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USFDA/EMEA/CANADA/Japan/WHO guidelines on BioEquivalence (Part-2)

Criteria for Reference Product (RP)

3 lots of innovator products (for each lot 6 unit/+) dissolution tests should be perform by paddle method at 50 rpm.

The innovator lot showing intermediate dissolution should be selected as the reference product.

When the average dissolutions of the 3 lots reach 85% within 15 min, any lots can be used as the reference product.

If RP can’t be selected by dissolution testing > a substitute physicochemical test is performed > choose the RP with intermediate characteristics.

If the drug is administered as a liquid where the active ingredient dissolves > no dissolution tests is required > an appropriate lot can be used.

Packaging of study products

The reference and test products should be packed in an individual way for each subject and period, either before their shipment to the trial site, or at the trial site itself.

Packaging (including labelling) should be performed in accordance with GMP.

It should be possible to identify unequivocally the identity of the product administered to each subject at each trial period.

Packaging, labelling and administration of the products to the subjects should therefore be documented in detail.

This documentation should include all precautions taken to avoid and identify potential dosing mistakes. The use of labels with a tear-off portion is recommended.

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