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What is focus group?

Focus group is basically a group interview that comprises targeted respondents (usually 8

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

to 10 participants) and a moderator. The purpose of focus group is to gather/obtain opinions and insights on issues of

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

Examples of combination products may in

interest to the researcher. The moderator is responsible for leading the discussion in a non-structured and natural man

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

ner.

Know-It! in dealing with focus groups

1. Select or create a suitable-good setting

Always select an envir

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

onment that doesnt project the "classroom" type of feeling or any uneasy/stressful feeling. Holding a focus group sessi

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

Combination pro

n in a suitable environment ensures that respondents are able to express their opinions/insights freely, precisely and

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

without being affected by the environment.

2. Recruit good respondents

Select the best of the crop. Make sure that re

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

spondents fulfill each and every requirement of the focus group and more importantly, they must be able to express them

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

selves freely and accurately. They must be somewhat outspoken and do not constantly give answers such as "dont know" or

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

"no comment"

3. Assign a good moderator

It is very vital to have a good moderator to lead the discussion group. The

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

oderator must be able to "connect" with the respondents and not give the "teacher-student" type of relationship during

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

Following aspects would a

the session. The moderator must also be aware of the respondents who arent contributing sufficiently and try to get the

dd to the challenges in developing combination products:

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

m more involved. A good moderator will remind the respondents that their opinions have no "right or wrong" from time to

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

time. The moderator must avoid being bias, making too much facial impressions and body languages. He/she must always p

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

roject the impression that he/she is keen to hear about the respondents' opinions and not judging whether they are righ

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

or wrong.

4. Prepare the outlines of the focus group

The outlines of the focus group is essential in ensuring that t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he target & objective are achieved. It should serve as proper guidelines to the moderator, in leading the focus group.

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

The outlines is usually divided into 3 phases.

5. Conduct the focus group

Moderator must establish rapport with the g

.

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

roup, state the rules of group interaction, remind the respondents that there are no "rights & wrongs" in expressing op

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

Companies that provide selfless information through particip

inion etc. It is necessary for the moderator to set the right mood from the start to the end of the focus group session

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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