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Understanding Biopharmaceutics Properties for Pharmaceutical Product Development and Manufacturing I—
Oral Absorption and the Biopharmaceutics Classification System
Authors: Deliang Zhou and Yihong Qiu
“Product and Process Design” discusses scientific and technical principles associated with pharmaceutical product development useful to practitioners in validation and compliance. We intend this column to be a useful resource for daily work applications. The primary objective for this feature: Useful information.
Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Please send your comments and suggestions to column coordinator Yihong Qiu at qiu.yihong@abbott.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.
KEY POINTS
The following key points are addressed in this article:
• Bioavailability refers to the rate and extent of a therapeutically active drug that reaches the systemic circulation, thereby accessing the site of action
• Bioavailability of an oral dosage form may be understood from three perspectives: Anatomical and physiological features of the gastrointestinal tract, physicochemical properties of the drug molecule, and physicochemical properties of the dosage form
• In vivo dissolution and gut wall permeation are two critical sequential steps before a drug enters the general systemic circulation
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