Summary - Relationships

It is never easy to have a relationship come to an end, regardless if you were the person to end it or on the receiving end. Heartbreak is

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

bound to rear its ugly head...the feeling that your heart is in 73 different pieces and you are not sure where to start piecing it back t

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

Examples of combination products may in

ogether. Trust me, I understand that feeling...

I made the decision to end a long-term romantic relationship with an absolutely incredibl

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

e man. I did not end this relationship because I no longer loved him, quite to the contrary. I ended the relationship because we lived 500

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

0 miles apart and the distance was really making things very difficult for both of us.

Frankly, I disliked the person I was becoming arou

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

Combination pro

nd the distance issue; always questioning, wondering when we could be together. It did not feel good to harp and it was eating away at bot

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

h of us. I realized that it was unfair to him and to me so I did the hardest thing in hopes of salvaging our friendship; a friendship that

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

means the world to me.

So what do you do when your heart is in pieces?

The first inclination might be to get in bed and pull the covers

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

over your head or to sit in a corner and cry your eyes out. Just know those feelings are natural and all a part of the healing process…

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

Feel your feelings through and try not to “stuff” them. Stuffing them will only prolong the healing process.

Talk about your fe

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

elings with someone you trust, someone who will be there to listen to you and support you. Often times sharing how you feel will help

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

Following aspects would a

you to work through the pain and provide you with the things you need to start healing.

Realize that you are going to have good days a

dd to the challenges in developing combination products:

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

nd bad and that is OK…some days will be easier than others. Remember, take it one step at a time and go easy.

Be kind to yourself.

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

This is probably the most important thing you can do. Try not to beat yourself up or call yourself names. You are already hurting, so

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

why add to it? Instead, try to do something nice for you…get out with some friends, take a walk, read a book.

Give yourself time to h

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

eal. It is not uncommon to want to jump into another relationship when you are hurting. In doing so you are not giving yourself the ti

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

Professional from academic institutions, pharmaceutical industries, health care indust

me you need to resolve your feelings or to let go of any pain. Not only is this unfair to you, but it is also unfair to the new person in

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

your life.

Trust yourself that you will do what you need to do to heal and move forward.

Please just be good to you and take care

.

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

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

Companies that provide selfless information through particip

nk to What’s Within U (www.whatswithinu.com), copyright notice, and author’s name.

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 - 73 Pieces; Where's the Glue?

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