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When working either in a clinic or in a lab, one instrument that is used very commonly to carry liquid is called a

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

pipette. This is a bigger version of the medicine dropper and works on the same principle of creating a vacuum 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

o draw up the liquid, which is released when this is pressed.

In order to ensure accuracy at all times, this inst

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

ument needs to be calibrated. This depends on four important factors namely; the skill of the people working in th

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

e lab as well as the handling of such equipment, the type of liquid that is being placed into the pipette and the

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

Combination pro

ype of work where this instrument is used.

In most cases, these instruments are calibrated every 6 months but com

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

panies that are engaged in with food or drugs are required to this quarterly or every 3 months. Schools that condu

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

ct chemistry classes can do this annually but those involved in research and forensics where a lot of testing goes

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

on will have to do this monthly.

How are pipettes calibrated? This is usually done through gravimetric analysis.

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

Each instrument undergoes testing by dispensing distilled water into a vessel. Each pipette should be able to rele

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

se the same volume to get the required weight as set by the National Institute of Safety and Standard or NIST.

A

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

Following aspects would a

more expensive way to calibrate the pipettes is by the colormetric method where colored water is used and dispense

dd to the challenges in developing combination products:

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

d. A spectrophotometer is used to measure the weight, which can later on determine if some adjustments in the inst

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

uments have to be made.

The type of calibration to be done will really depend on the contractor chosen. The most

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

rigid which certifies that the place is up to international standard is when it is ISO/IEC 17025, which is the hig

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

est so far.

This means the personnel in the facility are well trained and practice the most advanced techniques w

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

Professional from academic institutions, pharmaceutical industries, health care indust

hen conducting anything in the lab. It is not only private companies that do this but also other places that are r

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

un by the government such as the Center for Disease Control or CDC and those run by law enforcement agencies. This

.

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

to ensure the safety of the employees and the people.

So, if the person needs to do blood work or any other test,

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

Companies that provide selfless information through particip

it will be a good idea to do it in a place that has these standards in place to get unbiased and accurate results

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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