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“Appurate!” My grandmother yelled from the car. “Hurry up!” My mother, yelled, as though attempting to drown her out. My mother and g

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

randmother were at war with one another when it came to language. My mother, who emigrated from Mexico when she was sixteen and worke

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

Examples of combination products may in

d hard to overcome the language barrier, was convinced that Spanish would be nothing but a hindrance to us; a stigma. She still spoke

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

Spanish to her sisters, but she always made a point to address us children in English. My grandmother ignored this mandate, and spok

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

e (or more frequently yelled) strictly in Spanish. When we spoke English she stubbornly pretended she couldn’t understand us, though

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

Combination pro

my mother pointed out that never seemed to have any problem following the plots or plays on words when watching her favorite TV shows

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

. Though this battle between my mother and grandmother raged for years, in the end my grandmother won out. As it happens, so did I.

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

At first I didn’t see Spanish as an advantage. Spanish was a way to safely gossip while waiting in line at the grocery store; Spanish

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

was a way for me and my cousin to trade secrets at school. Cursing was more satisfying in Spanish, love songs more mournful. But unt

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

il the internet boomed, Spanish was a private comfort, not a marketable asset. All that has changed.

With the US census bureau proje

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

ting a 188% increase in our Hispanic population over the course of the next 50 years, corporations are scrabbling to catch up and mee

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

Following aspects would a

t the needs of an increasingly bilingual populace. Today, sites like LatPRo and bilingualcareer.com rival Monster.com as job search a

dd to the challenges in developing combination products:

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

nd hiring resources. These sites offer corporations a way to meet their growing need for industry specific bilingual professionals; t

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

hey offer me a way to pursue a professional career from home. Despite these innovations I noticed that many childhood friends weren

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

’t utilizing their bilingual advantage. Some worked at minimum wage customer service jobs when they could have been making considerab

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

ly more money in a similar bilingual position. Others were professionals who were still making less money than they would have had th

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

Professional from academic institutions, pharmaceutical industries, health care indust

ey been utilizing their bilingual skills. Because they, like myself, were raised to think of their native language as a liability, th

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

ey had never realized that it was now a marketable asset. After I introduced one friend to my favorite web-based job finders (bilingu

.

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

alcareer.com, LatPro, etc.), she is able to work half time and make the same amount she was making at her previous (non-bilingual) jo

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

Companies that provide selfless information through particip

b. As a translator, I am able to work from home and spend plenty of time with my kids. Which ensures that, yes, they do speak Spanish

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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