Your Space - Health and Fitness

If you have, or do, suffer from depression you will relate to the common response from friends, family and colleagues "Oh! get over it", or "It's all in your mind". How wrong they are! How terrifying is it when you see a loved one or friend heading on the downward path and no matter what you

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

say or do, how much you care it doesn't seem to make a difference to them trying to destroy themselves. That is, if you even recognise they have a problem! Because sometimes you don't see, or can't recognise, some changes however slight that can contribute to the demise of your loved one and

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

Examples of combination products may in

are shocked to the core at their "sudden" problem or even death.

It's true it's possible to tell from a person's voice over the phone what their mood is - particularly if you know that person. How many times have you heard "smile when you answer the phone" - people can tell you are happy or c

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

ontented through that unseen smile. It takes a massive effort to conjure up a smile when seriously depressed and at some stage we forget to "produce" that smile; this could be a trigger to listen more closely to your friends/loved one's tone of voice and become aware of when they might be "do

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 in the dumps", showing no interest in doing anything or excessively sleeping.

Just been there with a close member of my family (let's call him "Mat"). After enduring work problems, a relationship breakup and consequently very nasty verbal exchanges all falling on him at once, Mat hit the di

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

Combination pro

rt. He could see no reason to keep going; he felt he was not worthy. His mind was a turmoil of conflicting emotions, with the demons seemingly winning.

We'd been through something similar to this before in his younger days ... when (thankfully) he allowed us into his inner thoughts, fears an

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

d feelings so we were able to listen to his negatives and try to provide a positive. We sought the advice of a Psychiatrist then, and found through his various tests, a chemical imbalance in his body and other contributing factors. With the help of some medication we got through that and assu

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 life was on again as normal . But that medication was strong and had some awful side effects; foods that couldn't be eaten or they would push the blood pressure up so high it could cause death, so he had to be totally aware of what was in all foods and avoid those "mature" things, eg blue

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

vein cheese and avocado. Then there were the tremors - terrible shaking not only in body but in mind. With an adjustment to medication, life for him became OK again.

Till now! His contentment has again been destroyed and his life been hell on earth. The demons came back, the turmoil starte

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

d again, his workmates were unsupportive and uncaring, he was running out of money. His will to work flew out the window and so did his will to live. But he struggled on with the love and support of some close friends and his parents - but the conflicting emotions and thoughts constantly bo

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

barded his mind until he could stand it no longer. The hopelessness of living with this every day and night was just too much. He made the decision, after indepth discussions with his psychiatrist and knowing the risks, to have ECT (electroconvulsive therapy) or shock treatment.

First two t

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

Following aspects would a

reatment were relatively mild with no reaction; but sitting in a small recovery room with other patients ranging from young to older men and women who were also having similar treatment, was like being in a room full of zombies. One could only hope that they received benefit from the trauma th

dd to the challenges in developing combination products:

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

ey'd been through. At the third treatment Mat felt absolutely fantastic! But, three treatments, said the Psychiatrist, is not enough for long term benefit - he would need six. And we couldn't know at that time what hell was to follow. At the fourth treatment Mat was one of the zombie-like pa

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

tients. Crying, confused in the head, couldn't make a simple decision, didn't know where he was and where he was supposed to be going. He couldn't be left on his own because we didn't know what he might do next. The headaches were unbearable and the conflicting thoughts positive and negative

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

ept fighting inside his head. At the fifth treatment nothing changed the way he felt, except that he (Matt) made the decision that five treatments was enough - he couldn't go through any more.

For 5 days after that final treatment Matt was out of this world with fear, pain, anger - you name i

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

t he had it. During one particularly bad day he phoned us and said nothing's changing, he couldn't go on, his supportive friends could not help him any more. Frightened of what he might do next, we rushed over to him and in a great moment of "sanity" he knew he had to go back to his Psychiatr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ist. We went immediately to the comfort and security of his Psychiatrist's rooms where he would see us quickly. This Doctor was amazing - so many times he'd seen this before; he understood what was happening and immediately gave Matt one dose of a "wafer" medication that, in less than an hour,

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

Matt had a clarity of mind and a calmness that he hadn't had before. It was incredible to just watch this change come over him so quickly after so many days of demons.

Armed with a week's supply of these "wafers", and an order to stay with family who would be with him for at least the next 15

.

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

days, Matt began to reap the benefits of the ECT. Slowly the mind cleared albiet with some loss of short term memory but this young man now has a future. There are still some days where he mightn't sleep, or may sleep but wake up a bit down, but with periodic checkups at the Psychiatrist's a

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

Companies that provide selfless information through particip

nd some gentle medication from time to time, the laughter, happiness and some direction is returning to his life. We feel confident the ECT has worked but only time will tell. At least he is now making his plans, setting his goals and dreaming of what he's going to achieve. That's a good sign

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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How do you know when you are assaulted? What exactly defines an assault situation? When do you switch from being safety cognizant and careful to being defensive and bringing the stun gun or defense pepper spray out?

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