Suggest - Relationships

As far back as when I was in high school I noticed a funny thing going on. A couple would have been going out for a year of two, and one or bo

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

th sets of parents would start in with “The Question.” “When are you two going to get married ?” Some young couples I fear get married just s

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

Examples of combination products may in

o they don’t have to answer that question anymore ! So they get married. Then what do they hear ? “ When are you going to have a baby ?” These

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

two questions have always made me wonder, do we rush our young couples to marriage/parenthood?

Don’t get me wrong marriage and parenthood ar

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

both wonderful things ! Yet they are happier, and have a better chance of success if they occur when the people involved are ready. This can

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

Combination pro

mean a number of things. I have always believed every relationship has its own natural pace. The only two people who can accurately sense this

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

are the people in the relationship.

We also have to consider are the two people “relationship ready ?” Many couples coming out of high schoo

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

l for instance may be very mature, but many are not. Have the couple thought hard about how the nuts and bolts of how their marriage will work

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

? Who will keep the checkbook ? How do their views on childcare compare ? Where and in what type of dwelling will they live ? If they can’t gi

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

ve specific answers to these and many more important questions, they are probably being rushed.

What about being financially ready ? Does eit

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

her member of the couple have a full-time job? How does college fit into their plans ? Does either of them plan to join the military ? The mil

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

Following aspects would a

itary actually discourages its member from marrying in their first 2 or 4 years of service. This is because the salary paid the lower ranking

dd to the challenges in developing combination products:

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

embers of our military is not enough to support a family. And the people in charge know it !

I have nothing against young couples marrying. E

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

ven these days people do marry young and live happy lives together. Its just sometimes I wonder if we are really acting in the you couple’s be

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

st interest, or rushing to grandchildren. Rushing into marriage or parenthood at any age is very foolish. The thing with younger couples is th

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

ey are more likely to lean on the judgement of adults they trust. This is more than just a single sit down discussion. We always should be min

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

Professional from academic institutions, pharmaceutical industries, health care indust

ful of if we are unintentionally nudging things along faster than they should go. Of course the answer you get from the couple will probably

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

go something like “ But we’re so much in love !” Love is great, no marriage can succeed without it. At the same time we experienced couples kn

.

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

ow that love alone is not enough. This is one of those times when we need to tell the young people we care about what they need to hear, not w

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

Companies that provide selfless information through particip

hat they want to hear.

Don’t discourage them. Love them enough to make sure they take the time they need to make the right decision form them

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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