Advice Pool - Health and Fitness

My father was an alcoholic who died at the age of 57. His drink of choice, at the time, was 100% over-proof rum.

I hated what alcohol did to him and what he did t

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

o our family while he was under the influence. When I was a teenager, I fell into the same trap and started to drink alcohol. Why? Because it was all I knew and

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

Examples of combination products may in

because of my family, I needed friends. It was easy to do what my friends did. I was headed down the same alcoholic path my grandfather and father were on. But fo

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

rtunately something happened which opened my eyes and made me want to stop my destruction. I had children! I realized that if I didn’t break the alcoholic chain, I

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

might give my children the same life I had and end up like my Dad.

I was already living his life style. I was going to the bars each weekend with my husband. It

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

Combination pro

ecame our weekend entertainment. We were having parties at our house with alcohol as the focal point.

Late one night, after another wasted night at the bar, while

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

my husband took the baby sitter home, I reflected on my life. I realized it wasn’t going anywhere. I knew if I didn’t make some changes, my kids would end up with

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

the same life I had as a kid.

It was then that I got down on my knees and asked God to help me to stop drinking alcohol. Fortunately, all I needed to do was make

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

the comment to stop, and I was able to do it. It was easy, I believe because I never got to like drinking and I never drank much. It had just become a social habi

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

t, which luckily I could easily break.

From that point, I have never tasted alcohol and my life has totally changed. In fact, to tell you the truth, my life is so

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

wonderful today that I would rather die than ever again taste an alcoholic beverage.

How blessed I am that my kids did not end up with the life I had as a child,

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

Following aspects would a

and I didn’t end up with the life my dad and grandfather ended up with.

How thankful I am to have started a new healthy life cycle for my childlren to follow. My

dd to the challenges in developing combination products:

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

children are well-adjust adults who are successful and don’t drink. They teach my grandchildren to follow the new path I have established.

I am still married to

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

my husband of 47 years. We have an alcohol free, happy life together. How did I change my life? I found truth and lived it. I discovered alcohol is a robber of a

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

ll the good things of life. It makes you think you are having fun when in reality you are just wasting your life away.

When I said that prayer, so many years ago

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

nd asked God to help me, my prayer was answered and my whole life changed in marvelous new ways, for the better.

What were the steps, which helped me, have a new

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

Professional from academic institutions, pharmaceutical industries, health care indust

life?
1. I found God and asked Him to Help me change my life.
2. I repented.
3. I quit drinking and made a commitment to never drink again
3. I

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

tried to make up for my mistakes and I learned to be honest
4. I was obedient to God’s commandments
5. I learned how to love
6. I discovered and de

.

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

veloped my talents and gifts
7.I worked toward my potential to serve others and do good things with my life.

I have a happy life and I pray that you will to

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

Companies that provide selfless information through particip

o.

I pray that you too will discover the truth of alcohol and choose to never allow it to be a part of your life! I pray you will be a good example to your family

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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