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The Dominican Republic is the second largest country in the Carribbean regi

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

on of the world. The Dominican Republic lies to the east of the Caribbean I

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

Examples of combination products may in

slands and is bounded by the Atlantic Ocean in the north and the Caribbean

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

ea in the south. The Dominican Republic enjoys a representative democracy s

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

imilar to that in the U.S. The history of the republic dates back to over 5

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

Combination pro

000 years. Christopher Columbus explored it in 1492. He named the new colon

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

y, La Espa?ola. Taino Indians were the inhabitants of the island at that ti

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

e. The capital city of Santo Domingo was founded in 1496. History saw the S

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

panish ruling the country in the era preceding 1795. The French took over t

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

at year. The French lost their possessions to the Haitians who ruled it fro

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

m 1804 to 1808. Spain gained control of the colony and ruled it until 1821.

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

Following aspects would a

The country fell to the Haitians again in 1822, and they ruled until 1844.

dd to the challenges in developing combination products:

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

The Spanish empire again took possession of the country from 1861 to1865.

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

The United States occupied the country between 1916 and 1924. From 1930 to

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

961, a military dictator by name Rafael Le?nidas Trujillo Molina ruled the

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

country. Joaqu?n Balaguer, the leader of PRSC (Partido Reformista Social Cr

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

Professional from academic institutions, pharmaceutical industries, health care indust

stiano), was the president of the country from 1966 to 1978. The country be

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

came stable in his regime. He was defeated by Salvador Jorge Blanco of the

.

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

ominican Revolutionary Party in 1982. He was re-elected in 1990. Since 1996

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

Companies that provide selfless information through particip

, competitive presidential elections have been conducted on a regular basis

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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