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BE was demonstrated in the highest strength (3mg) made from both sites.

•Dissolution profile comparisons regarding debossing issues for the final-to-be marketed formulation: neither clinical nor biopharmaceutical studies were conducted using to-be-marketed 2-sided debossed tablet. In summary, following information were not reviewed: f tramadol online •Proposed pediatric development plan: These protocols will be reviewed when the Clinical Division makes a decision whether or not to grant the deferral of pediatrics studies •IVIVC: The sponsor had indicated during the teleconference (03/22/2002) that since bitrate hydrocodone the IVIVC development was not successful, f tramadol online they are not using IVIVC to help set dissolution specifications and has . Therefore, requested individual data were not provided by the sponsor. •Abuse liability (P/2002/0008), PK/PD in healthy volunteers [(M/2002/0020 (f tramadol online proof of concept), M/2002/037, M/2002/0044)]. Data from the latter two studies were neither provided nor analyzed by the sponsor. PK/PD proof of concept study was not reviewed since it can not be interpreted meaningfully for the following reasons: (1) Studies did not include control group. (2) Only healthy volunteers were enrolled in the studies to evaluate the relationship between alprazolam plasma concentrations and side effects (psychomotor performance and sedation). (3)Psychomotor performance was evaluated with the digital symbol substitution test (DSST) and card sorting tasks after single and multiple doses. The psychomotor performance was neither measured in clinical studies nor correlated with the clinical efficacy or safety measures. Overall, following conclusions regarding the BA/BE, exposure-response relationships, pharmacokinetics, and biopharmaceutics have been made regarding the alprazolam XR formulation: •The sponsor did not properly investigate the PK/PD relationship in the target patient population using clinically relevant endpoint(s) for XR tablet. Overall, neither alprazolam plasma concentration after administering IR tablet was related to control of panic attacks nor the alprazolam dose can be used to predict the treatment for an individual patient. •Tolerance (both acute and chronic) to the sedative effects has been observed from alprazolam treatment.

This phenomena is independent of route of administration or formulation (iv, IR, XR) or dose (IR 1.5 mg ; XR, 1, 3, 4, 6, 8 or lOmg). •The conclusion of the same efficacy and safety of both formulations (IR and XR) may be controversial even though f tramadol online the PK profiles as well as the calculated PD effects for alprazolam obtained . after the administration of IR (1.5mg qid) and XR (3mg bid, 6mg qd) formulation are similar. The results from the data analysis of undesired effect such as adverse events were inconsistent when comparing across the IR (qid) and XR(qd) tablet treatment groups in clinical trials. •The PK of alprazolam and two of its minor active metabolites (4-hydroxyalprazolam and a- hydroxyalprazolam) are linear and concentrations are proportional to dose up to the maximum recommended dose of lOmg a day. In addition, XR tablet follows linear kinetics with multiple doses up to 6mg a day. • Studies comparing single dose and steady-state kinetics of alprazolam after administration of both IR and XR tablets indicated that the there is a reduction in absorption rate (lower Cmax and longer tmax) .

which is to be expected from the extended release formulation. Other PK parameters remained comparable: extent of absorption (order cheap tramadol AUC), distribution (Vd/F), metabolism (AUC ratio of parent:metabolite), or elimination (tl/2 & Cl/F) of alprazolam. • The strength equivalency between the 0.5mg XR tablet given as a lmg dose and the 1 .Omg XR tablet has been demonstrated.

The strength equivalency between the 1.0, 2.0, and 3.Omg XR tablet given as a single oral dose of 6mg of alprazolam has been demonstrated. • From the Clinical Pharmacology and Biopharmaceutics perspective, the pharmacokinetic parameters (the overall AUC, Cmax, and Cmin) following the twice daily (bid) dosing are bracketed by those from XR (qd) and IB.



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