References - Travel and Leisure

I was living in Siberia for a year in the City of Chita. While it may sound dramatic and exciting, that di

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

dn’t keep me from needing some basic things like pants!

Shopping For Pants In Siberia – In the Winter!

S

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

Examples of combination products may in

iberia is an amazing place. Yes, it is colder than you can imagine in winter, but it also gets hot, hot, h

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

ot in summer. While living there, I reached that magical point where I needed to buy some new pants. Alas,

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

this happened during winter and it was an eye opening experience to say the least.

The city I was in, Ch

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

Combination pro

ita, does have indoor stores, but they are expensive. Most people purchased needed items from outdoor kios

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

k in areas that were set up like swap meets. The quality of the products was fine, so who could really com

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

plain. When I determined I need some new jeans, I grabbed a bus and headed off the swap meet dejure.

Afte

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

r walking around for a bit, I found the perfect kiosk. Not only did they have jeans, it was all they had.

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

Unfortunately, they only had a few sizes of “levys”, but one was mine. So, where can I try these swank Chi

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

nese rip-offs? After a bit of finger pointing and pantomiming, I was pointed to a hanging carpet. Behind w

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

Following aspects would a

as a nice little bench sitting on the asphalt. When in Rome…

Now, I don’t have any real problem with roug

dd to the challenges in developing combination products:

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

hing it when necessary. I was, after all, in SIBERIA. Still, I was not about to try on the jeans in the mi

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

ddle of a parking lot in January in Siberia. At 30 degrees below zero, I was already plenty cold. I sure a

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

s heck was not removing my pants. [Insert joke here!]

I explained my predicament to the Russian running t

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

he kiosk. Pantomiming was again involved. Ah, he understood my problem. In a classic Russian moment, he pu

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

Professional from academic institutions, pharmaceutical industries, health care indust

lled a vodka bottle out and offered me a slug. I passed. Even with vodka to warm me, there was no way I wa

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

s dropping my pants. Just not going to happen.

As with many moments in Siberia, the answer was a compromi

.

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

se. I was introduced to the vendor’s friend who took me to his flat to try on the pants. Wouldn’t you know

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

Companies that provide selfless information through particip

it, they fit! Rubles were exchanged, vodka was consumed and I had a new pair of pants. Ah, life in Russia

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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