Suggest - Relationships

Like so many people, F. had suffered an emotionally deprived childhood. She tried to make sense of that world more or les

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

s unsupported. When I asked her what, for her, were the 5 most important qualities in a relationship, she looked at me li

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

Examples of combination products may in

e I was an idiot.

The first thing she named was the one whose lack she had felt most keenly in childhood: communication.

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

Because she hadn’t had it she assumed that it would be the panacea for all evils: that talking would be enough to ensure 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

at two people share the same beliefs, attitudes and values. If only.

Then came monogamy. After monogamy came integrity.

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

Combination pro

Then commitment. You can see what F.’s partner had put her through.

I pointed out to her that she was still one thing

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

hort. She was struggling now. Eventually she came up with ‘love’. When I asked her what ‘love’ meant to her, she talked

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

about faithfulness, commitment and communication.

Now, I’m not knocking any of these values. They all have their place a

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

d I wouldn’t want to be in a relationship without them. But the point is: were they enough to sustain and nurture her? W

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

hen I asked her that question she was visibly thrown. She had thought of relationships in terms of what she gave, not wha

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

she received. The net result was that she received very little that was not damaging.

It’s a useful question. Do those

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

Following aspects would a

ualities that you deemed the most important in a relationship sustain and nurture you? Or have you chosen them reactively

dd to the challenges in developing combination products:

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

in an attempt not to experience old hurts again?

How would you like to be treated in a relationship?

What kind of treat

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

ment do you need to feel:

· Loved
· Respected
· Cherished
· Safe
· Equal
· Happy
· Confiden

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

· Valuable
· Honoured

The list could go on and on. Maybe you would go for different things. Maybe you hadn’

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

given it much thought. Maybe you don’t find it easy. It might take you a while, and a good few pieces of paper, to becom

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

Professional from academic institutions, pharmaceutical industries, health care indust

clear about what really matters to you. Still, it’s worth doing. Far better to spend 5 or 10 minutes, now and then, wri

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

ting what you want down on paper now, than to end up in another damaging relationship.

There is no reason on earth that y

.

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

u should not feel loved, respected, cherished, safe etc, provided you have freedom of choice. It’s your right. Establish

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

Companies that provide selfless information through particip

ng what matters most to you in a relationship, and being as clear as you possibly can, is the key to exercising that right

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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