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According to recently conducted experiments, cannabis can be considered an effective remedy for patients diagnosed with multiple sclerosis. While at first the sy

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

mptomatic improvements experienced by patients with multiple sclerosis who have been administered cannabinoid products were thought to be determined solely by ps

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

Examples of combination products may in

ychological factors, later research has revealed that cannabis actually reduces muscular spasms and stiffness characteristic to multiple sclerosis sufferers. The

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

benefic effects of cannabis on patients with multiple sclerosis have been confirmed by short-term and long-term controlled medical studies.

In 2003, a team of

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

researchers from the Peninsula Medical School in Exeter, UK have made public the results of a series of short-term and long-term studies on the effects of cannab

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

Combination pro

inoids among patients with multiple sclerosis. The previously conducted studies involved the active participation of around 600 patients with advanced-stage mult

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

iple sclerosis. The participants were divided in two distinctive groups: the first group received cannabinoid compounds in equal doses, while the second group re

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

ceived placebo medications over a period of 15 weeks. By the end of the experiment, the majority of patients who were administered cannabinoids experienced consi

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

derable symptomatic improvements, having less muscular pain and being confronted with milder muscular spasticity (less pronounced muscular spasm). Unlike the gro

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

up that received cannabinoid compounds over the entire period of the study, the control group (patients who received placebo medications) experienced no improvem

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

nts in their overall condition.

In order to confirm the relevancy of the findings and to discard any doubts concerning the efficiency of cannabis in amelioratin

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

Following aspects would a

g the symptoms of multiple sclerosis, the study was later repeated. The ulterior study was performed over a period of 12 months, and involved the participation o

dd to the challenges in developing combination products:

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

f the same subjects. However, this time the participants were divided into 3 distinctive groups instead of 2 as in the case of the previous experiment. The first

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

group received pills of D9-tetrahydrocannabinol (THC) – the active component in cannabis, the second group received natural cannabis extracts, while the third g

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

roup received placebo medications.

At the end of the experiment, patients were carefully evaluated and examined by a team of physiotherapists and neurologists.

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

The best results were obtained among the patients belonging to the first study group, the majority of subjects who have received equal doses of THC experiencing

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

Professional from academic institutions, pharmaceutical industries, health care indust

considerable improvements in their symptoms. The patients in the second study group experienced slight improvements in their symptoms, while the patients in the

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

third group felt no changes in their condition.

Despite the fact these studies clearly suggest that cannabis is an efficient remedy for multiple sclerosis, medi

.

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

cal scientists aren’t still convinced that cannabinoids can be successfully used in the treatment of multiple sclerosis. However, after performing additional stu

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

Companies that provide selfless information through particip

dies on the matter and more elaborate research, doctors may consider to introduce cannabinoid compounds in the treatment of multiple sclerosis in the near future

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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Pundits, Politicians, and average people remember the terrorist attacks on 9-11 but can anyone really explain the true lesson that must be learned? As a journalist, I struggled with this question.

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