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Advice Pool - Acupuncture and Treating Infertility
It may seem like fertility treatment is a by-product of our modern, technologically advanced world. The very frontiers of high-tech science are pushed by th
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
e challenges of fertility treatment: hormones injections and IVF. And as wonderful as the advances are in helping couples to achieve their dream, the succes
; 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
rate is far from perfect, leaving many turning back to much older technology – the ancient Chinese art of Acupuncture.
Acupuncture is gaining acceptance as
Acupuncture is gaining acceptance as
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
a complementary therapy to other fertility treatments, where it has proven to be especially beneficial. Studies have shown that acupuncture definitely incr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ases the rate of pregnancy in women undergoing in vitro fertilization (IVF).
A well-known German study done in 2002 followed 160 women who underwent IVF, 80
A well-known German study done in 2002 followed 160 women who underwent IVF, 80
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
of them received acupuncture as well and 34 of those women got pregnant: a success rate of 42.5%. Of the other 80 women, those who received IVF without any
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
acupuncture treatments, only 21 women (26.3%) became pregnant.
Another study, American, of 114 women showed that 51% of the women who had acupuncture and IV
Another study, American, of 114 women showed that 51% of the women who had acupuncture and IV
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
treatments became pregnant compared to 36% of women who had IVF alone. Further analysis of the data revealed a much lower rate of miscarriage for the women
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
who had acupuncture as well as IVF.
No one can agree on how or why this therapy works. The traditional Chinese practitioner’s explanation involves concepts
No one can agree on how or why this therapy works. The traditional Chinese practitioner’s explanation involves concepts
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
such as ‘Qi’, imbalance and a restoration of harmony to the body, but according to Western medicine, the explanation is more likely to lie in brain chemistr
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
.
However, a slightly more Western way of looking at the effects points less to the mystical Qi and more towards the solid science of brain chemistry. It h
However, a slightly more Western way of looking at the effects points less to the mystical Qi and more towards the solid science of brain chemistry. It h
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
s been noted that acupuncture increases production of endorphins, the body's natural "feel good" brain chemical that also plays a role in regulating the mens
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
trual cycle, egg production and possibly ovulation.
It has also been found that acupuncture treatment for infertility increases blood supply and flow to the
It has also been found that acupuncture treatment for infertility increases blood supply and flow to the
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
reproductive organs, leading to speculation about increased egg follicles and elevated hormone levels around the ovaries.
It is also possible that acupunctu
It is also possible that acupunctu
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
e could help when the lining of the uterus is too weak to maintain a pregnancy - a problem associated with miscarriage. Increased blood flow may lead to a s
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
tronger lining in the uterus better able to sustain an implanted embryo.
Unfortunately, acupuncture will not help everyone. Good candidates have functional
Unfortunately, acupuncture will not help everyone. Good candidates have functional
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
rather than structural reasons for infertility. Where there is a structural problem - such as a blocked fallopian tube or a fibroid tumour - acupuncture is
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ot likely to help. And, past a certain age, acupuncture has little chance of being effective.
If you are looking at acupuncture as a first or complementary
If you are looking at acupuncture as a first or complementary
.
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
treatment, make sure you find a respected practitioner, preferably one known to and in contact with your fertility doctor. Be aware that treatments can var
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
dramatically in length and method, as can the costs. And be sure to check that you are covered for acupuncture by examining your insurance policy carefully
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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