Bioequivalence and Bioavailability Forum

❝ The innovator drug is a capsule containing two population of beads (IR beads and ER beads). Another company develops a drug which is bioequivalent to the innovator (Cmax and AUCs). The product is also a capsule but it contains a single population of beads with IR coating on top of ER Core.

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❝ Is this considered an ANDA filing?

❝ Is this considered an ANDA filing?

Pharmaceutical equivalents means drug products in identical dosage forms that contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, or, in the case of modified release dosage forms that require a reservoir or overage or such forms as prefilled syringes where residual volume may vary, that deliver identical amounts of the active drug ingredient over the identical dosing period; do not necessarily contain the same inactive ingredients; and meet the identical compendial or other applicable applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times, and/or dissolution rates.