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(d)The estimated average plasma Cmax after single 10 mg XR tablet per day taken in the morning is 105.75 ng/ml assuming an accumulation ratio of Cmax is 1.5 and linear kinetics following multiple dose of lOmg/day. The differences in IR to XR could be large in some subjects if we consider the magnitude of the change in Cmax and tmax from the combination of multiple factors that will affect the PK and/PD (safety) of alprazolam. These factors include, but not limited to, the following: (1) Circadian variation [earlier tmax (on average 1 hour) & higher Cmax (on average +30%) after nighttime dose (note: pivotal clinical trial for XR was done as nighttime administration); (2) Significant food-effect [prolonged (up to 2hours), dose-dependent (significant at higher dose), shortened tmax (on average -34%) & higher Cmax (on average +26%, range: -l2%~+84%)]; and (3) Considerable inter-subject variability (sections 4.5.1.1; 4.6.1). To iterate further, following tests were anybody have hydrocodone performed: (a) The overall average PK parameters (AUC, Cmax and Cmin) at steady-state are similar among three treatments as indicated by the anderson phentermine viagra xanax 90% confidence interval analysis of ratio of test to reference which fell within the goal post of 80- 125% with the exception of the Cmin from 6mg qd, which had been shown to be efficacious in pivotal clinical trial. (b) Pharmacometrics analysis of Cmin using population approach reached similar conclusion (Mishina's review Table 4-6). In addition, the PK/PD model used for the calculation of the probability of decrease in panic attack at the trough plasma alprazolam level for all three treatments fioricet tramadol overlapped. Figure 2 Sponsor's justification of hackeron text buy xanax XR bid Vs qd dosing. Note: The concentrations values from study 0010 (for XR and IR) were multiplied by the ratio of 24-hour AUC values from the IR tablet treatment in study 0002 versus study 0010 (1298ng h/ml: 1514 ng hr/ml). The sponsor indicated that using correction factor was justifiable since different subjects were used in the two studies, so that differences in fioricet tramadol clearance had to be accounted for when comparing the data. The squares (open and closed )denote data from study 0002 and the triangles (open and closed ) denote data from study 0010.

(Note: alprazolam IR=alprazolam CT which represents alprazolam - . Plasma alprazolam concentrations following administration of alprazolam XR tablets once daily (study 0002) and twice daily (study 0010) and alprazolam CT tablets four times daily (studies 0002 and 0010) in healthy volunteers APPEARS THIS WAY (N ORIGINAL Table 4-4 XR 6mg qd (treatment C) Vs IR 1. 5mg qid (treatment D) Parameter Tmt A Tmt B ANOVA Dose 6 mg QD (ASR) 1.5 of phentermine post viagra xanax QID (ACT) p value | AUC*. (ngxhr/mL) 1285 (407)* 1298 (442f 0.6954 Cmax (ng/mL) 70.9 (I7.7y* 70.3 (20.6)4 0.8163 Cmin*.

(ng/mL) 34.3 (17.5) 41.6 (16.4) 0.0001 Cavg (ng/mL)* 53 J (17.0) 54.1 (18.4) J_ Fi* 0.739 (0.240) 0.56 (0.129) 0.0001 Tmax (hr) 6.73 (1.97)4 9.15 (4.58) 0.1999 Clo (L/kg) 5.12(1.64) 3.10(1.60) 0.8859 Clo (mL/min/kg) 1.12 (0.372) 1.11 (0J45) 0.7821 Vd/F (L/kg) 1.15 (0.186) 1.10(0.141)' o.im X (hT') 0.039 (0.017)' 0.06 (0.017)4 0.4384 r* 1.32 (0.125) (f-24) 3.51 (r-5) / / / - r (based on Croay 1.37 (0.318) 3.29 (0.876) - rw (hr) 13.0 (4.87) 12.3 (4.03) - •C**-j - AUC*/24 Table :L6 He&n (± standard deviation) Steady-State (Day s) Alprazolam Pharmacokinetic Parameters Following Administration of Multiple Oral Doses of ASR and ACT Tablets to 20 Healthy Volunteers Parameters Corrected for Mean Assayed Tablet Lot Potency. Table 19 90% Confidence Interval Analysis of Single Dose (Day 1) and Steady-State (Day 8) Selected Alprazolam Pharmacokinetic Parameters. Following the Administration of XANAX 6R Tablets and XANAX CT Tablets to 20 Healthy Volunteers. Parameters Corrected For Mean Assayed Tablet Lot Potency. Parameter Treatment* MSE 9051 C.I. Result Power4 | AUC* (og x hr/mL)' A vs B 2284 85.2-102.0 Pass 97 I Cmax0 (ng/mL)' A vs B 19.8 40.3-62.5 Fail 84 AUC - (ng x hr/mL) C vs D 10,264 94.7-103.3 Pass 99 Cmax (ng/mL) C vs D 70.0 94.3-107.4 Pass 59 Cmin*, (ng/mL) C vsD 16.0 77.2-87.7 Fail Fr* C vs D 0.018 119-145 Fail 70 | *A: Xamx SR 6 mg (2x3 mg) Given as a Single Dose B: Xenix ACT 1.fioricet tramadol 3 mg (1 & 0.3 mg) Given as a Single Dose C: Xanax SR 6 mg Given Every Morning For 6 Days D: Xanax ACT 1.5 mg Given Every 5 hours For 6 Days 4 Power to detect • 20* difference between treatment and reference means at an a level of 0.0S.



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