Captisol is in over a dozen FDA approved products with multiple product approvals coming in the next year. These approvals include oral and ophthalmic routes of administration. Proven safe!
A team of experts with 20+ years of experience who are ready to answer any questions are what sets Captisol apart from other modified cyclodextrins.
Ligand formulation services are now available to assist with consideration of CAPTISOL for solving product development issues and achieving Target Product Profile goals
Panelists on PharmTech AI Pulse Check debate SURPASS, a new digital-twin trial program, regulatory acceptance, and the data-cleanup burden it will create.
Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
Ishani Maharaj of Ingredients + Specialties from Univar Solutions explains how to stabilize GLP-1 multi-agonists, weigh delivery formats, and qualify novel excipients and suppliers.