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Can someone explain to me exactly how to calculate the F2 using the
example given by Stephan Ortiz in this discussion. Thanks in advance.
Hina Dave
Operations Manager
Phillips Pharmaceuticals Ltd
P. O. Box 46662 - 00100 GPO
Nairobi
Kenya
Email: hina_dave.aaa.phillipspharma.com
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Hi,
instead of F2 method, I recommend you to use the method described in
our study
Dedik, L., Durisova, M. System-approach methods for modeling and
testing similarity of in vitro dissolutions of drug dosage
formulations. Computer Methods and Programs in Biomedicine, 69,
2002, 49-55. (Abstract and text) . The method is capable of testing
similarity of both: the extent of drug dissolved and the rate of
dissolution. The method is exemplified using the data from the study
Shah,V.P. et al., Pharm.Res. 15 (1998) 889-896. Pros and cons of the
described method and the F2 method are discussed.
With best regards,
Maria Durisova
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To determine f1 value how many number of time points should we
consider, if reference product is releasing 7% in 60 minutes
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The following message was posted to: PharmPK
Theoretically 12 units should be used for each profile determination .
For sustained release products at least seven time points should be
examined.
For immediate release around four are enough. Do select the time
points wisely to ensure that the data is well spread for easy
interpretation of the kinetics of drug release
s.o.o
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