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Have you ever had a panic attack? Have you ever felt so scared and panicky but had

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

no idea why?

Panic or anxiety attacks are suffered by a large number of the popu

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

Examples of combination products may in

lation and they are very, very scary. Especially the first one, when you have no i

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

ea it is coming and no idea what is happening to you.

What are the symptoms of pa

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

nic attack?

Symptoms include:

A racing heart accompanied with an anxio

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

Combination pro

us feeling

General anxiety about every day life

Scary thoughts and feeling like

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

ou’re losing control

Dizziness and light headed

Sweating, shaky and even weak

F

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

eelings of unreality and perhaps even disorientated

Feeling like you just want to

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

run away

Can’t relax, feel like you’re ‘on the edge’

Sometimes you feel dep

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

essed and anxious for a couple of days leading up to a full blown panic attack and

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

then after the attack you can feel very tired and have a general ‘feeling down’ f

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

Following aspects would a

eeling for a few days following.

When you have a panic attack your body thinks so

dd to the challenges in developing combination products:

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

ething is happening that it needs to fight against, so you have an adrenalin rush

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

as your body prepares itself for battle. Then however, there is no battle and all

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

that adrenalin is left in your body making you tense. Your body can also feel very

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

tired and run down after the adrenalin rush.

Your mind can’t relax because you ar

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

Professional from academic institutions, pharmaceutical industries, health care indust

e constantly thinking about the attack and absolutely terrified of it happening ag

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

ain.

If you experience panic attacks like these quite often it can really effect

.

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

our life. You can spend your life scared and depressed.

Try to remain positive an

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

Companies that provide selfless information through particip

d try to distract your mind by keeping busy. Seek treatment for your panic attacks

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 want to say something quite clearly and emphatically, and ask you to repeat it to yourself a few times: MY COMPENSATION IS ENTIRELY ARBITRARY! For example, let’s say you write computer programs for a software company that packages your “code” into products that it sells to customers. You will probably be paid a salary, perhaps earn an annual bonus, and accrue some vacation time. You may also get some benefits, including a partially paid health plan. All of this seems so normal, so typical that you never question this menu of dollars and perks. Sure, you may want a greater helping of salary, but still, as long as there is a salary and a few other goodies, you’re set. But what if one of your software programs really takes off in the marketplace? Will you be entitled to receive royalties from it, have any ongoing equity interest in it, or ever be able to claim a bigger desk, a reserved parking space, or any material advantage from its performance? The short answer is “no,” not because you can't, but because it isn't traditional and you haven't negotiated for it, says Dr. Gary S. Goodman, best-selling author, keynote speaker and seminar producer, and Fortune 1000 consultant.

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