Setting specifications for new oral products can be challenging. Too lenient, and there is a risk of passing batches of inadequate quality; too stringent, and there is a risk of rejecting acceptable batches.
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Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…