Summary - Relationships

There are two kinds of history in a long term love relationship.

The first ki

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

nd is the history you bring to the relationship. The second kind is the histor

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

Examples of combination products may in

y yoy create in a relationship.

The history you bring to a relationship
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

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All of us have a relationship history. Our relationship history is made up
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
f the relationships we have had, what happened in these relationships, and wha
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
t we believe we have learned.

This kind of history influences who we choose 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
o be in relationahip with, and how we view events in the current relationship.
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

Paying attention to this kind of relationship history can help us choose bet
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
er partners and not repeat the same mistakes.

The history you create in a
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
relationship

Then there is the history we create in a relationship. While
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
we want to create only positive history, in any relationship of any length, t
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
here is going to be some negative history as well.

One of the challenges face
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
by the couples whom I coach is what to do with this history when you are tryi
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ng to change and improve the relationship.

I think you need to be able to do
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
at three things with this history:

1. Pay attention to the history.

2. Learn
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
from the history.

3. Occasionally tell the history to Shut Up!

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

Professional from academic institutions, pharmaceutical industries, health care indust
what I mean.

There are times when a couple or a person is trying to change w
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
here history will whisper in your ear things like:

"He/she is never gonna cha
.

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
nge."

"You know you can't get better."

Etc.

This is when you need to tell h
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
istory to shut up, so you can create some positive history in the 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 - Relationship Advice: H is for History

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