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We have a drug with poor solubility and high permeability (but
effluxed back to the gut). Is this a BCS II or IV? Going from Phase
3 to market, what changes in formulations are acceptable without a
formal BE study. For example, a shape change from round to oval, a
logo change, etc. that do not constitute any change in active/inert
ingredients - would these need a BE study? Please send any
references, if available.
Thanks,
Vernon
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The following message was posted to: PharmPK
Hello Vernon
You have not stated why you need to do BE. I believe you are dealing
with NDA. However since you are handling NDA the answer is yes, you
need to do this study. Simply it does not take huge amount of time
and money in the total development program. but if you do not have
this data it may be possible that the product launch may be delayed,
if regulators ask for this data.
Most Probably the regulators will ask you for this data.
With regards
Dr.Prashant
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The following message was posted to: PharmPK
Logo and shape change does not require BE study, but if tablet weight
is changed you have to refer SUPAC guideline for requirement.
Pankaj Gupta
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