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I often ask myself this question. Not in the times of prosperity or when everything is going great. But, in the times when I feel alone or everything seems to be stagnant. There has been this lurking question underneath all the good times and all the bad times. When

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

life is going great, I sense that this is what life is all about. In the bad times, I have to wonder if this is what life is supposed to be.

I believe that many of us have asked this question. Some of you have searched and others have not and just gave up. I used to

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

Examples of combination products may in

be one that searched. I thought maybe if I can get through school and get a particular job or date this person, maybe get married or have some children: then this would answer the question. The problem was that I kept coming up short and wasn’t convinced that this w

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

as all life had to offer. The cycle went something like this…I had an idea then I would try it…it would give temporary happiness then I would end up disappointed, frustrated, alone and then some time later I would start back at square one.

Still there was this naggi

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

ng in my soul. I often tried to shut it up by drowning it out with loud music, alcohol and partying. Or I would continue to keep myself busy with work so that I wouldn’t have to deal with “it”. It worked for a while, but it would still come and “pester” me. I went th

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

Combination pro

ough some counseling and thought that I needed to deal with some of the painful events of my past: which I did and it was extremely helpful. But there it was, never satisfied, always coming back.

I was convinced that there was nothing on this earth that was going to

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

satisfy this longing, so I broke down and began to pray. The next few weeks changed my life forever. Believe me, I never imagined that I would be writing about this or even writing at all. I met a man. Not just any man but someone who promised to never leave me. He

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

told me that when I committed myself to him at the age of 14 that he was in it for life. He told me that I forgot about him but that he never forgot about me. He said that I didn’t have to go through this life alone. I told him that it sure felt like I was alone. I t

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

old him that I was pretty angry with him for not stopping some really bad things from happening to me. He began to cry and said that he understood because he had been through some really bad things himself. Well that wasn’t good enough for me…I wanted some answers.

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

I wanted to know “why”?

He said, “I love you and I want you to come back home”. I told him that I couldn’t because I was ashamed and really confused. I didn’t understand how he could still love me after all I had done. I told him that I was scared of him because I

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

hought he was going to punish me. He kept on saying, “I love you so much, I want you to come back to me, I don’t care about where you’ve been I just want to be your friend and love you like no other.” Finally, it hit me. He was right: he never left me. It was me who

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

Following aspects would a

left in search for purpose, for excitement. I forgot that I had met him so many years ago. He told me that he would never let me go. Then, the “nagging” stopped. I looked up and saw the King with his outstretched hands saying, “come home, my child, it’s been way too

dd to the challenges in developing combination products:

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

long”. I ran into His arms and will never be the same.

There is a parable in the Bible that depicts a man with two sons. One day one of the sons went to his father and asked for his share in his inheritance. The father gave his son what he had asked for. The boy lef

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

t and squandered all that he was given in foolish living. After his money was spent, he realized that he had nothing, not even food to eat. He decided that he would return home to his father, confess his sins and ask to become a servant. While he was on his journey h

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

ome, his father saw his son and had compassion on him. The Bible says that his father ran to him and embraced him. The son quickly confessed his sins and told him that he would no longer be a son, but a servant. The father looked at his servants and said, “Hurry! Bri

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

g the best clothes and put them on him. Also, put a ring on his finger and sandals on his feet. And get our fat calf and kill it so we can have a feast and celebrate. My son was dead, but now he is alive again! He was lost, but now is found. So they began to celebrat

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

Professional from academic institutions, pharmaceutical industries, health care indust

e.” (Luke 15:22-24 NCV)

God is so good and gracious to us. He loves you so much and there is nothing that you can do that would separate you from his love. God’s grace is truly amazing and his touch will send your spirit soaring. I don’t know how to put in to words

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

how much he cares for you and longs to wrap his loving arms around all the pain and mistakes in your life. He tells us to come as you are. If you’re dirty, he will give a bath in his amazing grace. If you’re ashamed, he will give you honor. If you’re broken, he will

.

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

restore you. If you are confused, he will give you peace.

All He wants is you. Will you call to him today? Just wanted to tell you that if you’ve ever had that longing deep in your soul: that there’s got to be more to this life, rejoice! The King is requesting your

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

Companies that provide selfless information through particip

presence. This is one appointment that you don’t want to miss.

If you would like to find out more about God and the gift that he has to offer you, I urge you to contact me through my e-mail and I would love to share this with you. May God bless you. keisal1@yahoo.co

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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