Social Space - Food and Drink

Never, ever, ever turn a young twit loose in a kitchen who claims she knows how to make a cheesecake, especially never when company is expected, p

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

articularly if that company is a VIP-such as the boss who is responsible for the roof over your head.

La Twit convinced me that she had made perf

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

Examples of combination products may in

ct cheesecakes in Home Economics class and at Suzy Q's sleepover parties. So I capitulated to her sales pitch, a stream of positive statements not

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

counting thoughts separated by ah, um, the "like" word, and her megawatt smile. In a word, I was bedazzled.

First she went shopping, not for chee

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

secake ingredients, but for the perfect apron that would protect her eclectic fashion statement while simultaneously adding pizzazz to the layered

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

Combination pro

look. The chosen apron was a flirtatious accessory, almost as saucy as the stereotypical French maid's long-handled feather duster. La Twit donned

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

the apron over an artistically-and expensively-torn tie dyed T-shirt that fluttered above her pierced navel. Riding on her hips was an extra layer

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

of epidermis known as jeans. When it came to her attire, La Twit's apron garnish proved she had the capacity to plan ahead-that is if her plan wa

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

to become La Twit de la soir.

Compared to her exotic costume, the ingredients for the cheesecake were mundane. Graham crackers, sugar, butter, e

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

gs, cream, cottage cheese, flour, lemon, walnuts. La Twit followed the recipe, precisely. Well, she cheated a little. For example, she melted more

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

butter than the recipe called for but she grated half as much lemon rind as listed and went nuts chopping extra walnuts. These were not serious in

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

Following aspects would a

fractions and so could not be responsible for the disaster that emerged from the oven-a semi-firm pudding. Did La Twit panic? Ask me if I did.

"Y

dd to the challenges in developing combination products:

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

u told me you knew how to make cheesecake!"

She smiled. La Twit had the audacity to flash that megawatt smile. "Lawdy, Miz Scarlet, ahs don't kno

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

s nuthin' ‘bout makin' cheesecake!" Before I could react, she winked and reached into the cupboard.

She placed eight stemmed desert dishes on the

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

counter. She sliced through the would-be cheesecake into the graham cracker crust and ladled each would-be wedge into a dessert dish where the cr

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

st broke apart and the cheesecakey pudding found its own level. She grabbed a can of chocolate syrup and drizzled it over the you-know-what. Then

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

Professional from academic institutions, pharmaceutical industries, health care indust

he reached into the refrigerator for a can of real whipped cream, squirted it generously over the chocolate rivulets, and topped it all off with e

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

nough chopped walnuts to choke a horse.

Everyone loved the dessert. Everyone wanted to know what it was. I looked across the table to the would-b

.

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

pastry cook, demure and gorgeous in a silky turtleneck and long skirt, eager to hear how she would answer. "Prissy's Pudding," my eldest niece re

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

Companies that provide selfless information through particip

ponded smoothly, every pore a-sizzle with sweet sophistication. But I knew that after a good night's sleep, La Twit would re-emerge in the morning

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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