Bioavailability and Bioequivalence

Ajit S. Narang; Ram I. Mahato

doi:10.1016/B978-0-323-99796-6.00004-7

Bioavailability and Bioequivalence

Research output: Chapter in Book/Report/Conference proceeding › Chapter

Abstract

This chapter discusses the background, concepts, and methodology for the assessment of bioavailability (BA). It also discusses various factors affecting BA, which include drug substance-related, dosage form-related, and physiological parameters. Finally, the chapter addresses the concepts of bioequivalence (BE), study design, data interpretation, and criteria for the assessment of BE.

Original language	English (US)
Title of host publication	Pharmaceutics
Subtitle of host publication	Basic Principles and Application to Pharmacy Practice, Second Edition
Publisher	Elsevier
Pages	517-535
Number of pages	19
ISBN (Electronic)	9780323997966
ISBN (Print)	9780323997973
DOIs	https://doi.org/10.1016/B978-0-323-99796-6.00004-7
State	Published - Jan 1 2023

Keywords

Area under the curve (AUC)
Bioavailability (BA)
Bioequivalence (BE)
Drug absorption
In vitro-in vivo correlation (IVIVC)

ASJC Scopus subject areas

General Medicine
Pharmacology, Toxicology and Pharmaceutics(all)

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10.1016/B978-0-323-99796-6.00004-7

Cite this

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AB - This chapter discusses the background, concepts, and methodology for the assessment of bioavailability (BA). It also discusses various factors affecting BA, which include drug substance-related, dosage form-related, and physiological parameters. Finally, the chapter addresses the concepts of bioequivalence (BE), study design, data interpretation, and criteria for the assessment of BE.

KW - Area under the curve (AUC)

KW - Bioavailability (BA)

KW - Bioequivalence (BE)

KW - Drug absorption

KW - In vitro-in vivo correlation (IVIVC)

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EP - 535

BT - Pharmaceutics

PB - Elsevier

ER -

Bioavailability and Bioequivalence

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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