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Dear PharmPK,
We are currently planning a bioequivalence study for a four drug FDC of
anti-tuberculosis agents. We have had a query from the regulatory
authorities with respect to the choice of comparator products -
specifically the factor used to scale the drug levels seen in the test
product.
The reference products are not available in dosages where the final the
dosage delivered by the FDC will be matched exactly. In sourcing the
comparators, we have attempted to match them as closely as possible,
However, in doing so, we are necessitating the use of a factor for
adjusting the resulting drug levels of the test product slightly. For
instance, the one factor is 0.9375 and the other is 1.091.
Does anyone have any views on the use of this factor - supported by
references?
Thanks.
Jennifer Norman
Quality Assurance
Division of Pharmacology
K45-68 Old Main Building
Groote Schuur Hospital
Observatory, 7925
SOUTH AFRICA
Tel. +27 (0)21 406 6498
Fax. +27 (0)21 448 1989
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dear jennifer,
i just finished a study related to the subject,
however, i analysed only the rifampicin component of
the FDCs as is required by the WHO (for the other three
i.e. INH, RYZ and ethambutol, dissolution data is
enough). you are sure to get the information you
require from R. Panchangnula (panchagnula.at.yahoo.com) or
search for his publications on elsevier.com as he has
worked on all the four components. you are sure to get
some material from there.
wajahat mahmood.
Amson Vaccines& pharma. (pvt.)ltd.
pakistan
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The following message was posted to: PharmPK
Dear Jennifer,
Any reply to your question. Better to pose this question to WHO, Geneva.
Rakesh Chaurasia
Dy. General Manager-Drug Regulatory Affairs
Macleods Pharma-Mumbai-India
chaurasiarakesh.-at-.rediffmail.com
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