Advice Pool - Relationships

Paul and Karla came to know each other on ChristianCafe.com February 6, 2006 when Paul saw "blondie" and wrote her. Initially Karla thought after reading Paul's self-descriptive profile (w

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

herein were his accomplishments and goals) that he might be a bit too intense for her. Paul wrote back happily saying that he understood and wished Karla well considering there are 3 billi

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

Examples of combination products may in

on men on the planet.

To Paul's surprise Karla wrote back again the next day saying that after she saw Paul's websites, particularly his ministry site, she couldn't quite escape him. She

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

felt compelled for some reason to write Paul again. Thus began their correspondence which built their friendship. Paul took such an interest in Karla that he even wrote her lengthy daily e

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

mails and she him from Canada, while Paul was aboard a cruise with his mom, dad and brother in March. Emails from the cruise ship in the Carribean ranged between $10 to $20 a day, yet Paul

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

Combination pro

thought writing Karla was a good investment.

By March Karla thought it was about time for the two to meet to see if there was any chemistry in person. Karla then, against the warnings of

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

some cautious and concerned friends (but with the support of her father), went to Florida to meet Paul.

Paul and Karla had a wonderful time in Florida visiting the beach, various attract

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

ions and getting to know one another. While together, no matter what they were doing, or where they were, they always had a blast together. They both like to laugh, clown around and joyous

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

ly do so whether at a water park, at the local store or in the car. Incidentally the "chemistry test" went very well.

In late April and early May, Paul was scheduled to minister in Hollan

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

d and attend a conference in Paris, France. Since Karla is half Dutch and has always wanted to visit her homeland, Paul didn't hesitate to invite her along. Thankfully Karla was able to ge

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

time off work and accompany Paul. It proved to be a fabulous Europe trip and Karla's first.

They celebrated Queen's Day in Holland, saw all the sites in Paris, visited the Mediterranean

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

Following aspects would a

and even got a tour of the Monte Carlo Casino in Monaco. It was a most magical experience and one never to be forgotten. Before taking Karla to the Charles de Gaulle airport in Paris on Ma

dd to the challenges in developing combination products:

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

y 7th, when she was to leave, Paul took her by the Eiffel Tower and asked her to marry him.

On Paul’s way back from France after the conference, he “just happened” to have his plane route

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

d through Toronto and took a couple days in Canada to see Karla. It was good for Paul to see Karla in her element, discover she is a Martha Stewart type - neat and very organized (very rea

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

ssuring for him a creative type who is administratively challenged at times).

By now Karla and Paul had been to 5 countries together. Considering Paul’s jet setter lifestyle, Karla pretty

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

much knew becoming a globe trotter was her destiny with him. Paul had to twist her rubber arm a bit to get her to agree to such a lifestyle, but did warn her about the occasional fleshly

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

Professional from academic institutions, pharmaceutical industries, health care indust

discomforts and light afflictions of going abroad to minister. Karla did not flinch and remained steadfast in her zeal and determination to marry Paul fully committing to be with him wher

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

ever he may go.

Paul and Karla are still busy planning their big day, excited and eager to get married September 3, 2006. Karla will be moving to Florida after their honeymoon in Fiji and

.

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

Australia where they plan to get further connected and enjoy some scuba diving. Once under the same roof, Paul and Karla will write books and travel the world together ministering to huma

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

Companies that provide selfless information through particip

nity.They will also focus on Life Coaching and finding their dream beach house together where they can surf and stroll along the beach hand-in-hand...any support is greatly appreciated! :-

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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If we use technologies such as virtual reality, video conferencing and tele-commuting we can perhaps reduce pollution. By how much you ask? Well that is hard to say, what we need is some brilliant crack researchers to come along and figure out just how much we might save and how much pollution we might prevent by leveraging these high-tech methods.

Surely someone other than John Ralston Saul (Kings College Doctor of Economics) has noticed the fact that these things are even more important than the wars of the 20th Century but I have found few people really care as long as they continue to believe what the media shills feed them for their nightly news.

The contemplation of suicide demonstrates the necessity of hope! While the circumstances surrounding suicide are varied, many turn to suicide because of a loss of hope. He or she has decided that life's not worth living. This tells us in order to live we need hope that will sustain us through life's painful circumstances. Where do we find the kind of hope that will anchor us when our little boat has capsized on the sea of life?

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Advice Pool - Paul and Karla: Match Made in Heaven

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