Usage of multiple units of the dosage form [Design Issues]
Hi,
If the RLD drug has a strength of 300 mg, and for some reason they weren't available, then, for conducting a BE study of the test 300 mg tablets, can two units of the reference, each of 150 mg tablets, be used.
Is this given in any guideline?
If the RLD drug has a strength of 300 mg, and for some reason they weren't available, then, for conducting a BE study of the test 300 mg tablets, can two units of the reference, each of 150 mg tablets, be used.
Is this given in any guideline?
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Thanks and Regards,
PK
Thanks and Regards,
PK
Complete thread:
- Usage of multiple units of the dosage formPhaneendra.K 2011-05-11 09:02
- Usage of multiple units of the dosage form Helmut 2011-05-11 11:31
