ABSTRACT
INTRODUCTION The scope of this chapter will not include biologics for which there are guidance documents on comparability (1), which can include bioavailability (BA) comparisons. The chapter will be concerned with chemical entities for which full marketing authorization applications (MAAs) will be made according to regional or national regulations and ICH guidelines and documentation. (The term “guideline” is used for all the regulatory guidance documents quoted.) The scope will be for such MAAs that will be referred to in this chapter using the U.S. Food and Drug Administration (FDA) nomenclature, New Drug Applications (NDAs), rather than abbreviated or abridged applications for generic drug products, termed ANDAs (Abbreviated New Drug Applications). However, the same bioequivalence (BE) standards are usually applied to the pivotal BE study between clinical trial formulations and the to-be-marketed (or market image) formulations.
