bulk-fill processing that aims to improve efficiency.

Dysphagia impacts treatment compliance and disproportionately affects the elderly. Learn how the microencapsulation-enabled formulation of a water-soluble powder drives patient adherence.

Gain valuable insights into the jet milling process and Quality by Design approach for inhalation drug delivery and their potential applications in drug development.

Review the purpose, technology, and functionality of track and trace in the pharmaceutical manufacturing and production process.

These three studies cover a product that aims to address unmet needs around the development of subcutaneous drug therapies for chronic disease treatment, including methods for sterilization and more.