Suggest - Relationships

Q:Thanks Jeff for the article on the signs of an emotional affair. Thanks also for

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 offer of telephone couseling/coaching. That would be good, however I in Asia and so 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

cost might be prohibitive.

Here's a brief overview of what is happenning to me: I've been

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

married for 5 years now and have three children and a wonderful husband. My concern is that

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

i have developed a close friendship with another man at work who is also married 2 years. We

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

Combination pro

've been friends for just over a year now and I've been feeling uncomfortable with the way i

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

feel about him lately. Is what I am doing OK or am I about to be in an emotional affair?
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
i>

A: My guess is that you already are in the beginnings of an emotional affair.

Th
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ere are two reasons I say this rather bluntly:

1. To jar you out of whatever denial you may
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
be in, and

2. If you are uncomfortable with the way you feel about this person, that is th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e greatest and most loud and noisy warning sign you could want.

Based on my experience with
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
these things, some if not all of the following things are taking place:

you thin
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
k about this person more and more often
you look forward to seeing this person
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
>
you have shared intimate emotional details about your life with this person

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
>you may have started to spend time alone with this person

These are all warning signs
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 an emotional affair and you need to pay attention to them.

Here are three things you ne
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ed to do:

1. Take my RLH prescription, which stand for Run Like Hell!

2. Begin to build an
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
exit door for this person in your heart.

3. Get some individual coaching and some relation
.

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
ship coaching. I have clients all over the world, it's just a matter of setting up the logis
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
tics on the phone.

Let's get started before you slide any further down this slippery slope.

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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