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Question From A Reader: Since the divorce stuff started, I have been trying to talk to differen

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

t women as it has been 7 years since I have been single.

I met this one woman who is very inte

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

Examples of combination products may in

resting, we have exchanged several long emails, text messaged each other, talked on the phone,

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

nd had dinner together, all in about a week of knowing each other.

Now, I am not trying to jum

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

p back into anything serious and I don't want to rush into anything either.

However, I really

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

Combination pro

ike this woman and want to get to know her better and she already knows I am going through a di

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

vorce.

Can you give me some tips on subtle ways I can let her know that I am interested in her

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

as more than just a friend?

Answer:

The first thing you need to do is slow down, relax, and

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

erhaps get some counseling to help you through your divorce.

You are going through a divorce 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

nd need some emotional support and this woman is providing that for you.

However, you want som

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

thing more from it and already know that it is not a good idea to rush or get in anything serio

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

Following aspects would a

us right now.

When you are going through a divorce getting serious and rushing things with a w

dd to the challenges in developing combination products:

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

oman is not what you need to do.

Yet, it is essentially what you are doing with this woman or

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

t least getting ready to try and do.

Several long emails, in combination with text messages, t

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

alking on the phone, and having dinner together, in the span of a week; qualifies as both rushi

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

g things and becoming serious with her.

Getting sexually involved or being more than just frie

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

Professional from academic institutions, pharmaceutical industries, health care indust

nds with her at this point in your life would be a huge risk and mistake on your part.

Hopeful

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

ly she already understands this but why take that chance, by trying to make a move on her.

The

.

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

best thing for you to do is get some counseling or continue to lean on her for emotional suppor

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

Companies that provide selfless information through particip

t and find yourself another woman to have a casual fling with, without the emotional attachment

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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Have you even seen those old couples that look so friendly towards each other? Would it be wonderful if we could be friends and lovers at the same time? I know a few couples who have become friends: theirs is a strong marriage and they have the time of their lives.

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