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References in periodicals archive ?
Dalton will provide formulation development, cGMP liquid filling, analytical method validation, quality control release testing and ICH stability services to support of Cerium's drug development program.
Also, in addition to the re-inspection, the company said that the FDA conducted a Pre-Approval Inspection (PAI) for RYTARYTM, as analytical method validation and a portion of the stability data were generated in Hayward and a general Good Manufacturing Practices (GMP) inspection.
After introducing analytical method validation in general, they discuss analytical instrument qualification, high-performance liquid chromatography method development and optimization with validation in mind, method validation basics, robustness and system suitability, setting specifications and investigating out-of-specification results, validation by type of method, analytical method transfer, and implementing new technology in a regulated environment.
Dec 1-2: Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
In addition, USP will offer its Pharmacopeial Education courses on Analytical Method Validation, Basic Statistics and their Practical Applications to USP, Dissolution, Microbiology, and USP 100 and 101.
The term analytical method validation has a variety of meanings to scientists from different disciplines.
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