Advice Pool - Health and Fitness

A friend of mine was diagnosed to be mildly diabetic and prescribed some medication. This was the result of his recent annual checkup

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

when he found out that his BMI (body mass index) and fasting glucose levels were high.

But he is a type of person that is resistanc

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

Examples of combination products may in

to medication. So, he did some research and came across some B-complex supplements that claim to convert glucose to energy. He was n

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

ot sure whether this may replace the medication he is supposed to take. He, therefore, seeks help from a microbiologist whose advice

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

s as follow.

It is important to get enough B vitamins to balance sugar levels but relying solely on B-complex supplement alone will

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

Combination pro

ot solve the problem. Medication should be taken but meanwhile one should also adjust different aspect of his lifestyle.

Physical ac

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

tivity can keep sugar levels balanced, and losing weight can make a big difference in successfully managing diabetes. Diet does play

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

role, too. One should learn about GI (glycemic index) of foods and choose foods that are low on that scale. These foods will be abso

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

bed slowly and will not stress the body with sudden sugar extremes.

Apply principles of eating well. Boost intake of whole foods, wh

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

ich will smooth out any deficiencies the body might have. One may also start taking multi-vitamin. Here are some guidelines:

- Feast

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

on vegetables;

- Add whole cereals, cold pressed olive oil, lean protein like fish, and snack on nuts, seeds, and low-sugar fruit.

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

Following aspects would a

Keep red meat, butter, fast food and anything sugary to a minimum.

This may be difficult to follow but it is a matter of changing h

dd to the challenges in developing combination products:

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

abits.

Besides the abovementioned fundamental changes, there are a few other options:

- Boost intake of antioxidants by taking extr

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

vitamin C (500 mg to 1000 mg) and a vitamin E supplement that is rich in tocotrienols.

- Fish oils protect the heart and arteries,

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

hich become more vulnerable with diabetes. Take 1000 mg of omega-3 fatty acids.

- Ayurvedic herb Gymnema can help too.

When moving

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

from pills to plate, start with the easiest:

- Cinnamon helps lower sugar. Even half a teaspoon of cinnamon taken every day lowers b

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

Professional from academic institutions, pharmaceutical industries, health care indust

ood sugar.

- Bitter melon, well established in Indian and Chinese medicine, has been shown to be as powerful as a commonly used diab

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

tic drug. Take its juice regularly.

- Funugreek is also beneficial. The seeds can be ground into a powder or soaked and eaten whole.

.

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

Start small, with a teaspoon, and increase as required.

Do not take all that are recommended. One or two that can suit the body sho

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

Companies that provide selfless information through particip

ld be good enough. Make changes conservatively and gradually. Last but not lease, ensure to monitor regularly the blood glucose level

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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