Summary - Health and Fitness

In my favourite coffee bar you need to stand in line to be served, then you can find your seat; if you are alone that

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

is. It’s one of my pet peeves that I can standing patiently waiting my turn and a couple can walk in, one takes up sta

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

Examples of combination products may in

ion in the back of the queue the other plonks themselves down on the chair I was seconds from occupying once my cappuc

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

ino was ready.

On this occasion I was lucky, I managed to get my preferred seat and settled into a pleasant caffeine

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

fuelled scribbling session. After a little while the shop got busier and a queue began to form. Two middle aged women

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

Combination pro

ame in, one dropped her bags in one of the free chairs and herself in another, while her friend joined the queue.

Eve

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

though I had my chair, the unfairness of it rankled. The moment she put her bags down I began to dislike her, once th

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

at judgement was made my mind went on a mission to find other things to dislike about her. In a very short space of ti

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

e everything about her was beginning to rankle: the (imagined) contents of her fancy shopping bag must be trivial, the

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

way she fussed about was annoying, her clothes, her hair style ….

Suddenly I had one of those peculiar moments of cla

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

ity where you can see the workings of the mind while it is going on, which is the aim of meditation. Unfortunately at

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

Following aspects would a

moments like this what you notice isn’t very appealing. I had uncovered a pattern that began when I judged the women f

dd to the challenges in developing combination products:

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

r the first time. Then I started to look for things to justify my judgement, which fuelled my resentment. The growing

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

esentment encouraged me to look and find more (ridiculous) reasons for more resentment and so on.

A unpleasant and po

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

intless loop of judgement, resentment and justification. The results were quite unpleasant for me, it was a very nice

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

xample of what Buddhists would call suffering, a self inflicted distress that has very little to do with the outside w

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

Professional from academic institutions, pharmaceutical industries, health care indust

rld. The process is a very familiar one and doesn’t just happen in coffee shops, and I don’t think it’s just me. I’m p

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

retty sure that just about everyone from time to time goes in search of evidence for the prosecution, feeling both jus

.

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

ified and unhappy at the same time.

I was reminded of a quotation I once saw on the wall of a Buddhist monastery duri

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

Companies that provide selfless information through particip

g a meditation retreat which sums this up.

In a moment’s judgement, heaven and hell are set infinitely apart!

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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Summary - Coffee Shop Suffering

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