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For those of you who don't know, Malaysia has very, VERY tight regulations on sports suppl

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

ements and you are unable to purchase most of the new stuff that hit the shelves overseas

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

Examples of combination products may in

ere in Malaysia. Maybe the US FDA is not good enough for some doctor that bums in the gove

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

rnment office I suppose? I'm not talking about steroids or anything illegal here.

Not onl

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

that, if you were to attempt to get it shipped to you, it would be confiscated by the Mal

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

Combination pro

ysian Customs. So we Malaysian fitness enthusiasts have to be content by just reading the

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

amazing product reviews and drooling at the ads in bodybuilding magazines.

Anyway, I was

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

retty excited when my friend who is holidaying in Canada told me I could have my orders fr

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

om bodybuilding.com shipped to his place there and he could bring them back for me here in

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

Malaysia. I quickly browsed through the Bodybuilding.com 2005 award winners to quickly gau

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

e popularity and effectiveness, and decided on ordering the following (1 of each):

1.

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

Following aspects would a

Muscle Builder Of The Year - BSN NO-Xplode

2. Nitric Oxide Product Of The Year - BSN NO-

dd to the challenges in developing combination products:

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

plode

3. Multi-Vitamin Of The Year - Universal Animal Pak

Total cost is USD 100.8

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

7. Thats almost RM400. VERY cheap I would say. If these were sold here (we wish).. the cos

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

would easily exceed a thousand ringgit I bet (which up till today, I fail to understand).

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

With my shopping list all set, I decided to just read up on their shipping policy, and th

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

Professional from academic institutions, pharmaceutical industries, health care indust

ats when I came across this page - "y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

e/help/illegal.htm">What products are illegal in my country?".

It basically says that

.

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

the stuff I wish to ship to Canada, is considered illegal in their country. Darn... That

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

Companies that provide selfless information through particip

ust ruined my day. Guess I wont be having the chance to try something new for the new year

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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Many industry sectors have abatement professionals and consultants and there are even trade journals specializing in these things. Unfortunately the greatest abatement consultants are so busy that they generally cannot even return phone calls as they travel the world putting out fires and handling crisis management.

I'll bet you don't have a clue as to what I am talking about – Sea Gull Management.

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