Patent ID: 7996170

Claim:
A method for determining whether the chemical composition of a generic formulation corresponds to that of a reference listed drug, comprising: (a) creating a composite parameter structure corresponding to the reference listed drug by: (i) providing data related to a first sample lot of the reference listed drug and data related to a second sample lot of the reference listed drug to a processor; (ii) using the processor to identify one or more characteristics associated with the first sample lot; (iii) using the processor to identify parameters corresponding to each of the one or more characteristics of the first sample lot; (iv) using the processor to identify one or more characteristics associated with the second sample lot; (v) using the processor to determine whether the one or more characteristics associated with the second sample lot correspond to one or more of the parameters corresponding to the characteristic of the first sample lot; (vi) using the processor to establish one or more additional parameters corresponding to each characteristic of the second sample lot that does not correspond to the parameters corresponding to the characteristic of the first sample lot; (vii) using the processor to provide the additional parameters to an output device; and (viii) using the processor to establish the composite parameter structure as a function of the parameters corresponding to characteristics of the first sample lot and the additional parameters; (b) comparing data related to at least one sample lot of the generic formulation to the composite parameter structure; and (c) determining whether the chemical composition of the generic formulation corresponds to that of the reference listed drug based on the comparison in step (b).