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Digg It - Two Important Probability Sampling Techniques
Sample, as we know is a part of the population under study. The sample must be the 'true' representative of the population in terms of
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
characteristics possessed by the population elements. It is difficult, actually impossible to draw a true sample from a population. T
; 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
he survey research pro will always try to draw a sample which is as close to 'true' as possible. There are two fundamental types of sa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
pling technique - probability and non-probability sampling techniques. This article tries to illustrate two of the more important prob
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ability sampling techniques.
1. Random Sampling - when all the elements have an equal chance of getting selected in the sample, it is
1. Random Sampling - when all the elements have an equal chance of getting selected in the sample, it is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
termed as random sampling. It works like a lottery system where each ticket has an equal chance of winning. In a way, this method is
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
he most perfect method. However, it is difficult to apply this method for two major reasons - availability of sampling frame (list of
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
population elements) and scatter over the geographical area if the sample is small. Consider for example a population of one million c
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ar owners and survey research pro has to do a sample of 100 from this population. Imagine this sample of 100 from the whole population
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
scattered across the country. On the other hand, if a survey research involving readership of a local newspaper is concerned (and the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
list is available), this method would be the most useful and easy to deploy.
2. Systematic Sampling - as the name suggests this metho
2. Systematic Sampling - as the name suggests this metho
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
d applies a very systematic approach to draw a sample from the population. Suppose a survey research has a population of 10,000 and th
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
survey research pro would like to draw a sample of 200 from this population. First of all divide the population size by the desired s
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
ample size to result is what is known as sampling quotient. In our illustration, the sampling quotient will be 50 (10,000 divided by 2
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
00). Now select any arbitrary number between 1 and 10. Let's say 4 is that number. Now add sampling quotient to this number. The resul
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
will be 54 (4 + 50). Now add 50 again to this number to get 104 and so on. One should keep on adding sampling quotient to the resulta
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
nt number. Thus the sample will consist of person / group / organization number 4, 54, 104 and so on. Main problem faced with this met
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
hod are availability of sampling frame (list of population elements) and its constitution. Constitution will make a huge difference to
.
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
the final sample listing. For example, if names of all the females in a list have a salutation Ms., they will be clustered together. O
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
n the other hand if they are scattered across the list (A to Z), their probability of getting selected in the sample will be different
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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