Write You - Writing and Speaking

The most valuable tool of the freelance writer or author is undoubtedly a notebook. Inspiration can

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

strike at any moment, and usually does so at the most unexpected time. It is wise to always have 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

notebook and pen with you, especially beside your bed, to capture those elusive morning inspirations

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

and ideas, before they evaporate with the coming of the day. The subconscious mind misses nothing

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

and is your best ally.

An invaluable tip for w

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

Combination pro

riters is this -- during that dreamy state between awake and asleep, before you fall asleep, simpl

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

y ask your unconscious mind to help. Ask it to come up with some relevant ideas on the project you

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 working on. Go over it in your mind several times, then, very often, on awakening, new ideas cou

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

rse through your mind, courtesy of your subconscious. Song-writers, including Sir Paul McCartney, h

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

ave used this technique to great effect when trying to think of new lyrics and melodies.

If you fin

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

d it easier to ‘speak’ your ideas and inspirations, then perhaps it is worth investing in a small po

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

Following aspects would a

rtable dictaphone type recording machine, and having this with you at all times. They repay the cos

dd to the challenges in developing combination products:

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

t many times over by keeping all your dredged up ideas and inspirations safe for you to later transc

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

ribe.

A small notebook and pen is easily managed by most people, slipping easily into handbag or po

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

cket. A good rule of thumb is to write down all ideas, no matter how outlandish or unrealistic they

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

may appear at the time. Plenty of time to later copy them into a word document, and at the same t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ime, re-evaluate their worth.

It is important to get into the habit of keeping it with you at all t

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

imes, add it to the list of items we always take with us, such as keys, and mobile phone. In this w

.

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

ay, when that million dollar idea strikes, you will be ready and will not let it slip away with the

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

Companies that provide selfless information through particip

morning sun.

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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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