Advice Pool - Business

“And what would you like to drink?” the perky server asks.

“I’ll have a Diet Coke, no ice, and a slice of lime, please.”

A

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

bout five minutes later, our drinks arrive.

Mine has ice, and there’s no lime.

I may as well take a sip anyway; I’m parche

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

Examples of combination products may in

d.

Hey, that’s too sweet to be a Diet Coke. I’ll bet she gave me the regular brew.

It’s amazing that a restaurant’s server

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

can make three errors when handling a simple soft drink order, but it happens to me all the time.

Before you blame me for

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

my misfortunes, thinking I mumble or something, I must tell you I’ve tried everything to help servers to get it right, from

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

Combination pro

speaking S-L-O-W-L-Y to repeating the phrase before they scurry away:

“Again, that’s a Diet Coke, no ice, and a slice of li

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

me, please.”

Still, more than 50% of the time I get either ice or a bright yellow LEMON, instead of the lime.

I’ll even re

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

sort to redundancy: “I’ll have a Diet Coke, no ice, and a slice of GREEN lime, please.”

Once, a savvy waiter caught this an

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

d replied: “I thought limes only come in green!”

Then, I regaled him with the back story about how often his colleagues get

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

it wrong, thinking lemons and limes are interchangeable. He smiled and nodded, knowingly.

What are the results of these er

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

rors?

(1) I send back the defective cola. This wastes everybody’s time, preventing the server from promptly assisting every

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

Following aspects would a

one at her station.

(2) I don’t have time for dessert, nor the desire to reinforce a server whose skills are lacking, by or

dd to the challenges in developing combination products:

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

dering more.

(3) The server’s tips suffer. My rule of thumb is it’s a buck-an-error, if I’m having dinner. Some waiters hav

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

e lost five-spots this way. They earn less, quit more, restaurants have to recruit and train replacements, and more producti

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

vity and money are lost.

(4) They don’t just blow it with Cokes. When my medium-rare steak is delivered, burnt, it goes bac

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

k, and that is a pure loss for the establishment. Plus avoidable costs like these are reflected in higher prices for custome

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs. We eat out less often.

(5) Everyone grows irritated. Servers blame customers for their own errors, becoming visibly def

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

ensive. If I’m going to encounter an upset waiter in the future, I’ll take my business elsewhere. Again, more losses for eve

.

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

ryone.

The amount of money these listening errors costs cannot be known, down to the penny, but it has to amount to billion

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

Companies that provide selfless information through particip

s of dollars each year.

Wouldn’t it be cheaper and more pleasant for the restaurant industry to teach servers how to listen

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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