Main Subject - Business

Dear reader - this article was developed to explain in pray fully simple, basic words and with a universal understanding of why one COE does not fit all, why there are varied COE's, and the important question as to why different approaches are taken in administration. And why we have supported APEX since its inception in 1999.

Approaches: Please see th

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

e second section on the Gnostic and the Knights administration. Both require background reading and there is no substitute for gathering accurate and factual information. As we read the varied backgrounds, explore the historical significance, seek meaning for certain words, we begin to form the basis for our own beliefs, rather than blindly following or taking an oath wit

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

Examples of combination products may in

hout meaning.

Which ever approach is taken, an individual revisits a COE on a daily basis to instill the personal meaning and tempers understanding by application of honesty, respect, responsibility, fairness and compassion. This is not a one time trip. It is a continuous journey the whole of our lives on this earth.

One Does Not Fit All: Doctors, lawyers, web developers

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

, forums and all others have a very different set of objectives and as a result, have very different COE's, but again and again...all contain honesty, respect, responsibility, fairness and compassion. To me at least the highest COE among we mere mortals on earth is that of a mother, who also holds her warm arms around all, with she who is called "moral courage."

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

Conclusion: Ethics is an application which includes sound logic based upon more than casual inspection and must be a matter taken seriously today as in yester year. The survival our humankind depends upon order, not chaos, love not hate, compassion not ridicule and a quest to be stronger than a locomotive, run faster than a speeding bullet and being able to leap t

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

Combination pro

all buildings with a single bound.

Code of Ethics Background

Ethics is best understood by taking the individual's time for instruction, understanding and application.

Professional Associations are among those who adopt a "code of ethics" for their memberships. Each administers compliance with the code according to the specific needs and wants of the org

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

anization. But all include the core elements of honesty, respect, responsibility, fairness and compassion. Many also include the provision of "moral courage" which has an ancient origin.

The ancient origin of ethics has not been altered in any significant form from its beginning and continues today because the philosophy, is a study; not mere words in which one does not

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

seek understanding, truth and knowledge.

Origins of Ethics

Influenced by Daoism, Zhou Dunyi (1017-1073) commented on the Yi Jing (Book of Changes) and explained the cosmic diagram of the great ultimate in a new way according to Confucian philosophy that emphasizes ethics. Superior people cultivate moral qualities and enjoy good fortune, while the inferio

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

r violate them and suffer. Following The Center of Harmony (Zhong Yong), Zhou Dunyi believed the foundation of a sage comes from cheng, which means sincerity, honesty, integrity, and authenticity. From this integrity he derived the five traditional Confucian virtues of humanity, justice, propriety, wisdom, and faithfulness. Humanity is loving; justice is doing what is rig

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

ht; propriety is putting things in order; wisdom is penetrating; and faithfulness is abiding by one's commitments. Zhou Dunyi explained that in human nature are strength and weakness, good and evil, and the mean (center).

Confucius also concluded that music was central to this ordered universe in that the harmony was essential for its preservation and expansion. Reading b

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

ecame central to the application, but carried a divine responsibility, for having read one now has the duty to expand knowledge by administering to the needs and wants of those who could not read. Understanding and a one-ness became crucial to accomplishment of the end.

Administration of Ethics

An avenue of administration involves that of self or a Gnos

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

Following aspects would a

tic belief" where the individual seeks to rise to the level of angels so that each may" come that mystical level which brings the individual into direct" contact with the Divine. This administration includes three" attributes: incorruptibility, aspiration and surrender."

Without reciting the entire Code of Chivalry, which is a second administration of a code of ethics, we

dd to the challenges in developing combination products:

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

will mention a few. To call one's self a Knight and be afforded all of the rights and privileges an oath was sworn to uphold and included the following:

always champion right against wrong and good against evil.

be polite and attentive.

always keep your word

show courage in the face of the enemy

never be

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

cruel in battle and show mercy and compassion to the enemy.

Knights as a group administered their code of ethics. Those in violation where immediately stripped of knighthood. There was no tribunal summoned nor a vote of the membership. Three knights in good standing held the authority.

Historical footnote to the Knights administration: Augustinus the philo

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

sopher eluded to "three knights in good standing and their authority" but included the concept of "redemption" which allowed reinstatement. However after three "falls from grace" was given a permanent ban upon being a knight. Hence an origin of "three strikes and you are out."

Core moral values include honesty, respect, responsibility, fairness and compassion

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

and have come to be a kind of litmus test for ethical behavior. Added to that list is a word "courage" which is now commonly accepted but absent from formal presentations but abundant in classroom discussions and formal gatherings of those involved specifically in the area of ethics.

Courage comes in several forms: moral versus physical courage, where moral i

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

Professional from academic institutions, pharmaceutical industries, health care indust

s not about facing physical challenges that harm the body, but facing mental challenges that could harm one's reputation, emotional well-being, self-esteem or other. The first step in regaining high moral ground is to recognize moral courage which is like the string which ties a strand of pearls together and includes honesty, respect, responsibility, fairness, and

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

compassion. A second step is recognizing what "moral courage" is not: which is the exact opposite or in other words the easy wrong, rather than the hard right. Step three would be to engage in acts of moral courage, because with every experience lived, we can engage in the next without as much fear. The danger lies in refusing to face the fear, by not daring to c

.

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

ome to grips with it.

Conclusion

Codes of conduct, pledges of morality and other ethical charters have been with us from the beginning of time, yet there are humans who adopt lives by these codes knowing full well that others may not. That my good friends is the genesis of the APEX code of conduct which applies to our growing community. L

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

Companies that provide selfless information through particip

east we lose ourselves and our morality, please do not use the excuse that "others are not following" to do anything other ourselves than to lift each person up who honestly and compassionately tries to "live the code." And who may be found wanting, will witness the "moral courage" of a friend to bring each back into fellowship.

P.S. To err is human; to forgive is divine

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.mainsubjects.org.ua/article/18748/mainsubjects-Ethics--Or-Code-of-Ethics-COE-APEX.html">Ethics - Or Code of Ethics (COE), APEX</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/18748/mainsubjects-Ethics--Or-Code-of-Ethics-COE-APEX.html]Ethics - Or Code of Ethics (COE), APEX[/url]

Are you ending your online business strategies too soon? If so, you may be settling for the ability to sell a product instead of being recognized as an authority on your product. Find out why web branding can take your company to the next level.

We all make mistakes. That's how we learn. Consider these 10 Tips for Would-be Entrepreneurs:

Tags

Links

Main Subject - Ethics - Or Code of Ethics (COE), APEX

Related Articles: