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Final dissolution method and specification: 1ms 3mx 0.5 mg 1 mg 1 hour 4 hours 8 hours USP apparatus I, lOOrpm, 37°C, volume 500ml, pH 6.0 buffer 4.7.2In vitro and in vivo drug release comparisons 4.7.2.1 Has the sponsor evaluated the relation between in vitro release and the in vivo performance of Xanax XR? Was the IVIVC properly developed and does it demonstrate satisfactory predictability?

Yes, the sponsor attempted to evaluate the relation between in vitro release and the in vivo performance but failed to establish the IVIVC for Xanax XR tablet. However, the sponsor had indicated during the teleconference (03/22/2002).' -" , As a result, the sponsor did not submit the requested individual data and IVIVC was not reviewed. 4.7.3Manufacturing site changes (hydrocodone tamck P/2002/0018) Note: •During the drug development process, there was a/ _ manufacturing site change from Kalamazoo Michigan to Arecibo, Puerto Rico. All the XR tablets hydrocodone tamck used in the PK and clinical studies were manufactured at hydrocodone tamck the Upjohn Kalamazoo facility without debossing. The final commercial production with 2-sided debossing (strength & X) is planned and will be manufactured at Arecibo, Puerto Rico. •The sponsor submitted a BE study (P/2002/0018) comparing highest strength 3mg XR tablet manufactured from Kalamazoo (lot #26,397) and Puerto Rico (lot #26,437) sites.

The existing stability lots made in Puerto Rico in 1991 and 1992 were debossed on one side only (with tablet strength). Ninety-percent confidence interval analysis indicated that tablets manufactured at these sites were BE (90% Cl for Cmax , AUC was 98.0-110.6, 95-108.4, respectively) (Table 4-11), •Previously,; - --r-. ; the sponsor submitted dissolution profiles (pH6.0 & H20) of 3mg tablets made from both sites. For lower strengths (0.5, 1, and 2 mg), only dissolution profiles (pH 6.0 & H20) from Puerto Rico were submitted. This reviewer has performed an f2 test comparing the dissolution profiles between hydrocodone tamck the batches made from new site and the biobatches for hydrocodone tamck PK/BE/pivotal efficacy trial manufactured at the old site.

The dissolution profiles between 2 sites for each strength are similar (£2=50.98~82.9). Table 4-11 Table 44 90% Confidence Interval Analysis difference between oxycontin and percocet (Tvo one-sided Test Procedure) For Comparison of ADC,.., Cmax, and Tmax Following Administration of 3 mg XANAX XR(r) Tablet Sourced from Puerto Rico and D.8. Parameters Corrected For Kean Assayed Tablet Lot Potency.

(ngxhr/mL) B vs A 94.7 - 106.6 95.0- 108.4 Pass Cmax (ng/mL) B vs A 97.1 - 108.2 98.0- 110.6 Pass Tmax (hr) B vs A 31.4-144.8 75.0 - 111.3 Fail *TrcUment A ** (1) XANAX XR Tabtet 3 mg Domestic, Lot 26,319 Treatment B " (1) XANAX XR Tablet 3 mg Puerto Rican, Lot 26,437 *Reference is tbe second treatment for comparison 4.7.3.1 Did the sponsor submit sufficient information to support the - - manufacturing site change? Yes, the information submitted to date --^ -* ) are sufficient to support the - manufacturing site change for all 4 strengths of XR tablets (0.5, 1, 2, and 3 mg).



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