Advice Pool - Relationships

Every couple takes for granted that they will be able someday to have children. For some the problem of infertility is a slow growing realization. For others it comes as a shock after some months of attempting a pregnancy and then going for testing. In either case

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

, the emotions associated with it run deep.

On the one hand, there is the question of whether there will ever be a child who will look back at you with his mother’s or father’s eyes, one that will have her grandmother’s chin and her uncle’s devilish smile. On the

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

Examples of combination products may in

other hand, there is the feeling of being in some way inadequate. One looks at teenagers blithely muddling through pregnancies that are unplanned and undesired and wonders “What is wrong with me?” “Why don’t I deserve a child of my own?”

For most couples, both h

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

usband and wife have these feelings at times. When they are both struggling with these feelings, they can become disheartened, they can wonder what life would have been like with another mate, and they can wonder if it’s a cosmic comment on the rightness of their

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

atch.

Even more worrisome, however, is if one of them is going through these feelings and the other is at the same time optimistic or just unconcerned.

Couples who want to successfully survive infertility need to tune into each other, discuss things openly, be r

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

Combination pro

eady to listen to each other even when their thoughts are running in different directions.

Here are the major stumbling blocks to successful coping:

1. Not paying attention to your spouse

Even though he/she isn’t feeling the way you are about t

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

he problem or the treatments, his/her feelings are legitimate. You need to listen, understand, and not try to talk him/her out of his/her feelings. They are real. The more you try to shut them down, the stronger they will get, the more he/she will focus on them. T

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

lking about how one feels often helps one to clarify things and all the spouse needs to do is listen.

2. Over-sharing

You and your spouse need to decide who to tell and how much to tell. If one of you is uncomfortable with others knowing or with

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

a specific person knowing about the problem, you need to respect his/her sensitivities. Sometimes siblings, parents, and friends can be warm, helpful, and supportive. Some will keep your confidences and only be there to support you. Others will discuss your priva

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

te business with others and if that would upset you or your spouse, then you need to decide who should be told and how much. Once an agreement is made, keep to it. Don’t expect that you can tell someone not to tell your spouse and it will remain hidden. Secrets fr

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

m spouses are a very bad idea. Going through infertility is very stressful, keeping secrets from your spouse may be the death of a marriage.

3. Feeling unappreciated

Infertility can be a blow to one’s self-esteem. That seems to magnify other neg

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

Following aspects would a

ative feelings. Here’s a secret: more than 99% of all people feel unappreciated. No one can ever value you as much as you think you should be valued. If you are working, your spouse can never understand just how difficult and complicated your work situation is, an

dd to the challenges in developing combination products:

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

d if you are at home, your spouse can never appreciate how much work just maintaining a home can take. When feeling unappreciated begins to become a recurring theme in interactions with a spouse, you are headed on a negative course. Why? Your spouse, chances are,

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

also feels unappreciated. How can he/she worship you when you are not ready to worship him/her? You need to level the field, understand that real self esteem comes not from what others recognize in you, but what you recognize in yourself. I call it “becoming your

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

wn mother.” That entails looking at what you do and being able to say to yourself, “I put in a lot of effort” “I worked hard.” “I accomplished a lot today.” If you can care for yourself emotionally in that way, you will not have to drain your spouse for that kind

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

of reassurance.

4. Focusing on infertility

The relationship that you and your spouse share should be the most important relationship in your life. This should hold whether or not you have children. The marital relationship is the primary relatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

nship that provides security and love in a family. The focus of attention needs to remain on that relationship. Yes, you are working hard to achieve parenthood, but you are still a couple and you still need that relationship to nurture both of you. Sex should rema

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

n fun. It shouldn’t hold within it the disappointment of infertility. It should be something that you enjoy and that brings you close. Walks, candlelit dinners, flowers, and warm embraces help build the relationship. Laughing together helps you maintain a happy li

.

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

fe. Any future child will feel the security a good marriage provides. It is a priceless gift.

If you use your infertility as a springboard for personal growth and for increasing your understanding and affection as a couple, you will be using the time you are wait

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

Companies that provide selfless information through particip

ing to very good advantage. You will be a stronger, healthier couple and you will be building the nest that someday will hold your own little fledgling safely and securely.

Read more articles and personal infertility experiences at http://www.fertilitystories.com

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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