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You hear about all these mothers to be with morning sickness that last one day and some the entire nine months. Morning sickness can be very stressful and exhausting. It

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

can also wear down on the husband and wife causing tempers and bad moods.

In my opinion morning sickness should be called all day sickness, since your not sick just in t

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

Examples of combination products may in

e mornings. It's true because she was sick the entire day every day! My experience with my wife was around the first 24 weeks. She was sick for about 4 months and I mean

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

she had an upset stomach on average of about 4 times a day. I really felt sorry for her. I tried to get information from other mothers and friends to help her out. We hea

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

d and tried everything from ginger tea, sea bands, medicines, eat in the morning, crackers, small portions throughout the day and etc... None of these worked. She just c

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

Combination pro

ntinued on being sick, in fact sometimes she would even be sicker after using one of these "remedies".

So I realized that if she was going to be sick, she was not going

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

o be sick and uncomfortable. So here's what I did. Now before I go any further, I need to make something clear. What I did was to help her out and yes it did take work o

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

n my part and time from my schedule. That's what marriage is about, you make sacrifices and help each other carry their load. So I did a little rearranging around the hou

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

e. I would do dishes after dinner, I would make dinner sometimes, I cleaned the bathroom, I did laundry and folded. I would try to make her comfortable as possible. Inc

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

uding giving her blankets, massages and just talking with her about how she felt. She really appreciated those things, especially when I would clean the whole house for h

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

r and then we would just sit and talk. She would then talk to her mother on the phone and tell her all of her problems and how I helped her. Thats an awesome feeling.

I

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

Following aspects would a

know as a husband that coping with the morning sickness can be stressful. Worried about her all the time, also having to adjust your schedule because she's not feeling we

dd to the challenges in developing combination products:

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

l that eve. As in a cancellation of dinner plans with friends or family. It starts to drain us also, just in a different way. The key thing here is to not place any blam

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

on her. For example, "We never can go out because your always sick". Whoa Don't say that! That will start a fire that you can't put out. If you are having a tough time o

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

f it, just tell her in a different way. I told my wife that it is stressful on us both, but I know that she has a lot on her shoulders now. Explain to her that you're str

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

ssed, but also excited. What you want to do is just simply talk to her about your feelings. Really open up to her and just pour it out. As a husband I how now that my wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

e loves it when I tell her my feelings. Even if what I tell her isn't exactly what she wanted to hear. The communication thing is key here. Also while your pouring your h

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

art to her, ask her how she is feeling. Tell her you know she must be stressed out. But she is doing a wonderful job carrying your baby. Build her up also and give her e

.

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

couragement. Theres nothing like encouragement to a wife that comes from her husband. Don't forget the reason why you are in this situation. These are times that can be

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

Companies that provide selfless information through particip

eal nerve wracking, but also when you look back on them they will be some of the most rewarding also. You're ready to bring a new life into the world.

Author: Matt Bower

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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