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Dear All
I am interested in finding out whether there is a waiver in
bioequivalence given for combination products (eg ibuprofen and
chlozoxazone, or other combinations where the drugs combined are old
molecules) However, we wish to combine them into a single doage form.
Is there any clause in the FDA site for such kind of waiver in
bioequivalence. Is there a site which gives the list of drugs which
does not require bioequivalence studies. If possible guide meto the
websites which quotes all types of waiver possible.
Thanking you,
Regards.
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The following message was posted to: PharmPK
Dear Dr. Simmy Veliyil ,
Referring to your question specifically with respect to Immediate
release dosage forms, generally it is possible to get biowaiver for the
lower strengths for combination products also.if the formulations are
dose proportional and the both drugs shows linear kinetics in the
dosing range covered by lowest to highest strength (and drugs are not
Highly variable Drugs( HVD)).You can refer to the example of Losartan
and Hydrochlorthiazide Oral Tablets in FDA's orange book ( 100+25 mg &
50+12.5 mg).
The suitability of this case for the biowaiver based on BCS (
Biophramaceutical classification System)is largely dependent on the
class of individual drugs ( whether both class I ?)and effect of one on
the absorption of other.
I hope this answers your querry.
Kind Regards,
Pradeep S. Bhaduria
RANBAXY RESEARCH LABORATORIES
INDIA.
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