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Traders and importers were relieved last Tuesday when the cost of petroleum had dropped below $64 per barrel. The fall came after the Iranian government h

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

ad made a softer and more positive response regarding its uranium enrichment project. The recent decision of the OPEC (Organization of Petroleum Exporting

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

Examples of combination products may in

Countries) to maintain the current output level also contributed to the decline of oil. Crude oil slid by $1.85 at $63.76 per barrel in the United States,

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

while it decreased by $1.56 to $62.99 in Britain. It must be noted that during the past months, traders and importers had been worried about supplies and

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

had felt the effects of the rising cost of petroleum. However, during the last two months, oil prices have dropped by around 20%.

The continuing fall of

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

Combination pro

prices have also raised questions among the OPEC members whether they should keep the current level of their production or reduce it. Earlier this week, t

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

e members of the global oil bloc had gathered in order to discuss current issues concerning the petroleum market. During their meeting, the OPEC members h

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

ad agreed to maintain their current target output despite the positive developments in the oil market. Needless to say, some members of the organization h

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

ve been concerned and have considered about reducing their production. While importers continue to benefit from the decline of prices, oil producing and e

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

xporting countries are becoming more anxious about the future of their business. In fact, Venezuela has called for the other members of the OPEC to monito

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

the oil market and to stop the prices of petroleum from dropping further. This was not the first time that the South American nation has urged the other

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

Following aspects would a

members of the global oil bloc to lower the production.

Oil experts said that the extent of the decrease of prices relied on the decision of the OPEC. Th

dd to the challenges in developing combination products:

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

organization, which has not yet disclosed the target oil price, decided last Monday to keep its output at 28 million barrels per day in order to ensure i

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

mporters of adequate supplies. If supplies from Iraq were included, the group's total output would reach up to 30 million barrels. However, Iraq is curren

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

ly excluded from the quota considering the oil issues its faces. The Middle East nation has long struggled to restore its oil business amidst terrorist th

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

reats and attacks to its facilities in the north. International Energy Agency Chief Claude Mandil commented that OPEC made the right decision considering

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

Professional from academic institutions, pharmaceutical industries, health care indust

he act that the prices of petroleum were still high. Meanwhile, US Secretary Condoleezza Rice stated last Monday that the United States might join in the

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

negotiations with the Iranian government if the latter agreed to temporarily halt its nuclear program. During the past months, the nuclear issue has rouse

.

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

fears among traders and importers that Iran might disrupt its exports if the tension intensified. But recently, the Middle East nation has offered a 2 mo

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

Companies that provide selfless information through particip

nth suspension of its nuclear plans thus easing the global oil market. Traders currently await on the results of the latest of the series of nuclear talks

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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