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Had Pope Benedict XVI omitted the citation of Emperor Manuel II Paleologus' remarks about the Prophet Muhammad bringing only what is "evil and inhuman" to the world, a quote he himself admits was marginal to his argument, he would not have emphasized as clearly as he

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

has done the focus of his central argument - that is modern secular rationalism needs to heed the contribution of faith to enable it to break out of the narrow confines of absolutism and fundamentalism. Which is specifically the problem with Islam, both as a religious doctrine and as a ‘way of life'.

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

Examples of combination products may in

To understand this point, Non-Muslims must focus on the difference between Islam and Islamism. Islamism is a set of political ideologies that holds that Islam is not only a religion, but also a political system that governs the legal, economic and social imperatives of the state according to i

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

ts interpretation of Islamic Law. For Islamists, the sharia has absolute priority over democracy and universal human rights. The terms "Islamist" and "Islamism" are used often in several publications within some Muslim countries to describe domestic and trans-national organizations seeking to

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

implement Islamic Law.

There is intense debate in the Muslim world about the differences between Islam and Islamism. The controversy is rooted in differing answers to questions about how Muslims should live, the sort of governments they should support, and the proper role of Islamic symbols, ideas,

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

Combination pro

and tenets in the modern world. Those who are called Islamists argue that Islam is inherently a political religion, and that the rules and laws laid out in the Al Qu'ran and Hadiths mandate Islamic governments.

In its bare essence, the substance of Pope Benedict XVI's argument can be summed up

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

in the following syllogism: Islam is faith devoid of reason; modern secularism is reason devoid of faith; Christianity is a dynamic wedding of faith to reason. Both faith without reason and reason without faith can be very destructive. Ergo, both Islam and modern secularism should learn from Christia

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

nity the art of the mutual enrichment between faith and reason. Which, admittedly, sounds overall a little bit one-sided.

That said, however, the phenomenal overreaction of Muslim leaders and masses around the world to the Pope's remarks proves once again that Muslims do indeed have a problem with ra

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

tionality. It is not by rioting on the streets and calling for jihad and the destruction of the Holy See and, in fact, of all symbols of Christianity and Judaism that Muslims can hope to re-build their tarnished image as well as the proper civil institutions, which could have both the capabil

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

ity and authority to respond effectively and in a measured way to the challenges facing them today.

Exaggerated reactions such as those to the Pope's speech or the ones involving the publication in the Danish newspaper Jyllands Posten some time ago of cartoons depicting and satirizing the Pr

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

ophet Mohammed reflect the general inadequacy of the Islamic State and civil organisations, which lack both the authority and the effectiveness in dealing with the perceived challenges. They also reflect the deep ignorance of the Islamic masses and their aversion to anything and everything which they

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

Following aspects would a

characterize as non-Islamic.

The failures of Islam, as correctly pointed out by the Pope, are multi-faceted and stand in the fact that Islam - both as a religion and as a way of life - has failed to achieve many of its goals. Raising standards of living, ridding societies of corruption (corruption in

dd to the challenges in developing combination products:

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

all its manifestations, incidentally, is expressly forbidden by the Prophet), freeing people from chronic, centennial poverty, failure to allow freedom of thought and expression even in their basic forms and even protecting Islam from what Muslim scholars have dubbed a ‘rampant Westernization'.

It i

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

s not through its inveterate Western-phobia, anti-Americanism and utter dislike of Israel that Islam will ever solve its own shortcomings. But, above all, it is through the embracing and acceptance of jihad or holy war as a means to spread the faith that Islam manifests its own irrationality

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

in its entirety. And this is specifically what the Pope was referring to when he cited Emperor Manuel II Paleologus' remarks, which were rendered within the wider context of the subject of Christianity and Islam, and the truth of both faiths.

The message of the Pope was that faith is born of the soul

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

, not the body. Whoever would lead someone to faith needs the ability to speak well and to reason properly, without violence and threats. To convince a reasonable soul, one does not need a strong arm, or weapons of any kind, or any other means of threatening a person with death.

Contrast this message

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

Professional from academic institutions, pharmaceutical industries, health care indust

with the teachings of the Prophet Muhammad in the matter of spreading Islamic faith to the rejecters of truth (infidels) after truth has become evident to them:

"Kill them wherever you find them and drive them out [of the place] from which they drove you out and [remember] persecution is worse t

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

han carnage. But do not initiate war with them near the Holy Kabah unless they attack you there. But if they attack you, put them to the sword [without any hesitation]. Thus shall such disbelievers be rewarded. However, if they desist [from this disbelief], Allah is Forgiving and Merciful. Keep fighti

.

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

ng against them, until persecution does not remain and [in the land of Arabia] Allah's religion reigns supreme. But if they mend their ways, then [you should know that] an offensive is only allowed against the evildoers. A sacred month for a sacred month; [similarly] other sacred things too are subjec

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

Companies that provide selfless information through particip

t to retaliation. So if any one transgresses against you, you should also pay back in equal coins. Have fear of Allah and [keep in mind that] Allah is with those who remain within the bounds [stipulated by religion]." (Qu'ran, 2:190-194)

Quite a mouthful!

Luigi Frascati

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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