Advice Pool - Reference and Education

Pick up a book about Bigfoot and you'll find lots of sightings, lots of photos

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

of Bigfoot researchers, but very little of one ingredient: theories. An awful l

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

Examples of combination products may in

ot of Bigfoot researchers pride themselves on their lack of theorizing, on thei

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

r dogmatic refusal to consider any theory about the nature of Bigfoot. "I don't

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

have a theory," they might say, "I just investigate the sightings." About 30 s

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

Combination pro

econds ago, I named this attitude the No-Theories Theory. On the surface, the s

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

tatement sounds reasonable, and even noble. You don't formulate theories, you j

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

ust gather sightings.

Why?

Why talk to witnesses if you have no interest in e

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

xamining the data, forming hypotheses, and debating the merits of those hypothe

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

ses? Proponents of the No-Theories Theory collect sightings, toss them in a dat

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

abase, and forget about them. Maybe they run some software that spits out a few

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

Following aspects would a

statistics about the average height or weight of Bigfoots. Maybe the statistic

dd to the challenges in developing combination products:

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

s show Bigfoots mainly eat meat on Tuesdays.

As I discussed in my Semantics Se

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

ries posts, Bigfooters don't like to admit they believe in Bigfoot. If you can'

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

t admit to believing these creatures exist, then it makes sense that you avoid

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

developing ideas about what they are and how they fit into the grand scheme of

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

Professional from academic institutions, pharmaceutical industries, health care indust

life. If you subscribe to the No-Theories Theory, stop and ask yourself one que

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

stion: What is the point of your research?

Don't fear theories just because on

.

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

e day someone might prove your theory wrong. Investigate, ponder, theorize...an

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

Companies that provide selfless information through particip

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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