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(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 overlapped.

Figure 2 Sponsor's justification of XR bid Vs qd dosing. Note: The concentrations values from study 0010 (for XR and IR) were multiplied by diet pill xanax 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 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 hydrocodone message boards 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 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 CJo (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 (hr1) 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 (hydrocodone message boards 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 hydrocodone message boards 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 1.3 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. *Fluctuation ratio *" (Cmax-Cmin)/Cavg *Normalized to a l.S oa dose. r " l/(l-e4') 4 Sa^ic do>" parameter ss Tible 17 ii signifrantly different from iteady-itate parameter, p 99.9 Cmax (ng/mL) D va C 56.1 96.0-107.0 Pass 99.97 } Cmin*, (ng/mL) D vs C 66.5 89.2-109.0 Pass 90.8 1" , D v* C 0.0232 73.8-106.0 Pail 52.0 *A: Xanax.ACTI.S mg (1 &. 0.5 mg) Gives as a Single Dose B:0Citixx;SR-r3 mg-Givea as a Single Dose C: Xanax ACT 1.5 mg Given OID (Every 5 hours) For 6 Days D: Xanax SR^3 mg Given;- • 'Every Morning) For 6 Days *Power to detect a 20 X difiereace between treatment and reference means at an a level of 0.05. *Fluctuation ratio - (Cmax-Cmin)/Cavg *Normalized to a l.S mg dose. Table 4-6 Comparison of the observed plasma concentrations measured at trough and calculated effects of alprazolam in studies 0002 and 0010. Study 0002 0010 Regimen IR 1.5 mg QID XR 6 mg QD IR 1.5 mg QID XR 3 mg BID Cmin, ng/mL Mean (SD) 47.02(17.hydrocodone message boards 42) 36.35 (17.7) 55.28(25.12) 57.5 (25.73) Range - .



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