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With the evolution and development of appraisal systems, a number of tools and techniques of performa

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

nce appraisal have been developed. Firstly, there are graphic-rating scales which compare individual

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

Examples of combination products may in

performance to an absolute standard. In this method, judgments about performance are recorded on a sc

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

ale. This is the oldest and most widely used technique. This method is also known as linear rating sc

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

ale. The appraisers are supplied with printed forms, one for each employee. These forms contain a num

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

Combination pro

ber of objectives and behavior- and trait-based qualities to be rated (like quality, volume of work,

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

job knowledge, dependability, initiative and attitude). Rating scales are of two types: continuous ra

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

ting scales and discontinuous rating scales.

In continuous order like 0, 1, 2, 3, 4 and 5, the appra

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

iser assigns the points to each degree. Performance regarding each character is known by the points g

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

iven by the rater. These points are added up to find out the overall performance. Employees are ranke

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

d on the basis of total points assigned to each one of them. One reason for the popularity of the ra

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

Following aspects would a

ting scale is its simplicity, which permits many employees to be quickly evaluated. Such scales have

dd to the challenges in developing combination products:

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

relatively low design cost and high incase of administration. They can easily pinpoint significant di

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

mensions of the job. The major drawback of these scales is their subjectivity and low reliability. An

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

other limitation is that the descriptive words often used in such scales may have different meanings

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

to different raters.

Another popular and effective method of performance appraisal is employee ranki

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng. Under this method the employees are ranked from best to worst on some characteristics. The rater

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

first finds the employee with the highest performance and the employee with the lowest performance in

.

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

that particular job category and rates the former as the best and the latter as poorest. Then the ra

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

Companies that provide selfless information through particip

ter selects the next highest and next lowest and so on until he rates all the employees in that group

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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