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I Advice - How Safe Are Low Carb Diets?
Low carb diets have become popular due to the fact that they help reduce weight within a shor
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
t period. Many dieticians advocate reduction in the intake of carbohydrates in order to reduc
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
e body weight. Though low carb diets are widely followed, the safety and the efficacy in 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.
long term have not been medically established.
It has been observed that dieticians and medi
It has been observed that dieticians and medi
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
cal practitioners have different views about the diet to be followed for losing weight. Some
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
medical physicians are of the opinion that since carbohydrates are a major source of energy,
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
when its intake is reduced, proteins and saturated fats can be taken as an alternative source
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
of energy. The usage of saturated fats, however, exposes the body to heart problems. To dige
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
st the excess proteins and fats, the kidney has to work harder which may cause kidney dysfunc
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
tions. Calcium deficiency due to poor carb intake can affect the bone and liver functions.
E
E
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ssential nutrients like vitamins and minerals are obtained from fruits and vegetables, which
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
are missing in a low carb diet. Consequently, an individual following a low carb diet can bec
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ome deficient in these.
Weight loss due to low carb diets is yo-yo dieting as people tend to
Weight loss due to low carb diets is yo-yo dieting as people tend to
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
fluctuate between weight loss and gain when on these diets. This can cause the skin to relax
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
and contract. Also, when a low carb diet is discontinued, an individual can quickly regain t
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
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
he weight. A professional dietician would always suggest a permanent solution for weight loss
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
that are not just quick fixes but are spread over a longer period to ensure long-term result
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s. It is always better to include an exercise regime along with a balanced diet. Low carb die
.
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
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
ts should be strictly followed in consultation with a doctor. Relying exclusively on the advi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ce of consultants in weight loss centers that advocate quick weight loss is generally unsafe.
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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