**5. Conclusion**

The concept of bioavailability and bioequivalence studies has been adopted by the pharmaceutical industry and national regulatory authorities throughout the world over 20 years. It is mainly due to increasing the number of generic drugs and its formulations and marketed after regulatory acceptance. So, the bioavailability and bioequivalence studies carried under stringent protocols and modified according to the needs. Pharmacokinetic parameters are evaluated by the statistical

**79**

**Author details**

Divvela Hema Nagadurga

provided the original work is properly cited.

*Bioavailability and Bioequivalence Studies DOI: http://dx.doi.org/10.5772/intechopen.85145*

formulations.

methods to get accurate results to assure high quality interchangeable and affordable drugs. There is a continuing attempts made by different organizations, authorities, and basic scientists to understand and develop more efficient and scientific valid approaches to evaluate bioavailability and bioequivalence studies of various

© 2019 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,

Avanthi Institute of Pharmaceutical Sciences, Visakhapatnam, India

\*Address all correspondence to: mylabathulah@gmail.com

*Bioavailability and Bioequivalence Studies DOI: http://dx.doi.org/10.5772/intechopen.85145*

*Pharmaceutical Formulation Design - Recent Practices*

described above.

tal approach.

product [27].

**5. Conclusion**

formulations where required to administer the formulations after an appropriate meal at a specified time before taking the drug to know the food effect. Food effect study requires the same statistical evaluation as the fasting study as

Most bioavailability studies, whether for a new or generic product, are carried out for the common theme. These studies are conducted to identify the quantitative nature of a specific product comparison. The absolute bioavailability of new drug is used to assess the pharmacokinetic parameters of an oral formulation relative to that of an intravenous dose or performance of a modified release formulation in comparison to a conventional capsule. For a generic product, it is mainly done for comparison of a competitive formulation with a reference or standard drug. Such commonality in comparative bioavailability studies suggests a universal experimen-

Comparative bioavailability studies for new drug are used to conduct to determine the bioavailability and bioequivalence of the formulation in humans for safety and efficacy. Information about bioavailability of new drug formulation is obtained by comparing the pharmacokinetics parameters of an intravenous and oral admin-

When a manufacturer wishes to gain therapeutic equivalence for introducing a competitive generic product into the market place, it is not necessary to conduct the full batch of clinical trials needed for the first product. If therapeutic equivalence has been determined, study has to be carried out according to prescribed study requirements, and it should be similar or equivalent to the previous or innovator product. This is regarded as therapeutically equivalent to the innovative drug

When the particular drug is not showing any expected results under fasting conditions, then the drug can also be tested under fed conditions to meet all conditions

The concept of bioavailability and bioequivalence studies has been adopted by the pharmaceutical industry and national regulatory authorities throughout the world over 20 years. It is mainly due to increasing the number of generic drugs and its formulations and marketed after regulatory acceptance. So, the bioavailability and bioequivalence studies carried under stringent protocols and modified according to the needs. Pharmacokinetic parameters are evaluated by the statistical

**4. Importance of bioavailability and bioequivalence studies**

**4.1 Universal approach about comparative bioavailability**

**4.2 Comparative bioavailability studies of new drugs (NDA)**

istration of new drug formulations having the same dose [26].

**4.3 Comparative bioavailability of generic drugs (ANDA)**

**4.4 Testing under fasting conditions or fed conditions**

as per regulatory norms in bioequivalence studies.

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methods to get accurate results to assure high quality interchangeable and affordable drugs. There is a continuing attempts made by different organizations, authorities, and basic scientists to understand and develop more efficient and scientific valid approaches to evaluate bioavailability and bioequivalence studies of various formulations.
