Summary - Relationships

At some point or another, we have all been there. We end up with a partner who has an imecapble resume. S/He is good looking, intelligent, career and famil

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

y oriented. After the honeymoon period, we realize that the relationship is eating away at our self-esteem, leaving us feeling uneasy and ambivalent. We be

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

Examples of combination products may in

gin to ask ourelves questions such as: what's going on here, but we got a long sooo well in the beginning, did s/he really say that, why am I putting up wi

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

h this? These uncomfortbale feelings and self doubt may be a sign that you in a Toxic Relationship.

What is a Toxic Relationship?

A toxic realtionship le

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

aves you:

Feeling bad about yourself, drained, uneasy, or uncomfortable

Feeling confused due to mixed messages

Feeling preoccupied or obsessed with your

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

Combination pro

future and the future of the relationship

Feeling too emotional or needy for wanting to spend alone time with your partner

Feeling too analytic for wantin

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

identify the discord or discuss the relationship issues

Feeling as if there is something wrong with you which needs to be fixed

Feeling that if you just

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

hold on a little longer things will go back to the way they were in the beginning

Why do we put up with these relationships?

1. We Rationalize: We begin

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

to make lots of excuses, and they usually begin with- BUT: But s/he is so stressed with work right now, But s/he didn't mean to say that s/he just had one t

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

o many beers, But s/he was just joking.

2. There are times when things are good: At times, our partner can be kind, caring, and charming. This behavior s

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

erves to offset our concerns and causes us to believe that things aren't that bad. If and when we contemplate breaking up with this person we think, "We ha

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

Following aspects would a

d such a great time the other night. We were totally in sync. Maybe things are changing." These good times are few and far between, and they usually come a

dd to the challenges in developing combination products:

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

ound when your partner senses that you are questioning the relationship.

3. Optimism: We believe that when the right time comes along we will be able to wo

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

rk things out. The problem is, it is almost never the right time. Or, we discuss the issues all the time and believe that we are working on the relationshi

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

p, yet no real change occurs.

4. Living in the past: In the beginning, things were great! As a couple, we had a great time together, really connected, a

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

d made some great memories. These memories serve to distort the real picture of what is going on. We hold on because we hope and pray that things will go

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

Professional from academic institutions, pharmaceutical industries, health care indust

back to the way they were.

5. Chemistry: We have great sexual chemistry with this person and mistake it for love.

6. Fear: At some level, whether we are

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

aware of it or not, fear exists. It could be fear of: loss, failure, never finding someone, never finding someone better, putting ourselves back out on t

.

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 dating scene. These fears hold us back from making decisions that honor our true selves and keep us from what we deserve.

Although toxic relationships c

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

Companies that provide selfless information through particip

an be difficult, we can work on them and through them. In part two of this article, you will find simple and practical solutions for your toxic relationship

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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Summary - The Toxic Relationship- Part 1

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