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It is a skill developed over time and subject to constant improvement. Four general guidelines are useful to bear in mind during the wording and sequence of each question posed in the data acquisition proc

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

ess.

(1) The wording must be clear: If the researcher decides that a question is absolutely necessary, that question must be stated so that it means the same thing to all respondents. Ambiguous terminolog

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

Examples of combination products may in

should be avoided, such as "Do you live within five minutes of here?" or "Where do you usually shop for clothes?" The first example depends on the mode of transportation (maybe the respondent walks), driv

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

ng speed, perceived elapsed time and other factors. It would normally be prudent to show the respondents a map with certain areas delineated and ask if they live within the area. The second question depen

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

s on the type of clothing, the occasion, the member of the family and the meaning of the word where.

Clarity also implies the use of reasonable terminology. A questionnaire is not a vocabulary test. Jarg

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

Combination pro

on should be avoided and verbiage should be geared to the target audience. Every prospective respondent represents a separate frame of reference. That is, each person is unique in personality, mental abil

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

ty, experiences, education and views of the world. Therefore, the questionnaire designer must use terminology native to the target respondent group and not to research jargon. The first task of wording qu

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

stions, then, is to translate questions into everyday language.

(2) Select words as to avoid biasing the respondent: A question such as, "Do you often shop at lower class stores like K-Mart?" evokes an obv

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

ous response. Similarly, "Have you purchased any high-quality Black and Decker tools in the past six months?" also biases respondents. Questions can be leading, such as, "Weren't you pleased with the good

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

service you received last night at the Holiday Inn?" These examples are quite obvious. Unfortunately, bias may be much more subtle than is illustrated in these examples.

Sponsor identification too early

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

in the interviewing process can also distort the data acquisition process. It does not take long, for example, for a person to recognize that a survey is being conducted for Miller beer if, after the third

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

Following aspects would a

question, every question is related to this product. Similarly, an opening statement such as, "We are conducting a study on the quality of banking for Northeast National Bank and would like to ask you a fe

dd to the challenges in developing combination products:

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

questions" can influence responses. Sometimes, of course, the true purpose of the study must be disguised to obtain an unbiased response.

(3) Consider the ability of the respondent to answer the question

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

: in some cases, a respondent may have never acquired the information to answer the question. Asking a man, which brand of sewing thread is most preferred by his wife would often fall into this category.

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

sking a respondent about a store or brand that they have never encountered creates the same problem. When a question is worded in this manner, it often pushes the respondent to give a wild guess. This cre

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

tes measurement error, since uninformed opinions are recorded and the data acquisition process renders false statistics.

(4) Consider the willingness of the respondent to answer the question: The memory of

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

Professional from academic institutions, pharmaceutical industries, health care indust

the respondent may be totally clear, yet the respondent may not be willing to give a truthful reply. Reporting of an event is likely to be distorted in a socially desirable direction. If the event is perc

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

eived as embarrassing, sensitive in nature, threatening, or divergent from one's self-image, it is likely either not to be reported at all or to be distorted in a desirable direction. One technique is to a

.

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

k the question in the third person. For example, "Do you think that most people charge more on their credit cards than they should? Why?" By asking about "most people" rather than about the respondents t

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

Companies that provide selfless information through particip

emselves, researchers may be able to learn more about the respondents' attitude about credit and debt. This data acquisition method makes embarrassing topics less intimidating for the respondent to discuss

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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