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I recently received a letter from someone who has been married for a number of years. The letter described a couple w

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

ho has gradually drifted away from each other. They sounded like great parents but their marriage had grown cold. Th

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

Examples of combination products may in

writer ended the letter with a request for a suggestion to rekindle the romance within the marriage.

Usually, storie

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

s like this start with unresolved resentments and feelings of hurt. When conflicts arise and the issues are not clear

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

y addressed, the couple will begin to put distance between each other. This process can occur rapidly or gradually ov

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

Combination pro

r time. The couple may present well to everyone in the community, but what is really happening within the home is qui

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

te different. The couple may share more of a roommate type situation as compared to a loving, marital environment.

S

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

, what can a couple do to overcome a predicament like this? Here are a few quick suggestions.

1. Take a mini vacatio

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

n with your partner about every six weeks. This does not have to be anything elaborate. It may consist of going to a

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

nearby town and checking into a motel for a night or two. It is essential that couples get a break from the usual rou

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

ine. This is refreshing to the marriage. P.S. The children will need to stay with grandparents or a sitter.

2. Sch

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

Following aspects would a

edule a "Date Night." Go to the movies, out to dinner, to the park, a walk through the mall, window shopping. Make y

dd to the challenges in developing combination products:

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

ur spouse a priority and stop giving regular excuses of work and children.

3. Pray together as a couple. This needs

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

to be done in addition to the blessing at meal times. Praying together helps to remind us of the vows we made to each

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

other. As a result our commitment to the marriage and the needs of our partner are reinforced.

4. Kiss your partner

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

ore often. Tell them that you love them. Reach out and hold his or her hand. It is amazing how couples can talk abo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ut certain issues, and by simply holding hands, an argument is prevented. Holding hands conveys love and reassurance.

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

5. Couples can reconnect rather rapidly by simply saying things like, "I miss you." And "I’m sorry."

Never give up o

.

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

n a good thing. If your relationship is generally good or was once great strive to recapture what you once had betwee

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

Companies that provide selfless information through particip

you. Let your partner know that you think the relationship is worth fighting for. Then give 110 percent of yourself

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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