ON-DEMAND WEBINAR: Demonstrate Abuse-Deterrent Properties in Opioid Formulations

Prescription opioid abuse has reached epidemic levels in the United States, with nearly 20,000 deaths in 2014 (the most recent year for which statistics are available) from unintentional overdose of prescription opioids and nearly 36,000 deaths in which prescription opioids were either directly or indirectly implicated. This issue has become a major regulatory focus over the last several years and has resulted in the issuance of FDA guidances requiring abuse-deterrent properties for new opioid drug formulation NDA’s (final guidance April 2015) and generic ANDA’s (draft guidance May 2016). A major component of proving the abuse-deterrent properties for a new formulation is the execution of in vitro manipulation and extraction studies, which companies are increasingly turning to CRO’s to perform.

Topics: Webinars

WEBINAR: Critical Drug Substance Considerations for Formulation Success in Drug Product Development


Join Alcami for a webinar on Tuesday, December 20, discussing critical drug substance considerations for formulation success in drug product development.

Understanding the solid state properties of a drug candidate molecule is of critical importance for successful dosage form development. It takes close collaboration and communication between solid state characterization scientists, synthetic process chemists, analysts and engineers, and formulation development personnel to reduce risk, both in time and cost.

Alcami’s ProForm Select™ is a unique offering designed to provide pharma-biotech companies a control strategy that is integrated and end-to-end, reducing process instability which can delay clinical milestones or commercial supply. From development to clinical and commercial, this service offers the unique integration of API process chemistry and Drug Product formulation development in parallel, driving right-first-time results.

This webinar will present the ProForm Select™ offering, featuring solutions to your biggest development challenges:

  • Selection, optimization of API process, Drug Product formulation, and control of end-to-end manufacturing process
  • Integrated and simplified supply chain for development and manufacturing
  • Reduced timelines and cost through parallel development and cyclical process feedback
Topics: Webinars

WEBINAR: How to Submit a Sample Using Alcami’s Enhanced Online Sample Submission Process


Join Alcami for a webinar on Monday, November 7, discussing how to submit a sample using our enhanced online sample submission process.

As an industry leading and innovative organization, Alcami continues to evaluate and improve our processes to create the best client experience. In doing so, Alcami has enhanced the user experience and the ease of submitting samples for analysis.  

Topics: Webinars