(i)For drugs approved elsewhere in the world and absorbed systemically, bioequivalence with the reference formulation should be carried out wherever applicable.  These studies should be conducted under the labeled conditions of administration. Data on the extent of systemic absorption may be required for formulations other than those designed for systemic absorption. 

 

(ii)Evaluation of the effect of food on absorption following oral administration should be carried out.  Data from dissolution studies should also be submitted for all solid oral dosage forms.

 

(iii)Dissolution and bioavailability data submitted with the new drug application must provide information that assures bioequivalence or establishes bioavailability and dosage correlations between the formulation(s) sought to be marketed and those used for clinical trials during clinical development of the product. 

 

(iv)All bioavailability and bioequivalence studies should be conducted according to the Guidelines for Bioavailability and Bioequivance studies as prescribed.

 

Note- The data requirements stated in this Schedule are expected to provide adequate information to evaluate the efficacy, safety and therapeutic rationale of new drugs prior to the permission for sale. Depending upon the nature of new drugs and disease(s), additional information may be required by the Licensing Authority.  The applicant shall certify the authencity of the data and documents submitted in support of an application for new drug.  The Licensing Authority reserves the right to reject any data or any document(s) if such data or contents of such documents are found to be of doubtful integrity.

 

 

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