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Do you have a speech impediment? Are you looking at ways in which you can overcome your speech i

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

mpediment? Do you hate your speech impediment? Does your speech impediment dictate your life? Up

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

Examples of combination products may in

until around ten years ago I would have answered yes to all of these questions but have now man

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

aged to achieve fluency and life has never been so good.

My own speech impediment started when

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

was just four years of age, well this is what my parents have told me. I had for whatever reaso

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

Combination pro

n developed what I call a stammer or what most people call a stutter. Looking back this must hav

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

e been a huge cause of concern for my parents and it would have been difficult for them to know

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

here to look for help. Now that I am a parent myself I can understand what it must have been lik

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

e for them.

My parents decided to take me to speech therapy in a quest to cure the speech imped

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

iment. I, as such a young boy did not want to go as it was not somewhere that any of my friends

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

ad to go. I have to admit that I do not remember much about these early speech therapy lessons.

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

Following aspects would a

In my teenage years I continued to search for some sort of stammering cure and was desperate to

dd to the challenges in developing combination products:

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

find some solutions to the speech impediment. I was starting to get frustrated with life and es

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

pecially speech therapy. I had been going for years and had not improved one bit. I also had qui

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

e a bad attitude to the whole process, you have never had a stammer so how do you know how it is

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

affecting me, this is what I used to think about these speech therapists who were attempting an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d failing to help me.

There are many different types of therapy for a stutter including one-to-

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

ne speech courses, group courses, hypnosis, self help dvds and self help ebooks.

I managed to o

.

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

vercome my own stammer ten years ago after basically studying how what I call the best talkers s

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

Companies that provide selfless information through particip

poke and then copying them. My confidence has improved in a big way and life is now a lot easier

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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When you speak alot you run into some crazy room setups. It's your job to be there early to make sure all the little preparation details taken care of. One of these details is the visibility of you and your visuals from each chair in the audience.

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