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E-Articles - You Can Go Home Again
Sometimes life hands you a wonderful gift. Going back to an era that you treasure is one. My college years are yellow with
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
time and age, but I remember them as being the best of my teens (I was an eager beaver and went from 16-20). Without a dou
; 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
t I had a blast.
Now don’t get me wrong. I was pretty much a square. After all, I was younger than all but one classmate
Now don’t get me wrong. I was pretty much a square. After all, I was younger than all but one classmate
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
there’s always one) and just because it’s my nature, I didn’t drink, smoke, take drugs or “sleep” with anyone. I really wa
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
(and am) a goody-two-shoes. This was the mid-70’s. I mention this mainly because I had three girlfriends who were pretty
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
much the same. I was a broadcast communications major with a dance minor. Two were dance majors and one joined us later a
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
a marketing student. She didn’t dance, except to exercise, but we all got along well. They wound up being my bridesmaids
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
After my marriage, we just somehow didn’t see each other. We lost complete track until about two years ago. One day I w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s sitting at the computer and thought “hmmm, I wonder….”
A few days later, one girlfriend, still stunned, wrote back! Thi
A few days later, one girlfriend, still stunned, wrote back! Thi
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
s rejuvenation of friendships has happened to me several times thanks to the internet. We started e-mailing back and forth
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
several times a month. Then last week-my husband and I met her for dinner! We had purchased season tickets to the theatre
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
where she just happens to work as the assistant to the director.
This dinner was truly a wonderful gift. Believe it or no
This dinner was truly a wonderful gift. Believe it or no
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
-we look pretty much the same. All three of us haven’t put on weight, we sound the same, and we knew who we were without 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
single bit of double takes “to be sure”. We sat down and pulled out some pictures to update each other on what our remain
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
ng family members look like now (we’ve both had some losses in a quarter of a century).
Then we talked and talked and talk
Then we talked and talked and talk
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
d. My husband even had fun. My girlfriend said she’s still in contact with the other two women and caught me up with thei
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
lives. She says they try to get together for birthday lunches. One’s married and has three adopted children. The other t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
wo have always led single and very full lives. Oh and me, married with two grown children. Somehow about to become a gran
.
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
ma.
Deciding this a complete success and a lot of fun-we are going to make these pre-theatre dinners a must. In fact, she
Deciding this a complete success and a lot of fun-we are going to make these pre-theatre dinners a must. In fact, she
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
s going to make a very un-birthday time call to our other bridesmaids and we going to try and make this into a real reunion
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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