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The Appalachian trail is a 2000+ mile trail that starts in Katahdin, Maine and ends at Spring

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

er Mountain in Northern Georgia. The trail will take its travelers through Maine, New Hampshi

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

Examples of combination products may in

re, Vermont, Massachusetts, Connecticut, New York, New Jersey, Pennsylvania, Maryland, Virgin

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

ia, West Virginia, Tennessee, North Carolina, and Georgia. The trail first opened as a contin

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

ous 2174 mile trail in 1937. One of the amazing parts about this trail is that every year tho

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

Combination pro

usands of people flock to the Appalachian trail to attempt to thru-hike, which means to hike

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 entire trail from end to end. Of these people only some 30% will actually be successful i

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

n their task. The rest will either give up, get injured, or have to leave the trail for some

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

ther reason.

People can either hike the trail as Northbounders hiking from Georgia to Maine

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

or Southbounders hiking from Maine to Georgia. In either direction you are bound to pass othe

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

r hikers coming in the opposite direction. Local trail clubs have setup shelters all along th

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

Following aspects would a

e trail and generally about a day's hiking distance in between each shelter. To hike the enti

dd to the challenges in developing combination products:

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

e trail you should plan on spending anywhere from three to eight months on the trail. Plannin

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

g the logistics for the trip and getting your body conditioned for the daily rigors will take

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

several months to several years depending on your budget and physical conditioning.

Packing

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

and planning are going to be two of the most important parts of your trip. When it comes to

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

Professional from academic institutions, pharmaceutical industries, health care indust

ear your primary concern should be weight. You have to carry everything your take with you so

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

plan on taking only what you need. There are no fees for hiking the trail but it will end up

.

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

costing somewhere between $2000-$4000 in miscellaneous expenses along the way. Hiking the en

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

Companies that provide selfless information through particip

tire trail can be an amazing experience but requires a lot of preparation and careful plannin

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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