Summary - Health and Fitness

With 65% of American’s clinically obese, it is not surprising to see multitudes on diets, trying to lose weight. There are however, some people who have struggled to put weight on. Typically, these people have a higher than average metabo

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

lism or expend a lot of calories in their day to day life. A few years ago I had a young lady in her early 20’s come into my office with a couple of health challenges. The first and most important was her low body weight. She had always

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

Examples of combination products may in

been thin but seemed to have lost even more weight after a bout with the flu and could not put it the weight back on. At 5”5’ she weighed in at well under 100 pounds. After visiting her doctor who told her to eat a lot of McDonald’s fast

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

ood to put on weight, she was recommended by a friend to my office. We went right to work and after some specific testing to locate causative factors to her weight problem I was able to determine a few key weaknesses.

Like so many America

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’s, this young lady suffered from tired adrenal glands which were interfering with her metabolism. As a result of the adrenal fatigue, her body was not able to produce normal digestive enzymes to help in the break down, absorption, and ut

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

Combination pro

lization of her food. This deficiency also contributed to her weak immune system and subsequent chronic infections. Once we started her on some specific nutrient formulas to help her adrenal glands, digestive system, as well as her immune

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

system, we saw a huge turn around. She no longer suffers from chronic colds and was able to break the 100 pound mark for the first time in her life in a relatively short period of time! I use this young lady as an example of some of us w

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

o can not seem to put on healthy muscle mass.

About a year ago I went through some major life changes. I actually moved 1,300 miles from the area I grew up in. I started a new business venture and was away from most of my family and frie

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

nds. This put a large amount of stress on me which started to take a toll on my physical body, as well as my mental health. During times of mental and physical stress your metabolism speeds up. I have always had a fast metabolism and if

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

am not working out regularly and eating calorie dense foods, that fast metabolism tends to lead to a catabolization of my muscle mass. I lost close to 15 pounds and was getting very frustrated. I want to share with you some tips I used t

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

o put on 17 pounds of muscle mass in just 60 days! If you are struggling to put on weight, especially muscle mass, then you will want to pay close attention to the following tips.

1) From the moment you are born your body begins to go thr

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

Following aspects would a

ough stress which affects your metabolism, so make sure you get on a good adrenal gland supplement to bring your adrenals and metabolism back to optimum function.

2) If you are not taking a digestive enzyme, you will NEVER make the muscle

dd to the challenges in developing combination products:

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

ass gains you are looking for. If you can’t break down the food, how do you expect to utilize the protein and other nutrients needed for building muscle?

3) You must eat small meals every 3 hours that you are awake. In order to keep your

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

metabolism from eating away at your muscle, or catabolising muscle to produce energy, you need to feed your metabolism enough calories. This is the most important part of the program!

4) Your diet should be 30% protein, 40% carbohydrate,

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

nd 30% non-hydrogenated fat.

5) You should eat a minimum of 0.8 grams of protein per pound of body weight.

6) Use a quality protein powder. It is often hard to take in the necessary amount of protein calories unless you are adding protei

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

n powder to your diet. There are only a few good whey protein powders on the market that are not overly heat processed, which destroys their biochemical integrity.

7) Eat a high protein meal as soon as you wake up. During sleep, your cor

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

Professional from academic institutions, pharmaceutical industries, health care indust

isol level raises which causes muscle catabolism. Protein will stop that catabolism!

8) Eat a protein at every meal. Protein intake will also ensure low insulin levels during the day and help avoid the storage of fat.

9) You can not bui

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

ld muscle if you are not pushing the muscles you have! In the gym, you should focus on heavy weights at low repetitions. Without breaking down muscle tissue through weight training, it will not be rebuilt with more mass.

10) Rest! Phys

.

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 and mental stress need to be kept to a minimum. Your muscles can not grow if you don’t rest them after work outs. Make sure you never work the same muscle group 2 days in a row and always try to get 8 hours of sleep. Remember, it is t

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

Companies that provide selfless information through particip

he recovery time that allows the muscle to grow.

These tips will help you achieve your muscle gaining goals, but it will take dedication and hard work! Until next time, keep seeking and applying the truth!

In health,

Thomas Von Ohlen, M

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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