Summary basis for approval

The next step was to augment and expand the model to be able to predict the dose response for the comparator. Comparator data, from SBA (summary basis for approval data submitted to the FDA), yielded one model that predicted both candidate and comparator performance. The model accounted for age, disease baseline, and trial differences. Differences based on sex, weight, and other covariates were estimated to be negligible. The addition of the comparator data improved the predictive ability of the model for both drugs (Fig. 22.3). 

Source All data for this table was taken from Label, FDA Summary Basis for Approval, and EPAR (European Public Assessment Report) documents. Safety Pharmacology ICHS7. 

Insulin Detemir. Summary Basis for Approval, EPAR, 2006. http //www.emea. europa.eu/humandocs/PDFs/EPAR/levemir/093604en6.pdf... 

Insulin Glulisine. Summary Basis for Approval, Pharmacology Review, 2004. http // www.fda.gov/cder/foi/nda/2004/21-629 Apidra.htm... 

Forsteo. Summary Basis For Approval, EPAR, 2004. http //www.emea.europa.eu/ humandocs/PDFs/EPAR/forsteo/659802en6.pdf... 

Summary Basis for Approval,2000. Antihemophilic Factor (recombinant) Refacto . http //www.fda.gov/cber/sba/ahfgen030600S.pdf... 

All values extracted from the Summary Basis for Approval review posted on http //vrww.accessdata.fda.gov/scripts/cder/ drugsatfda. 

Gender-related data from the FDA are more readily available as the FDA continues to increase its computer ability, and pharmaceutical firms utilize computer-assisted NDAs and increase their efforts to adequately power the studies to find differences. Unified systems and formats would enhance this. The information is included in the Summary Basis for Approval or in the Medical Reviewer s Report. Either should be available through the Internet at www.fda.gov./cder under New Approvals . 

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