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The practice of baby gender selection is becoming a more popular one as couples decide to l

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

imit the number of children they have. Many couples feel that if they are only going to hav

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

Examples of combination products may in

e one child or two that it might as well be the sex they want it to be. There are medical e

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

thics with this choice but as more couples are prepared to put twenty thousand dollars out

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

to make this happen more clinics are offering this service.

Normally for every one thousan

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

Combination pro

girls who are born there are one thousand and fifty boys born. Yet, there are people who d

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

o not think that the hit and miss approach is satisfying enough and will be prepared to use

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

the medical methods open to them to have the son or daughter that they prefer. If the cho

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

ice is to medically make it happen it requires fertility treatments. Some clinics will only

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

perform this type of treatment if the couple is married and have a child that is not the s

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

x of the child the couple wants. Others will not put any rules on the reasons.

One medical

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

Following aspects would a

option is the preimplantation genetic diagnosis. In this situation the egg is fertilized i

dd to the challenges in developing combination products:

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

n a petri dish and tested at three to five days old to determine the sex of the embryos. Th

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

is system was originally developed to screen for genetic diseases but it has since been mod

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

ified to screen for the gender. This method comes as close to being one hundred percent ef

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

ective as is possible.

There are other methods that are less costly, and not as effective.

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

Professional from academic institutions, pharmaceutical industries, health care indust

There are kits that can be bought that will change the chemical balance of the couple to a

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

ssist them in conceiving an infant of the preferred sex. These are supposed to be ninety si

.

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

x percent reliable. Deciding on baby gender selection as the way to choose the sex of your

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

Companies that provide selfless information through particip

unborn is an emotional and financial commitment that many people are unsure is worth either

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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