This webinar will review how dissolution and drug release testing are used to demonstrate the consistency of pharmaceutical product performance within and across batches of critical medicines.

Discussion topics:
– Rigorous development of the USP DPVS
– Potential sources of variability in dissolution testing related to equipment operation and setup
– Risks and implications of relying solely on mechanical calibration or PVT
– Criteria for a “fully qualified” dissolution instrument according to USP specifications
– Impact of choosing an “either-or” approach for mechanical calibration and PVT

Subject area:
Drug Products & APIs

Objectives (If applicable):
N/A

Target Audience (If applicable):
• Pharmaceutical Manufacturers – Companies producing oral dosage form medications, including end-users such as analysts, scientists, and decision-makers at director, manager, and executive (C-suite) levels.
• Regulatory Authorities – Agencies and inspectors responsible for compliance and quality standards in drug development and manufacturing.
• Equipment Providers – Manufacturers and suppliers of dissolution testing instruments and related technologies.