SUPAC

AcronymDefinition
SUPACSupplemental Post Approval Changes
SUPACSouthwest Utah Planning Authorities Council
SUPACSyracuse University Parent Advocacy Center (New York)
SUPACScale-Up and Postapproval Changes
References in periodicals archive ?
He is the past chairman of ISPE's SUPAC Equipment Guidance Steering Committee.
No tailing off in API release at the end of the dosing interval; -- Cost effective/ Low cost of formulation and development and manufacturing; -- Reduced time from bench development to manufacturing--easy SUPAC site transfers -- CDT processing that is not equipment dependent and requires no specialized equipment or processing; -- Employs all GRAS (Generally Regarded As Safe) excipients already FDA approved for use in pharmaceuticals; -- Two step processing--dry blend and direct compression; -- Easily identifiable and controllable criticality in blend uniformity.
Zero-order kinetics (linear release) are achievable; -- No tailing off in API release at the end of the dosing interval; -- Cost effective/Low cost of formulation and development and manufacturing; -- Reduce time from bench development to manufacturing -- easy SUPAC site transfers -- CDT processing is not equipment dependent and requires no specialized equipment or processing; -- Employs all GRAS (Generally Regards As Safe) excipients already FDA approved for use in pharmaceuticals; -- Two step processing -- dry blend and direct compression; -- Easily identifiable and controllable criticality in blend uniformity; -- Requires standard processing equipment widely available throughout the pharma industry.
ISPE and FDA collaborations have included the SUPAC equipment addendum listing for which both the Agency and ISPE were awarded the Hammer Award by former Vice President Al Gore's office, and the production of the Baseline(R) Pharmaceutical Engineering Guide Series.
PDx-IVIVC brings together the very latest tools and approaches, for effective decision-making during formulation development and the lifetime of a product, including SUPAC changes and biowaiver requests.