E-Articles - Health and Fitness

It has now been shown that men that take pain relievers on a regular basis may have an increased ris

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

k of high blood pressure. Researchers in the United States have shown that certain pain killers, in

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

Examples of combination products may in

particular, acetaminophen, ibuprofen, and ASA might be susceptible to high blood pressure.

These t

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

ablets are given frequently and can be purchased across the counter without a doctor’s prescription.

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

They all can be taken for aches and pains, headaches and coughs and colds. Previous studies have

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

Combination pro

shown that these medications can increase the risk of high blood pressure in women, but now the link

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

to men has been suggested.

The study from Harvard Medical School in Boston showed that out of 16,0

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

00 male health professionals, the risk of high blood pressure was greater when those particular pain

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

killers were taken. There are health implications because blood pressure has significant issues fo

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

r men and women if uncontrolled. Even when diagnosed, it has been shown that high blood pressure ha

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

s an adverse affect on mortality and morbidity.

Because the pain killers are given on a frequent ba

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

Following aspects would a

sis and can be purchased without prescription, it is important that the health effects of these are

dd to the challenges in developing combination products:

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

known and communicated to the general public. One of the pain killers, acetaminophen, cause blood p

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

ressure to rise in 34% of men when they were taking the drug on a regular basis. For aspirin, the r

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

isk was 26%, and for ibuprofen 38%. Basically, these drugs can block the affects of chemicals that

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

cause blood vessels to relax. Relaxing blood vessels decreases blood pressure; therefore these medi

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

Professional from academic institutions, pharmaceutical industries, health care indust

cations cause higher blood pressure through the reverse of this process.

The problem is complicated

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

by the fact that men who have heart problems are advised to take aspirin for this. The general adv

.

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

ice is that aspirin should be continued to be taken in this situation. The best way to avoid blood

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

Companies that provide selfless information through particip

pressure is to continue with physical activity and physical fitness, lose weight, and reduce stress.

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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