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(Note: This is a true story but the names have been changed to protect the innocent.)

Recently, my twenty five year old friend Jenna Fromstein had a small superficial mole on her left buttock. I told her it was nothing but her doctor, Doctor

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

Garbowicz decided that he had to operate in order to remove it and biopsy it in case it was skin cancer. Jenna went in for the surgery under general anesthetic. A week later Jenna noticed that the mole was still there. So she goes back to Dr.

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

Examples of combination products may in

arbowicz and shows him that he missed the mole by 6 inches. Dr. Garbowicz tells Jenna that he has to operate again. All Dr. Garbowicz really had to do was in his office take a small scraping from the small superficial mole and have it tested f

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

r cancer cells. If it was benign then he could leave it alone.

Jenna then went in for her second surgery. This time Dr. Garbowicz cuts Jenna right down to her pelvic bone. Two months of Hell later the wound still hadn’t closed. They couldn’t

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

titch it because the wound was too wide and the oozing puss would have been trapped. For two months Jenna had daily nurses’ visits. Jenna’s medical expenses were already astronomical. Then the wound became infected. The antibiotics didn’t work

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

Combination pro

and gangrene set into both of her legs which Dr. Garbowicz had to amputate. Jenna is now in intensive care fighting for her life. The question is “Why did Jenna stay with Dr. Garbowicz after the first botched surgery?” That decision backfired

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

ompletely.

President Bush vowed today to prevent Al Qaeda from setting up a violent radical Empire in Iraq, which he said was Osama bin Laden's ultimate goal. Who made this goal possible? Prior to President Bush invading Iraq 3? years ago, 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

sident Saddam Hussein made sure that not one single Al Qaeda member set foot in Iraq, and Saddam Hussein held Iran tightly in check. Why did the American people stay with President Bush after his first term in office?

There is a joke. What is

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

the difference between God and a Doctor? A. God doesn’t think that he’s a doctor. Before the American people re elected the butcher of Washington, the BBC reported that in an interview with two BBC reporters George W. Bush said that God told h

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

m to invade Iraq. Which God? Jesus Christ preached Pacifism. He said in the Sermon on the Mount that the Bible was wrong, an eye for an eye was wrong. Jesus said that if someone punched you in the right cheek, turn your head and let him punch

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

ou in the left cheek also, like Nicole Brown Simpson. Jesus said, “Don’t hit back even in self defense.” Not that Jesus knew Nicole Brown Simpson but he did die for her sins two thousand years before she was born.

Jesus was a Jewish Rabbi who

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

Following aspects would a

lived 2,000 years ago. Jesus created the Universe 15 billion years ago. He couldn’t fight off a few Romans in rooster hats but he created the Universe and everything in it. Jesus did not die for the sins of Ronald Goldman or Doctor Garbowicz b

dd to the challenges in developing combination products:

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

cause they were both Jewish. The Old Testament of Judaism has now metastasized into becoming the Holy Scripture of Christianity and Islam too, and these 3 religions are now leading us all against each other into nuclear world war 3, the extinc

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

ion of life on Earth forever. Why did we all stick with these religions? This decision will be the final backfire unless we all switch to The World Peace Religion right now.

The chances of this happening are slim and nil. On a planet where bi

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

lions of people are following the Old Testament, Psalm 2, in which God of Mount Sinai (aka Jesus Christ, God the Father, The Holy Spirit, Allah (God of Mount Sinai in Arabic), Adonai (God of Mount Sinai in Hebrew)) promises that he will send H

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

s Messiah with a rod of iron to smash every man, woman and child outside of your group like a potter’s vessel into a million pieces, the people are not interested in peace. They can’t wait for Katie Couric to report that miraculously Jesus Chr

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

Professional from academic institutions, pharmaceutical industries, health care indust

st has appeared in Jerusalem and conquered the world for your religion.

The problem is that the Old Testament was written in Hebrew. It promises that the Messiah will smash all non Jews. When the Christians adopted it they changed the words “

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

on Jews” to “non Christians”. When the Muslims adopted it they changed the words to “non Muslims”. But lets not get bogged down in technicalities. The main thing to remember is that Elvis is still in the building, Suri Cruise is alive and well

.

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

and gracing the cover of Vanity Fair magazine and it’s all just a dream Jenna. Your daddy isn’t the anti Christ. 1 billion Muslims are wrong. It’s a case of mistaken identity. It was really Mother Hubbard aka Cardinal Wolsey who pulled the rug

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

Companies that provide selfless information through particip

out from beneath the feet of King Henry VIII by Herman’s Hermits. She wouldn’t have a Willy or a Sam, no Sam! She married 8 Henrys. O Henry, baby. Yes, Yes, No, No, Don’t Stop! Harder! Faster! Yes, yes, Yes!! The poor little doggie had no bone

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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