I Suggest - Cancer

You don’t feel any different, except for little things here and there that are more annoying than frightening. Your life has been good, just like ev

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

eryone else’s: some ups, some downs, some exhilarations, some crisis. Nothing truly extraordinary. You work, you pay taxes, you have a family, you a

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

Examples of combination products may in

e satisfied, you have friends, pets, co-workers, children, partners, a car or a house, or both, you have credit cards, you eat all right, you groom

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

ourself, you make love, and so on and so forth. You think your life is ok; you know you are ok.

Then just like that, something in you appears to be

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

a little funny. So you make an appointment with your physician. Next thing you know, you are swarmed with physicians, exams, tests, and finally the

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

Combination pro

iagnosis. It is cancer. You panic. You feel disbelief. Me? No way. I am so healthy! Everyone panics. You? Impossible. You are so healthy! You always

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

felt so good! You don’t feel any different. But now things have changed permanently in your life.

First comes the pressure. Urgency is required. Yo

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

are not allowed any time to think things over and decide what you want to do and how you are going to do it. Conventional wisdom tells you to do th

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

ee things: surgery, radiation, chemotherapy. People expect you to do them, the medical establishment demands you do them. You think you have no choi

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

e. You don’t know better. You are now very afraid you are going to die.

Though the hurry may seem justified, there are 3 things you need to do befo

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

e taking action:

1. Accept responsibility for your own life; your own doings, your own healing.

You and only you can decide what course of action

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

Following aspects would a

to take and when. After all, it is your life and no one knows it better than yourself. Be grateful for the support you receive from others but do wh

dd to the challenges in developing combination products:

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

t you think is best for you.

2. Take time for yourself.

When they know you have been hurt (or, yikes, diagnosed), people will want to speak with y

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

u; they will want to help you, they will want to see you. Accept their help but take time to concentrate.

Give yourself time. Go on a retreat, if y

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

u can, or spend quiet time in prayer and meditation. Be silent. Be still. Ask Spirit for the best course of action. Pray for inspiration and wait. I

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

will come to you.

3. Go deep into your wound

Whatever it may be: cry, grieve your losses, go to your underworld if you must (just like Orpheus).

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou will come back from it a much stronger person. Do what you need to do without pretenses. You must be true to your hurt, to your feelings. Your ac

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

eptance that you are hurt is your biggest step for your true healing. Just don’t dwell in the question “Why” because you will have no answer that wi

.

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

l satisfy you. On the contrary, it will do you no good. Forget that one and you will feel better.

Taking these first steps will do an incredible am

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

Companies that provide selfless information through particip

unt of good. Then, you will have your decision. Follow it with an open heart. Know that everything that happens to you happens for your highest good

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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I Suggest - So you have Cancer - 3 First Steps for your Consideration

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