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Dear All,
I really like the PharmPK community. Many things to learn from
colleaques here.
1. I want some opinion about Add on subject. Do the regulatory allow
us to add more subjects in the BE study if the power of test is not
enough to tell that the product are equivalence or not? And how we
calculate the number of subject that we should add on , do we need to
calculate from the Intra CV that we get from initail study.
2. Another Question is about power of test. When we do the
statistical analysis of the product and find out the 90% CI is within
the acceptance range but power of test is lower than 80%, in your
opinion what we should do? Do we need to add more subject? Since it
is Type II error , power of test is important to prove false negative
such as inequivalence of the product. Some ones suuget that we
concern type two only when the product are not equivalence. What is
your opinion?
Wichittra
--
Assoc. Prof.Dr. Wichittra Tassaneeyakul
Department of Pharmacology
Faculty of Medicine
Khon Kaen University
Khon Kaen 40002
Thailand
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The following message was posted to: PharmPK
Hi Dr.Wichitra,
You are absolutely right.I agree with your views about PharmPK
community
1.Actually it is necessary to mention in study protocol in advance
regarding add-on subjects
How ever add-on subjects requirement varies from regulatory to
regulatory.If any regulatory
guidance says for add-on subjects,than it can be mentioned in
study protocol and in case of
not achieving Bio-Equivalence criteria,one can use add-on subjects
to achieving
Bio-Equivalence criteria.There is no specific rule regarding
calculation of add-on subjects
actually it completely depends upon what is written in guidance.
2.As per your question that if one is able to lie within Bio-
Equivalence limit but power is less
than 80%,but it does not meant that product is not Bio-
Equivalent.Actually concept of power is
taken in to account to take care of maximum number of subjects
required to achieve
Bio-Equivalence criteria,but it does not impact in concluding Bio-
Equivalence.In fact power of
the test is nothing but probability of corectly concluding Bio-
Equivalence.So dont be confuse
by relating it with Type-II error.
Regards,
Nand Kishore Rawat
Bio-Statistician
Ranbaxy Research Labs.
Gurgaon,India.
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