Answer / balaji n

Dissolution profile means
collecting samples at different time points while
performing dissolution with respect to the nature and type
of formulation(IR,SR,MR etc).

Dissolution profiling will help you to find the
discreminating power,samness with innovator sample and also
as reference during other investicational studies.

Dissolution profile comparison
1. For accepting product sameness under SUPAC-related
changes.
2. To waive bioequivalence requirements for lower strengths
of a dosage form.
3. To support waivers for other bioequivalence requirements.

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From where require to take the RLD sample?

0 Answers  

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