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Delicious - My Name is HAD-- Life Lessons Learned!
My name is Had. You may know me, but you may not know my new name. You may have no idea what I ‘ve been through because I do my best to look the same. I am scare
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
d to death of you. I use to be just like you. I once held my head up high without propping in on my hymnal. I was well respected back then, and I even respecte
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
d myself. I was whole-hearted devoted to God, and if the truth be known, somewhere deep inside I was sometimes the slightest bit proud of my devotion. Then I’d
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
repent because I knew pride was wrong. I didn’t want to be wrong. Not ever. People looked up to me. And life looked good from up there. I felt good about who 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
was. That was before I was Had. Strangely, I no longer remember my old name. I just remembered I liked it. I liked who I was. I wish I could go back. I wish I
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
would just wake up. But I fear I’m wide awake. I have had a nightmare. And the nightmare was me Had.
If I could really talk to you and you could really listen
If I could really talk to you and you could really listen
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
, I‘d tell you I have no idea how all of this happened. Honestly, I was just like you. I didn’t plan to be Had. I didn’t want to be Had. One day I hadn’t, and th
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
en the next day I had. Oh, I know where I went wrong. I have rewound the nightmare a thousand times, stopping it right at the point where I departed the trail
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
f good sense. The way ahead didn’t look wrong. It just looked different. Strange, he didn’t look like the devil in the original scene. But every time I replaye
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 it, he dropped another piece of his masquerade. When he finally took off his mask, he was laughing at me. Nothing seems funny anymore. I will never laugh agai
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
as long as he is laughing.
If only I could go back. I would see it this time! I would walk around the trap camouflaged by the bush, and I would not be Had. I
If only I could go back. I would see it this time! I would walk around the trap camouflaged by the bush, and I would not be Had. I
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
would be proud. Was that my old name? Proud? I can’t even remember who I was anymore. I thought I was Good. Not Proud. But I don’t know anymore. Would you
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
believe I never heard the trap shut? Too many voices were shouting in my head. I just new I got stuck somewhere unfamiliar and soon I didn’t like the scenery a
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ymore. I wanted to go home. I pulled and pulled on the trap but the foothold wouldn’t budge. I had no way out. I screamed for God. He came for me. As he ins
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
pected my shattered ankle I expected him to say, “You deserve this, you know. You’ve been Had.” Because he did and I know and I have. He hasn’t said it yet. I
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
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
don’t know how much to trust him yet. I’ve never known him from this side. My leg still hurts. God says it will heal in time. But I fear I will always walk with
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
a limp. You see I wrestled with the devil and he gave me a new name. Had.
Have you ever been Had? God says He doesn’t want us to forget. We say, we just want t
Have you ever been Had? God says He doesn’t want us to forget. We say, we just want t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
o be healed. Has Good or Proud ever gotten in the way of you being Healed? There have been more Hads than Good or Proud may ever know. And sometimes it takes a H
.
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
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
s Been to know a Had. God wanted to make sure we never act like we never been Had, so he leaves the scares. Never forget where you have been, and never forget t
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
he dead times God has raised you up from the times of being Had. Learn from them, mature from them and praise God for the Had that you once were and may be again
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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