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Advice Pool - Getting a Second Opinion
Can doctors be trusted? Some doctors know more about our bodies then we do. But doctors are not super humans! They make mistakes just as much as anyo
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
ne else so, it is best to get a second opinion. I should know I became a victim of being misdiagnosed but thanks to my wife, for being a medical assi
; 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
tant, we got a second opinion.
It all started when I began having abdominal pains. The pain I was experiencing was mild. It felt as if I was having
It all started when I began having abdominal pains. The pain I was experiencing was mild. It felt as if I was having
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
bad case of gas but was present every day. The reason I didn’t go see the doctor sooner is because I was getting use to the pain. I told my wife a f
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
w times of the pain but we both just brushed it off as a mild flu bug. It wasn’t until I had a few really bad attacks that we realized something wasn
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t right.
The first attack occurred at a wild game dinner. Every year I go to a wild game dinner at my father-in-laws church. They serve all kinds of
The first attack occurred at a wild game dinner. Every year I go to a wild game dinner at my father-in-laws church. They serve all kinds 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
meat and one of my favorites is the BBQ Coon. On one particular year I invited my dad to join me and two of his grandsons to a fabulous feast. I was
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
fine when we first arrived but after the dinner I began having severe abdominal pain. It felt as if I was coming down with a really bad case of the f
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
u. I told my dad we had to go because I was not feeling good. When I got home the pain had gotten so bad that I just went to bed. The next day I was
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
ine. For about two weeks I was having those mild pains I explained earlier. But again I brushed it off as being an after effect of the flu like symp
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
oms. At the end of the second week I asked my dad to come over and try my grilled fish. After eating the fish I had another attack. But it wasn’t unt
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
il the third week when I had another attack I decided it was time to see a doctor.
After sleeping my whole Friday away and not remembering a thing I
After sleeping my whole Friday away and not remembering a thing I
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
awoke on Saturday with the pain shifting to my right side. I explained to my wife I felt fine but she suggested I see a doctor because it may be my 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
pendix. Instead of going to my doctor I went to an after hours clinic. The doctor examined me and said I was having upper gastritis and urinary trac
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
infection. With disbelief my wife decided to get a second opinion. The second doctor listen to my story, took some blood work to be tested. When he
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
eturned he said my white blood cell count was normal but the story I gave made him question whether I was having an appendicitis attack. But he wante
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
d a second opinion so he sent me to the hospital to another doctor who specializes in appendicitis. After having more test done the doctor said I was
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
going into surgery immediately because I had appendicitis.
After the surgery the doctor told me my appendix had ruptured and was stuck to my abdomin
After the surgery the doctor told me my appendix had ruptured and was stuck to my abdomin
.
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
l wall which kept it from leaking. If I would’ve waited another day he would have had to open me up to clean my insides or I may have died.
Having a
Having a
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
second opinion doesn’t hurt even though you may trust your own doctor’s opinion. I had to see three doctors before I was diagnosed with appendicitis
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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