Significance of Altered Dissolution Properties

Statistical analysis of the data demonstrated that the three generic lots were not only non-bioequivalent to the innovator, they were also significantly different from each other P 0.01). They failed to meet the 80-120% requirement for the 90% confidence limits for the mean AUC and Cmax with respect to the originally launched drug form. 

Detailed analysis also revealed considerable differences in the dissolution of the four tested lots. Lot no. F844-07 dissolved more rapidly than its counterparts, which justified its higher Cmax and AUCq oo values and thereby its clinical effect. Similar clinical effects have also been observed previously with rapidly absorbed carbamazepine tablets in Finland.  

Although the cause of these PK changes have not been determined with certainty, it has at least been partially attributed to the increase in the moisture content of the tablets during storage. The source of the raw materials used, along with their particle sizes, have also been thought to play a role in altering the clinical affect of these lots. 

4 Selection of Solid Form Based on the Therapeutic Condition Case Study of Indinavir 

The effect of the solid form on the PK parameters is also a function of the disease state of the patient. This is well studied and demonstrated in the 

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