Answers - Relationships

I asked my husband out on a date for next weekend. He paused for a second before he said yes. That was weird. Why did my own husband pause when I asked him out? He was trying to figure out 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

hat I meant by, "Would you like to go on a date next weekend?" Your guess is as good as mine as to what he thought I meant. Clearly, we don't do this often enough.

For my husband and I eating

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

Examples of combination products may in

inner alone in a nice restaurant doesn't happen a lot. Experts say Date Night should happen once a week. Those experts' kids must be in college. Or maybe they never had kids. Whatever. I fig

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

re if my husband and I can reconnect in a romantic atmosphere once a month or so, we're doing pretty well. We're not heavy romance kinda folks, anyway. Grabbing an ice cream treat at the Dari H

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

t and bringing it home to surprise my husband in the evening is fun with just a nice enough touch of romance. For me personally it's about the time we spend together-- not what we're doing-- tha

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

Combination pro

matters.

For our upcoming date night I have everything planned. I have my outfit all picked out. I lined up Grandmom & Poppy to baby sit our two little girls, ages two and four. I made reserv

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

tions at a restaurant that has tablecloths and a piano bar. We’re both looking forward to it, but I have to say, I am feeling a little nervous. Because we don’t spend a lot of time alone togeth

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

er these days, I thought it might be a good idea to establish some “ground rules” for our date. These rules could help you, too, if you spend more time in Family / Mom & Dad Mode than you do in

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

omance / Husband & Wife Mode. Here are the rules I came up with:

1. Set a pre-established time to talk about "business": the kids, the house, finances, work, etc. When the time elapses, stop.

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

OK, so what topics does that leave? Do you remember what it was like to date your spouse? Before you had kids? Before you lived in the same house and shared every intimate detail of each othe

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

's laundry and other personal habits? No? Join the club. For conversation starters, you might have to do some homework. Read a book so that you can share the plot over salad. Find an interes

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

Following aspects would a

ing story to share. Ask your spouse about his favorite restaurant as a kid. Or what was her best Christmas/Hanukkah/birthday gift ever? Or what was his favorite part of your honeymoon-- you co

dd to the challenges in developing combination products:

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

ld even bring a few photos with you to jog your memory. Just because you're married doesn't mean you know everything. There’s a still ton to discover.

2. When one of you veers off-course (whi

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

h you likely will), the other should gently guide the conversation back to more partner discovery. If he says, "That little league game was great! I was so proud of the way Johnny caught that f

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

ly ball." She can say, "I'm proud of him, too. I'm also proud of what a great Dad you are. The first time I was proud to be with you was when...." See? A gentle transition away from the kids

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

and back to memories of you.

3. Flirt with each other. Use your non-verbal messages in that "come-hither-after-dinner" way. Why not? You ARE married, after all!

4. Order dessert. Forget a

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

Professional from academic institutions, pharmaceutical industries, health care indust

out your diet. Indulge a little. It's not like you do this all the time. Don't order the fruit cup with a tiny little plop of Grand Marnier cream, unless you live in Alaska, it's the dead of w

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

nter and you miss fresh fruit-- or that's what you REALLY want.

5. Laugh.

6. Hold hands. Share a few bites of each other's dinner. Look at each other. See #3 above.

I hope you have a chan

.

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

e to use these rules with your spouse soon. If you don’t already have your next date night planned, here’s your opportunity to plan one. Do it right now while you’re thinking of it—even if you

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

Companies that provide selfless information through particip

ave to plan it for a couple of weeks down the road. Then you’ll have something fun to look forward to and a few rules to help you enjoy the evening when it does arrive.

© 2007, Felicia Slattery

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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