Useful Articles - Health and Fitness

If you have a significant amount of weight to lose – say 20 pounds or more – the task ahead of you can seem very daunting. Is it any wonder that so many people try to put it off, or to de

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

ny that the problem is as serious as it really is? But studies show that being significantly overweight carries with it a huge health risk, so being in denial about weight problems is ver

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

Examples of combination products may in

dangerous – it can even be deadly.

Still, when you think about it in terms of a concrete plan to lose weight, it can be very daunting indeed. One pound is approximately 3,500 calories,

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

nd just thinking about how much exercise you would have to do to burn that much is exhausting. You can understand why people put it off, even though that has the potential of making the p

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

oblem worse.

Maybe the best advice, therefore, is this: Take it slow. Don’t try to lose the weight all at once, especially if you have a lot of weight to lose. Instead, every week, commi

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

Combination pro

t to a small change in your lifestyle that takes you a little bit closer to your goal. For example, the first week you might decide to add some exercise to your daily regime. But if you d

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

n’t have the time or the energy to go to the gym and do a full scale work out, don’t worry about it – you can still participate. Commit to going for a fifteen minute walk every day after

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

inner – just fifteen minutes, just an easy walk, but you have to do it every day, rain or shine. It doesn’t sound like an ambitious plan – almost anyone can do it. The point is actually d

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

ing it, not just thinking about it.

The next week, you might decide to address the health of your diet, so you decide to eat fruit for a snack instead of the crackers or chips you might

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

normally reach for. Again, it’s a small thing, just one modified snack a day. But again, if you do it everyday, soon it will start to make a difference.

Here’s the trick, though. When yo

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

start implementing your second week’s change, keep doing what you committed to doing the first week. I mean, you might as well. You’re already used to it, and each of these changes, in a

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

Following aspects would a

d of themselves, are small and easy. So during the second week, you’re walking every day and eating fruit. You’re well on your way. The third week, you may decide to eat a bit less. Here’

dd to the challenges in developing combination products:

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

an easy way to do it – for any food that you would normally eat, take away a quarter of it. So, fill your plate and then take off a quarter of the food and put it in a Tupperware contain

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

er for later, or buy a slice of pizza at lunch but tear off a quarter. Throw it away, or, if that offends your moral sense, put it out for the homeless. Or get a doggie bag, if you’re in

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

restaurant. Of course, if there’s an actual dog around, you can feed it your excess food. Then proceed to enjoy the rest of the meal or snack, regardless of what it is. Fruits and vegeta

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

les are exempt from this process, by the way – they don’t need to be ‘quartered’.

It is usually at this point, around the three-week mark, that people start noticing a difference in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ay their clothes fit. Weight loss is starting to kick in, and it will only accelerate during the coming weeks. We don’t recommend that you weigh yourself, however. Save that for the end,

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

and you’ll be amazed. In the meantime, enjoy how different your lifestyle changes are making you look and feel. Keep accumulating them.

Here are some more ideas for incremental changes:

.

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

uring the fourth week, you might want to give up fried foods, if they are something you normally eat. Or you might want to walk instead of taking the elevator, or park three blocks away f

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

Companies that provide selfless information through particip

om home or the office and walk the remainder. The point is that it all adds up. You don’t need to make big changes in your lifestyle – over time, the little ones an make a huge difference

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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