Bioequivalent drug products

Bioequivalent drug products are pharmaceutical equivalents whose bioavailability (i.e., rate and extent of systemic drug absorption) does not show a significant difference when administered at the same... 

Bioequivalent drug products are products that are pharmaceutically equivalent that provide the same results of drug delivery with the same pharmacokinetic properties. 

Bioavailahility studies are used to compare different formulations of the drug product, or different batches of the same formulation and, as discussed in Chapter 8, generic copies of a reference drug. Their comparative value is based on the premise that, if similar amounts of identical active substance are delivered to the site of action at similar rates, then a similar biological response can be expected, which leads to the conclusion that the two preparations are bioequivalent. 

The topic of generic bioequivalence pertains to the relative bioavailability of different versions of the same drug product, all of which may be available in the marketplace at the same time. Thus, if we continue our consideration of the example introduced in the previous section of this chapter, let us suppose that the innovator did obtain approval to market F3. Initially F3 was the only product available in the marketplace. However, when the relevant patents held by the innovator have expired, other pharmaceutical... 

III. ROLES OF VARIOUS ENTITIES IN ASSURING BIOEQUIVALENCE OF DRUG PRODUCTS... 

The United States Pharmacopeia (USP) (or other national or regional pharmacopeia) provides standards for a large number of drug substances and drug products. Some of these standards are particularly relevant to bioequivalency. First, USP products are... 

As indicated in previous sections of this chapter, there has developed a quite impressive international consensus on the general principles of bioequivalency determination for drug products regulated by agencies such as FDA. However, there are other materials used with therapeutic intent for which bioequivalency may also be a legitimate concern. Herbal remedies have, in recent years, demonstrated impressive increases in sales in many parts of the world. Other substances of natural origin have gained considerable attention for their possible curative potential. For example, shark... 

C. T. Rhodes, Bioequivalence studies for veterinary drug products, Clin. Res. Drug. Affairs, 9, 1 (1992). 

The growth of generic prescribing and generic substitution will clearly increase the role and responsibilities of pharmacists in drug product selection. This movement will also stimulate in many regions of the world further debate about how bioequivalence should be quantified and when in vitro methods may, in some... 

The FDA currently allows biowaivers (27) (drug product approval without having to show bioequivalence in vivo) for formulations that contain Class I drugs and can demonstrate appropriate in vitro dissolution (rapidly dissolving). 

Stippler E. Bioequivalent dissolution test methods to assess bioequivalence of drug products. Ph.D. dissertation, Johann Wolfgang Goethe University, Frankfurt am Main, 2004. 

Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations. Oct. 2000. 

FDA. Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (Revised) (I). Rockville MD, USA U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2003. 

Stippler E. Biorelevant Dissolution Test Methods to Asses Bioequivalence of Drug Products. Frankfurt Institute for Pharmaceutical Technology, J. W. Goethe University, 2004 414. 

---