Prior to seeding the cells into the

Prior to seeding the cells into the inserts, the wells should be filled with media.The media volumes for the different well sizes are listed below:Well Volume(mL)Change media 24 hours later to remove dead cells and cell debris.All manipulations of the cells must be written into the appropriate notebook.Removed reference to specific SOP versionsMay 29, 2006 Procedure for Preparation of Cell MonolayersSummary ofBiopharmaceutic Studies and Associated Analytical MethodsThe formulation of Buspirone Hydrochloride Tablets USP was selected based on the formulation of the innovator, Buspar ® Tablets(manufactured by Bristol-Myers Squibb Company; NDA 018731), which was the reference listed drug(RLD)during development.Based on compatibility studies and desired characteristics of the drug product, the levels of excipients selected for formulation development of Buspirone Hydrochloride Tablets USP are supported by the levels included in the Agency's Inactive Ingredient Database.