Is Bioequivalence Studies required on all products?
No. Only products that are included in the List B’ (prime) are required by the Bureau of Food and Drugs (BFAD) to submit Bioequivalence Studies. List B’ (prime) products usually exhibit problems with solubility and absorption hence requires bioequivalence. These products are compared to the reference or originator drug. These products are: metoprolol, nicardipine, nifedipine, phenytoin, propanolol, pyrazinamide and theophylline.
