Suggest - Relationships

With the passage of time relationships can tend to fall into some negative and positive routines.

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

Many of these contribute to the nurturing of the relationship while others can undermine its succes

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

Examples of combination products may in

s. One of the things I have discovered over the years is that developing some rituals can ensure t

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

hat the relationship stays on a positive track. Although no relationship is perfect (or ever will

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

e) and experiences ups and downs these rituals can help keep the relationship focused on those atti

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

Combination pro

tudes, behaviors and feelings that you want to see continue.

Let me give you a few examples of som

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

e of the rituals I have come across over the years. Some of these have come from friends, some pee

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

s and others from members of my audiences who have shared them with me.

1. Have a date night on t

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

he same day of the week or days of the month. This date night isn’t subject to cancellation regard

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

less of career or other issues. It takes priority no matter what.

2. Spend one day (or portion of

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

a day) at least once a month discussing the positives in your relationship as well as some of the t

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

Following aspects would a

hings you would like to change.

3. Play odd and even. Each partner is either odd or even (not in

dd to the challenges in developing combination products:

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

personality but the day of the week, week of the month or month of the year. If you are odd that m

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

eans you call if you are out of town on odd days, even days your partner calls. Odd years you get

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

o choose where and when you vacation, even years it is your partners choice. You can have some fun

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

with this. It can include things like: who cooks, initiates sex etc.

4. Once a quarter one par

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

Professional from academic institutions, pharmaceutical industries, health care indust

tner surprises the other with a special weekend retreat. Take turns.

5. Every morning one partne

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

brings the other coffee and juice while the other sends flowers or some small token that says you

.

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

are special. - I thought of you today and I want you to know I appreciate you.

6. Your turn. Wh

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

Companies that provide selfless information through particip

at are some rituals that you have in your relationship that keep it centered, focused and on target

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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