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Over a long period of two decades in the capacity of academician and practitioner of survey research and survey analysis, I have seen my students and executives fe

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

ar one thing for sure - survey analysis. Anything having remote connection to statistics is like reading a death sentence. I on the other hand, found life there.

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

n experienced survey analysis pro will essentially do it at three levels - analyzing one variable at a time, two at a time and more than two at a time. When one do

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s two variable analysis at a time, it is called bivariate analysis, while that for more than two variables at a time is termed multivariate analysis. It would be

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

consolation to be aware of the fact that most of the survey analysis deals with single variable or two variables. Multivariate analysis finds its application on r

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

re occasions. I do not mean to say that they are not important or not useful, but not found in practice.

Single variable analysis means one is dealing with one va

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

riable at a time. One employs techniques like tabulation which includes frequency and percentage. In some cases, central tendency measures like mean, mode and medi

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

n too are employed.

Frequency means number of occurrences of a particular attribute - for example, one may report the gender split of a sample in a survey analysi

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

. If there are 45 males who have taken part in a sample of 100, this will be termed as frequency of male participants. When expressed in percentage, it will 45% of

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

the sample. When sample sizes are large enough (how to define a 'large' sample - that's a huge science in itself; we would consider 100 as reasonably large), the s

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

rvey analysis reports contain percentage as a way of reporting. Such frequency reporting is called tabled data or tabulated data. The moment, there is something ca

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

lled cross-tabulation, it would mean two or more variables.

Almost all the variables (questions in the questionnaire) in a survey analysis are reported through a

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ingle variable table. You would generally find tables of age, income, gender, occupation, etc as a part of demographic reporting. In a shopping mall study, the att

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ibutes like number of times shops visited, amount of grocery purchases, etc are reported through tables like these.

At times, it becomes important to specify the

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ost representative figure of the findings - for example, average bill of mobile phone or average number of shops visited before buying furniture. Whenever such a '

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

entral figure has to be reported, one deploys mean, mode or median. All the three are 'averages' in a sense, but with different meaning. Mean as an average is more

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

useful when one wants to have a mathematical figure. For example, average number of footfalls each day over a month - mean will be most useful here. Mode is used

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

hen one doesn't really want to have a feel of mathematical average like mean - for example, colors most preferred by you while shopping. Thus, red and green may co

.

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

e out to be the ones with maximum frequencies. We would call red and green colors to be the main 'modes'. Median is used when there is continuity of data - for exa

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ple, age or income of the respondents. When data is continual in nature, mean may lead to misleading conclusions. So, median is used in such survey analysis tables

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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