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E-Articles - Celebrating Traditions—or Why Hosting a Quinceanera is a Grand Thing
Several years ago, while we were living in Miami, our son, Nick, took part on the court of a Quincea?era party (a “Sweet Fifteen” for Latin girls) of a gal who was a friend, to be sure, although not necessarily a “best friend.” Never having encountered a “Quince” before, we had not the foggiest
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
idea of what was involved.
Turned out, this was ”the event.” Private dance lessons were on tap for everyone involved—everyone being the Quince princess, the seven fifteen-year-old girls on her court (think homecoming) and the accompanying seven fifteen-year-old boys. And not once, but twice,
Turned out, this was ”the event.” Private dance lessons were on tap for everyone involved—everyone being the Quince princess, the seven fifteen-year-old girls on her court (think homecoming) and the accompanying seven fifteen-year-old boys. And not once, but twice,
; 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
a private dance instructor gave them all private dance lessons so they would all dance perfectly when the appropriate time came (as in private dance instructor came to their house and gave private dance lessons for a couple hours each time…you do the math.) Girls wore floor-length gowns, coordi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nated to the white Cinderella-esque wedding style gown of the Quince girl; boys wore rented tuxedos. Nearly three hundred guests were invited to a sit-down dinner and professional photographers, cake makers, dance instructors, set designers, make-up artists and hair stylists all played their ow
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
distinct roles.
Now, my husband and I attended, invited as we were by virtue of the fact that our son was on the court. But our other children were not; they were simply told of the event after it occurred.
Fast forward five years. Our daughter vividly remembers every single detail of that Q
Now, my husband and I attended, invited as we were by virtue of the fact that our son was on the court. But our other children were not; they were simply told of the event after it occurred.
Fast forward five years. Our daughter vividly remembers every single detail of that Q
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
uince…lock, stock and barrel…and, now fifteen-years old, wants a complete and total re-enactment of the whole Cinderella bit.
Given that our pockets are not that deep, that we have no intention of doing the whole pumpkin-turns-into-a stagecoach thing on a revolving platform (no, I am not makin
Given that our pockets are not that deep, that we have no intention of doing the whole pumpkin-turns-into-a stagecoach thing on a revolving platform (no, I am not makin
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
g this up), we have told her that, yes, she may have a Quince and yes, it can even have a Cinderella theme (she is our only princess, after all) but that the line needs to be drawn in the proverbial sand by mom and dad with clearly-delineated markings.
Well, “clearly-delineated,” “pockets-not-
Well, “clearly-delineated,” “pockets-not-
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
that-deep,” and “Cinderelle-esque” are all relative concepts.
To live in Miami, which, let’s face it, has a clear majority of Latinos from all Spanish and Portuguese-speaking countries of the world, one embraces Quince parties because they occur each and every weekend in each and every year. T
To live in Miami, which, let’s face it, has a clear majority of Latinos from all Spanish and Portuguese-speaking countries of the world, one embraces Quince parties because they occur each and every weekend in each and every year. T
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
attend a Quince there at some point in your life is like, well, living in South America and celebrating “sweet fifteen” as a fact of life. Like breathing. To live in Fairfield County, Connecticut and host a Quince party is like living in the North Pole and hosting a luau. There ain’t none.
So
So
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
when our daughter announced that she was having a Quince, to all non-Spanish- taking high school freshman, they had no idea what in the world she was talking about. But to those who took Spanish in middle school, they had some inkling of the impending brouhaha. But as these girls had never liv
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ed in South America—or heck, even Miami—they truly had no clue.
OK. So she chooses her court. Seven girls. Seven guys. (Can you imagine what that was like?) We order the gown, and it is, indeed, a wedding gown. It’s very Cinderella-y. Billowy. Lots of tulle. We order the dresses for her court
OK. So she chooses her court. Seven girls. Seven guys. (Can you imagine what that was like?) We order the gown, and it is, indeed, a wedding gown. It’s very Cinderella-y. Billowy. Lots of tulle. We order the dresses for her court
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
(with the tearful note that her dearest friend from Miami who was to hold center court cannot make it up here for the event as she’s in the middle of exams. A sad late note for both girls.) We order the shoes (yes, they have a glass-like heel). We order the invitations. (An ordeal in and of it
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
elf. Have you noticed the cost of stationary lately?!?) Order the jewelry for each girl on the court. Ditto on the venue, the food, the DJ, and yes, if you can believe it, the dance instructors.
And then we start looking at tiaras. Now, I’m not Latin. (Nope. Pure-blooded Hungarian.) But even I
And then we start looking at tiaras. Now, I’m not Latin. (Nope. Pure-blooded Hungarian.) But even I
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
know that Quince girls wear tiaras. And they are like, very expensive. And I’m saying: “Cristina, can’t we just go to the mall and get you a cheap one at Claire’s?” You’d think I had committed heresy.
So we look at every friggin’ tiara on the display shelf at David’s bridal shop. They make th
So we look at every friggin’ tiara on the display shelf at David’s bridal shop. They make th
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
ese things from Swarovski crystal, you know! And I just had to draw the line. I mean, this thing was getting out of hand. So I start pacing back and forth and back and forth on the floor of the bridal shop, turning over and over in my mind what I’m teaching my daughter about money and budgets a
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
nd celebrations and indulgence and EVERYTHING is now all of a sudden riding on a stupid tiara.
She volunteers to pay for the difference between the one she really wants which is way out of my budget and the proposed one from Claire’s (which had an imaginary value anyway) and I coalesce and buy
She volunteers to pay for the difference between the one she really wants which is way out of my budget and the proposed one from Claire’s (which had an imaginary value anyway) and I coalesce and buy
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
her the tiara.
And when I talk to one of the court-gal’s mom the next day, we kibitz about these girls and teenage-hood and money and rites of passage. Having hosted two bat mitzvahs herself, she had perspective. And then she said what would hit me like a ton of bricks: “You’re not just having
And when I talk to one of the court-gal’s mom the next day, we kibitz about these girls and teenage-hood and money and rites of passage. Having hosted two bat mitzvahs herself, she had perspective. And then she said what would hit me like a ton of bricks: “You’re not just having
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
a Quince. You’re preserving a whole cultural tradition.”
And I stopped and thought about how these traditions come and stay. About how generations of children have celebrated religious heritages with bar/bat mitzvahs and christenings and baptism parties; about how American girls have Sweet Si
And I stopped and thought about how these traditions come and stay. About how generations of children have celebrated religious heritages with bar/bat mitzvahs and christenings and baptism parties; about how American girls have Sweet Si
.
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
xteen’s and how Latin girls have Quince’s. About weddings. And how these events occur just once in a lifetime. Once or twice in a family.
And I decided that making a big deal about a life event is a grand thing. That it thrills me to no end to have a daughter, and a precious, beautiful one at
And I decided that making a big deal about a life event is a grand thing. That it thrills me to no end to have a daughter, and a precious, beautiful one at
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
that. That few of us take enough time out to celebrate life. To enjoy laughter and fellowship and good food and good cake.
We’re getting ready to celebrate Thanksgiving next week here in America. Embrace it. And those you love. With good cheer.
For celebrations—Quincea?era’s--are grand things
We’re getting ready to celebrate Thanksgiving next week here in America. Embrace it. And those you love. With good cheer.
For celebrations—Quincea?era’s--are grand things
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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