Summary - Self Improvement

Crystal Meth, that is. More commonly referred to as ‘ice’ or ‘speed’ and closely connected with ecstasy or cocaine. If you are reading this, you may be curious and know

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

nothing about this drug or you may know as little as what you hear on the news and want to know more. You may be a concerned parent, grandparent, teacher, health offic

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

Examples of combination products may in

ial, business owner, coach, friend or a genuinely concerned citizen. Whatever the case may be, I strongly believe that ignorance is not bliss, so I chose to share a summ

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

ry of what I learned through my own concern and curiosity.

So what is Crystal “Meth”? This is the street name given for methamphetamine, which is in the amphetamines g

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

roup of drugs. It is a stimulant, which speeds the body’s central nervous system. The increase in popularity seems to come with the longer lasting highs in comparison t

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

Combination pro

other stimulants. It can be smoked or injected for an instant high, taken orally taking 30-60 minutes or snorted taking 2-5 minutes.

It basically tricks the body into

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

believing it has unlimited reserves. Some users experience side effects such as itching welts on the skin, nausea, vomiting, diarrhea high blood pressure, and uncontroll

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 body movements like a seizure. It is dangerous, and has devastating long-term consequences, ranging from violence, self-destructiveness, and possibly even brain damag

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

. It can produce hallucinations, delusions, and paranoia and homicidal/suicidal thoughts. The brain damage caused by “meth” is similar to the damage caused by stroke,

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

epilepsy or Alzheimer’s disease. Addiction can happen very innocently and accidentally, after one try but withdrawal is so severe, they keep using.

There seems to be no

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

correlation between gender, race, background or academic ability. The age for first time users seem to be between 12-14, but is not limited to the teen population. World

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

Following aspects would a

wide, it is second in line to marijuana, as the most commonly used illicit drug, with over 35 million users. Issues of major concern are that it is much cheaper than co

dd to the challenges in developing combination products:

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

caine to produce, the products needed are easily accessible and there already is history of substance abuse problems in this province. Saskatchewan has a lot of remote,

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

wide-open area, where labs can very easily be set up without chance of close scrutiny.

These illegal laboratories can be set up in a short time by simply shopping for t

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

he necessary toxic ingredients in local grocery, hardware, and drug stores. The hazardous materials used in these labs and the extreme heat needed to produce it create a

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

risk to anyone living in the area due to the risk of explosion or fire. Then the issue of clean up and disposal becomes a secondary concern

One could not begin to imagi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ne how a human body would be affected, nor would one ever imagine the frame of mind the person is in that is using. A recent conversation I had with a young man in his 2

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

0’s told me about a good friend of his who was using and how his appearance resembled that of a person with terminal cancer. He was addicted, unemployed and basically h

.

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

meless. Upon asking further questions, it was obvious to me that this drug is out there everywhere and it is a concern.

I believe awareness is the key and we truly do

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

Companies that provide selfless information through particip

owe it to ourselves to keep informed for the sake of our loved ones, our communities and the people who risk their lives every day to make our world a safe place to live

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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