Main Subject - Business

In order to standardize and make all medical records available to hospital staff, colleagues and officials many health care inst

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

itutions are computerizing their records and switching to an electronic medical records system. However, these

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

Examples of combination products may in

ystems are not universally accepted and the advantages and disadvantages are under debate by the medical community.

The idea be

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

ind electronic health records is to have a computer-based history of a patient's clinical and administrative details. This will

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

nclude every document made by each doctor that was ever involved with the patient's medical history.

The big benefit of this co

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

Combination pro

puterization is that it is easy for a new doctor to pull a patient's history, even from one hospital to another. On the flipside

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

is the ever-present possibility of invasion of privacy.

Different care providers in the medical community may have different pr

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

tocols in treating some conditions, and these differences may not be able to reflect in a shared medical record.

The issue with

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

all computerized systems is security. Software developers in the EMR industry are taking steps to improve security by adding fea

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

ures like username and password requirements. However, for the determined and experienced computer hacker, breaking a username a

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

d password combination is not too hard to do.

The newest security features to be added to computer systems are biometric identi

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

Following aspects would a

fiers. It almost sounds like science fiction, but it is becoming more and more common to use things like fingerprints, eye scans

dd to the challenges in developing combination products:

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

and voice prints in security systems.

The dream of the paperless work environment is a definite benefit of having an electronic

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

medical records system. Administrative staff are freed up from spending time managing files and having to make copies of records

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

and so on. The drawback is that now the doctors need some kind of portable device to access record when consulting with patients

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

A benefit of electronic systems is data accuracy. In a well designed software system, many data entry fields will be checked f

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

Professional from academic institutions, pharmaceutical industries, health care indust

r valid entries. With information being entered in a standardized way, the software can also be programmed to alert doctors abou

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

certain conditions for a patient, like allergies to drugs, drug interactions or medication errors. This kind of sophisticated s

.

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

ftware makes it possible for the pharmacy, doctor and nurse to interact in a whole new way.

The debate about electronic

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

Companies that provide selfless information through particip

medical record system may continue, but it is an almost inevitable fact of life for the future of the medical community

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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Rotation of the die and or air ring is used to bury errors built into the melt by process faults and which causes variations in the film thickness referred to as gauge bands.

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