Top Reference - Self Improvement

In the year 2000, I went on a mission trip to Guatemala with Wycliffe Bible Translators. It was a weeklong trip where we were able to see the results of the Bible translation work in Guatema

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

la. Before going, my friends were telling me I was going to become a missionary. I kept telling them, “No, I’m not. I’m just going to go on mission trips during the summers when school’s o

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

Examples of combination products may in

ut and I don’t have to teach.”

When I was in the beautiful country of Guatemala, I felt God impressing upon my heart the need for teachers in the mission field. Some families must leave the

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

mission field because their children aren’t receiving a quality education. I didn’t want someone to leave the important work of sharing the good news of the Gospel just because I was unwill

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

ing to teach in the mission field. I was worried about having plumbing and electricity like I have at home.

As part of the trip we stopped at a house where a missionary family was living.

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

Combination pro

It was a beautiful home very similar to what I might find in the United States. The only difference I could see was the water from the faucet wasn’t drinkable, but most people have bottled w

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

ater delivered to their homes. It was as if God was saying to me, “A little plumbing, Jill, that’s it! You think I can’t handle that?” I didn’t want to live without electricity either. Mos

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

t people also have electricity so that was also a question answered. I still didn’t want to go to a foreign country and live away from my family and friends and all that was familiar to me.

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

My second to last day in Guatemala, I prayed that if God wanted me to go into the foreign mission field, He would change the desires of my heart. Our final night there, we met as a group and

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

talked about our experiences. Almost everyone was changed as a result of the week. When I spoke, I started crying as I talked about how I believed God wanted me to teach missionary kids in

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

a foreign country. There were missionaries there who told me that teaching in the mission field would be better than teaching in the United States.

By the time I got back home, I wanted to

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

Following aspects would a

go teach in a foreign country. I ended up in Guatemala and actually have as students some of the kids that I met on that trip. A few weeks before leaving to come to Guatemala, I was nervous

dd to the challenges in developing combination products:

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

and thinking, “Should I just go to El Paso, Texas instead?” There was a mission there I could go to where I could go across the border to Mexico everyday and work there. I also had a frien

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

d in El Paso and could go home easily but decided against that since I would never know what might have been if I didn’t go to Guatemala.

When I got here, there were so many blessings God ha

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

d in store for me that I never even imagined or thought about. Right away, I stayed with two different families that reminded me so much of my own. They liked to play cards and board games

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 so did I. One of the families had kids the same ages as my nephew and nieces who liked to play outdoor games. My church family in Guatemala was a blessing to me also. They were so much

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

Professional from academic institutions, pharmaceutical industries, health care indust

like my church family at home and became my family in Guatemala. The climate was perfect, between 65 and 80 everyday of the year with very little humidity. There was fresh fruit and vegeta

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

bles available inexpensively and close to where I lived as well. I

used to worry a lot before coming to Guatemala but my first year here, I remember thinking, “God was preparing a place for

.

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

me in Guatemala before I even knew I was coming here and had taken care of every detail in advance. God is in control and knows exactly what He’s doing, so why worry?”

I love living in Gua

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

Companies that provide selfless information through particip

temala and teaching missionary kids and don’t have a plan to return and teach in the United States although I can go there during the summer and at Christmastime and see my family and friends

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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We all have choices in life and the choices we make determine how we live our live, how successful we are, and how happy we are. We all have a healthy inner voice that helps us make the best choices but most people have learned to tune this inner voice out and end up making bad choices in life.

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