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Hossain recommended the approval of this manufacturing site change. Following are the bases for vthe;approval of the) ^manufacturing ibuprofen tramadol site change: (1)BE was demonstrated for highest strength of XR tablet (3mg) made from the old site and new site.

Ninety-percent confidence interval for the log-transformed PK parameters (Cmax & AUC) fell within ibuprofen tramadol the recommended goal post (80-125). (2)XR tablets manufactured at old site demonstrated dose-proportionality and dose-strength bioequivalence.

Additionally, based on the SUP AC guidance published recently for modified-release solid dosage form, this reviewer has incorporated following information to support granting the biowaiver for remaining three lower strengths XR tablets (0.5, 1, and 2 mg): (3)Following dissolution profiles between the old and new sites are similar (f>50): (a) the highest strength 3mg (in water & pH6.0 phosphate buffer), and (b) three lower strengths XR tablets (0.5, 1, & 2mg) in pH6.0 phosphate buffer. This reviewer performed an £2 test comparing dissolution profiles between the old and new sites.

The results are summarized in table below (Table 4-12). Note: 3mg XR tablet made in new site was not the biobatch used in the BE study comparing 3mg XR tablets made at old and new sites. Table 4-12 Dissolution profile comparison for 3 lower strengths XR tablets (0.5,1, and 2 mg) manufactured at the new and old sites 0.5mg lmg 2mg 3 mg Lot# (old site) Lot# (new site) "". 36 4.7.4 Debossing issues 37 the dissolution profiles similar between debossed and non-debossed tablets using the selected dissolution method for all strengths (0.5,ibuprofen tramadol 1,2, and 3 mg) of Xanax XR? 37 4.8ANALYTICAL SECTION 38 4.8.1 Which analytical methods were used in the plasma analyses?

[Hossain's review; protocol P/2002/0017 (Chou's review)] 38 18 years of age). The sponsor is seeking approval of XR product based on the ELV/BE studies, one positive clinical trial of XR. product, and PK/PD relationship established with IR product.

i _- ) regimens for the XR tablet for the treatment of panic disorder. At the pre-NDA meeting, the Clinical Di vision informed the sponsor, dosing regimen for XR will be acceptable if plasma profiles of XR L| ._ l are completely bracketed by XR (qd) and IR (approved dosing regimen) since the pivotal efficacy trial for Alprazolam XR tablet was carried out with a once daily regimen. The sponsor also requests a deferral of pediatric studies in adolescent panic disorder patients. According to the sponsor, the biopharmaceutic/pharmacokinetic/pharmacodynamic development program for alprazolam XR tablets was designed to accomplish the following objectives: (1) establish the comparable extent of alprazolam absorption between the XR tablets and the IR tablets and document the prolonged absorption from alprazolam XR tablets, (2) demonstrate comparable peak to trough alprazolam concentration ratios for the two formulations, (3) document the biopharmaceutic performance of the XR formulation and the influence of food on its bioavailability, (4) establish an in vitro-in vivo correlation for alprazolam XR tablets, and (5) assess whether the slower release rate from alprazolam XR tablets had an effect on the pharmacodynamics of the compound.

While 23 studies were conducted in this Clinical Pharmacology and Biopharmaceutics program, full analyses of 21 studies are submitted. The analysis of pharmacokinetic/pharmacodynamic data from two studies (M/2002/0044 & M/2002/0037) were not included in this application. Only safety data from these 2 studies were summarized since the sponsor felt that due to the design of this study (sequential shift from immediate release to XR tablets) and its relatively short duration (4 days on each formulation), little additional knowledge would be derived from analyses of these data. A total of 8 phase II/III clinical studies were conducted with alprazolam XR formulations in ibuprofen tramadol patients with panic disorders. The sponsor has indicated that study M/2000/0369 is the pivotal efficacy trial. Plasma samples for drug analysis were collected in clinical trials M/2002/0369(#4452) & M/200/0271 hydrocodone street price (#4438). The sponsor indicated that blood samples from studies 4438 and 4452 were collected to assess compliance, and sufficient dosing and sample collection time information was available to support population pharmacokinetic analyses.

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