Advice Pool - Relationships

I often hear people scoff at women for staying in an abusive situation. They don’t understand why anyone would stay. It doesn’t seem that hard to leave. Just wa

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

lk out the door. Surely they haven’t lost the capability of turning a doorknob and walking out?! I understand their disbelief. With all of the available program

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

Examples of combination products may in

s for abused women, it seems they have many options. But maybe it’s not as clear-cut as it seems from the outside.

As a person who has been in that situation,

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

I can shed some light on the reasons a woman may have for staying. Sometimes it sneaks up on you. It's one instance of abuse in an otherwise good relationship.

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

It mounts little by little and you make excuses that they aren't really being abusive, things just got out of hand. It doesn't happen all the time and you wonde

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

Combination pro

r if you're blowing things out of proportion. Others have it worse. Finally it comes to a point where someone notices and points out to you that it's not normal

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

, you shouldn't have to live that way and you realize... you are in an abusive relationship. The kind you see on TV, or in the movies, or read about, but it's y

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

our life and you wonder how you got there.

From this point of realization, the battle begins. Not an external battle, that still continues, but the internal ba

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

ttle of the self-derision, the shame, and the internal questions. How could I let myself get into this situation? What will people think when they find out? Yo

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

ur whole self-perception shifts. I once thought of myself as a strong, educated woman, but if I’m in an abusive situation, so I must be weak. It’s one thing to

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

admit your weakness to yourself, but totally different to admit it to others.

Pride comes into play at this point. You don’t want your family, friends, and co-

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

Following aspects would a

workers to think less of you. Hell, you don’t want to think less of yourself! This is where many women are stuck. They can’t come to terms with their own weakne

dd to the challenges in developing combination products:

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

ss, seeing it as a negative instead of a fact of life. We all have frailties and we are stronger if we recognize this in ourselves and accept it as part of who

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

we are.

Some people stay in these relationships because they have nobody in their lives to point out that it isn't "normal" and they can choose another life. O

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

thers stay because they can’t get past the emotions long enough to get themselves together and out the door. It’s not as easy as just turning the doorknob and t

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

aking the step outside. First you must come to terms with the fact that you are abused. Next, admitting to yourself and others that you a human and, as such, ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve human frailties. Finally, you may need help to get out. Depending on the level of abuse, this could be difficult. Most abusers isolate their victim. They hav

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

e little contact with the outside world and are kept to a tight schedule. Finding an opportunity to contact help could be difficult, but not impossible.

Women

.

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

need to realize they are not lesser beings because they’ve been abused. They need to come to terms with it and find a way out. If you or someone you know is in

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

Companies that provide selfless information through particip

this situation, there is help available. Contact the National Domestic Violence Hotline at 1-800-799-SAFE (7233) for further information (http://www.ndvh.org/).

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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Advice Pool - Understanding Abusive Relationships

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