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Digg It - Test Campaign Result Accuracy Test Group Sizing Part II
An approach to size test groups for a campaign has been presented in [Test campaign result accura
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
cy test group sizing Part I]. However, how can one be sure that the size of the customer grou
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
used (the sample), is sufficient to provide statistically accurate results. Having carried out a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
test campaign on a sample (customer group) of a given size, one can estimate the range of the ex
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ected response rate.
If the test campaign has been run on a group of size N and the response rat
If the test campaign has been run on a group of size N and the response rat
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
measured was p, the standard deviation is calculated by the following formula SEP = SQRT(p*(1-p)
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
/N) . For example if the group size N has been 60 thousand and the response rate p was 4 %, then
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
the standard deviation (SEP) is 0,08%. This means that one can be 68% confident that the response
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rate will range between 3,92% and 4,08% (within one standard deviation) or 95% confident that it
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
will range between 3,84% and 4,16%. (the confidence level of 95% is the probability to fall withi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the response rate range and is found approximately 2 standard deviations from the mean).
As can
As can
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
be understood by the formula above, the larger the size N of the group, the smaller the standard
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
deviation and the narrower the confidence internal. Using larger groups (larger samples) leads to
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
higher confidence in the evaluation made. Up to this point, we have discussed the case of a sing
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
e test group.
What if a test campaign aims at the comparative evaluation of two alternative cust
What if a test campaign aims at the comparative evaluation of two alternative cust
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
omer selection models in order to identify the model which has higher predictive power. In that c
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
se, the test yields two response rates of the two test groups used. If the response rates differ
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ubstantially than the conclusion is clear. However if the two results are located close to each o
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ther, then the confidence intervals may overlap, thus leading to no clear conclusion. In that cas
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
, one should calculate the confidence interval of each group in order to check if the two overlap
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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