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1. Take responsibility for your own actions. There is nothing more guaranteed to prolong conflict than excuses of the type: “If you

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

hadn’t done X, then I wouldn’t have done Y.” If you own your own stuff, then you leave your partner free to do the same.

2. Apologise

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

Examples of combination products may in

at the first possible opportunity. The “S” word, sincerely used, has almost magical properties. There are no prizes for never being 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.

he first to say you’re sorry. It doesn’t make you look strong. Failure to make sincere apologies will damage your relationship.

3 Li

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

ten. Instead of trying to justify your behaviour, make the effort to listen in respectful silence. Hear your partner out without butti

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

Combination pro

ng in with excuses, counter accusations. Yes, you might be worried about what you will hear, but if you don’t add fuel to the fire with ill

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

chosen words, your partner’s sense of grievance will subside much more quickly.

4. Talk about your feelings, not their b

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

haviours. If you stick with “I” statements, rather you than “you” statements, your partner won’t feel criticized and will be far more l

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

ikely to empathise with you. Doing this creates a safe dialogue.

5. Practise taking time out. Damaging words and behaviours happ

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

en in the heat of the moment. Learn to right walk away from an argument and simply breathe for 5-10 minutes, when you feel you are getting

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

ngry. Better still, choose a word or phrase that you and your partner can use as a signal meaning “time out”. Honour it.

6. Agree to

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

Following aspects would a

timetable quality time together each week and prioritize that time. Relationships need nurturing. You have to lavish time and care on

dd to the challenges in developing combination products:

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

your relationship - and each other - if you want it to thrive.

7 .Make time to tell your partner how special he or she is. Be as

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

specific as you can be about what makes him or her special and why it means so much to you. Not only will you both become more aware of yo

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

r partner’s specialness, but in time he/she will probably say the same kind of things back to you.

8. Tell your partner how much you l

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

ove him or her. Do that at least on a daily basis. You can use notes, cards, quotes etc. to reinforce the idea. Never assume that he/

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

Professional from academic institutions, pharmaceutical industries, health care indust

she doesn’t need to be told, or doesn’t like to hear, all the things that you love about him/her.

9. Hug your partner daily. Virg

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

nia Satir said: “We need 4 hugs a day for survival. We need 8 hugs a day for maintenance. We need 12 hugs a day for growth.” Why not go f

.

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

or growth?

10. Share. Share laughter and joy daily. Make a conscious decision to share your wins and rejoice in theirs. What yo

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

Companies that provide selfless information through particip

u focus on increases, so focus on what is great about the relationship and great about your life together and it will keep on getting better

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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