Advice Pool - Health and Fitness

I was sixteen year old, a strong youth, but kind of on the chunky side. One day, the older brother of a friend of mine, told me that I should come down to the Gym with him. Thi

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

s sounded exciting; I was never in a gym before ( the year was 1966, availability of gyms were small). The next evening, we went downstairs in the Boy's Club of Pittsburgh. Ch

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

Examples of combination products may in

ck introduced me to the guys in the basement. They seemed friendly enough. The atmosphere was exciting, despite the lack luster of the weight room. The room reeked of sweat and

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

metal. There was only one small vent window with and exhaust fan in it for circulating the air. But the guys down there were lifting much weight, and many were more muscular th

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

n anyone I had seen in real life.

That evening, Chuck put me through a 3 hour workout, the same one he was doing, and I actually did it. The next day, I could hardly walk, and

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

Combination pro

It felt like there was a bowling ball in my stomach. But, I was hooked.

Over the next year or so, I lost about 20 pounds of fat. I became rather muscular with a V-shaped bodyb

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

ilder torso and legs.

From my first workout there, I also became an observer. First I observed myself. Adding muscle took a lot of work and time, along with a healthy diet loa

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

ed with protein. Over time, I watched guys add pounds of muscle on their bodies, in what seemed a matter of weeks. Powerlifters and olympic style lifters were gaining 30 to 50

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

ounds in their lifts in a short time period. This was amazing to me.

One night, in the locker room, a bodybuilder told me I had on stage potential. I, replied that I never rea

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

ly gave it any thought. He said I should,and let me in on a secret. The I was offered some little blue pills. It turns out these little blue were Diannabol. Diannabol is an ana

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

olic steroid. Yeas I believe, these were the beginnings of steroid abuse. I declined the little blue pills. Once I found out what they were, I started reading everything I coul

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

Following aspects would a

find on the subject. I mean, it obviously worked, but it did not seem natural or right.

At that time, around 1968, there was not a whole lot of literature on the subject. 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 was there, was pretty scary though. These guys were popping 5 to 10 of these at a time. And who knows how many times a day? When they could get their hands on injectable test

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

sterone, they would add this to their regimen.

One day, I brought in an article on the side effects of anabolic steroid abuse. I pinned it on the bulletin board. Many guys rea

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

it. After working out and showering, I went back to say god-bye to the guys remaining there. The article was ripped up in little bits on th floor below the bulletin board. Per

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

aps, it was steroid rage.

Anyway, anabolic steroid have therapeutic use in health care. And it does add lean muscle mass. They can be a good thing if used under medical superv

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

Professional from academic institutions, pharmaceutical industries, health care indust

sion.

Long term abuse is not good. It has many side effects. What makes matters worse, there side effects are irreversible. These include , but are not limited to baldness, re

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

uced sperm count, infertility, actual shrinking of the testicles ( Jose Canseco" ex-wife said his testicles were the size of peanuts ), development of breasts, increased chance

.

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

of prostate cancer, skeletal damage ( especially in youth ), liver damage ( including hepatitis ), paranoia, aggressive behavior, and impaired judgment due to a sense of invinc

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

Companies that provide selfless information through particip

bility. And being a hormone, it has a straining effect on the other hormonal systems in the body. It is not worth the fifteen minutes of fames you may get from using steroids

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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