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Summary - Omega-3 DHA Reduces Diastolic Blood Pressure
A report published in the April, 2007 issue of The Journal of Nutrition concluded that supp
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
lementing with a low dose of docosahexaenoic acid (DHA), an omega-3 polyunsaturated fatty a
; 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
id found in fish, krill, and the algae they feed on, lowers diastolic blood pressure in mid
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
dle-aged men and women.
Researchers at King's College in London, England randomized 20 men
Researchers at King's College in London, England randomized 20 men
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
and 18 women aged 40 to 65 to receive 0.7 grams DHA derived from algae or an olive oil plac
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ebo daily for three months. The treatment period was followed by a period of at least four
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
onths during which no supplement was given, succeeded by another three months during which
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
each group was given the supplement the other group had received in the initial treatment p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ase. Blood pressure was measured, and blood and urine samples were collected and tested at
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
the beginning and end of each treatment period.
Treatment with DHA resulted in a 58 percen
Treatment with DHA resulted in a 58 percen
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
increase in the DHA content of red blood cells, accompanied by a reduction in the unhealth
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
y ratio of omega-6 to omega-3 fatty acids. Diastolic blood pressure was lowered by an avera
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
e of 3.3. mm HG and heart rate was reduced by 2.1 beats per minute after DHA administration
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
compared to after the placebo period. Measures of arterial stiffness and endothelial funct
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
on did not change during the short periods of DHA administration.
"A significant reduction
"A significant reduction
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
in diastolic blood pressure was noted which is likely to be of clinical significance with
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
egard to risk of future vascular events in middle-aged subjects," the authors conclude. "Fu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ture work is needed to confirm these findings and to investigate further the effects of DHA
.
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
on cardiac function." Neptune krill oil is another important source of DHA and EPA omega-3
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
fatty acids with some studies demonstrating an effect 8 times that of omega-3 from fish oil
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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