I Suggest - Food and Drink

History:

The origins of artichokes date back to the time of the Greek philosopher and naturalist Theophrastus (371-287 B.C.), who wrote about their growth in Italy and Sicily. A

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

ncient Greeks and Romans considered artichokes an aphrodisiac and in Greece they were also thought to be effective in securing the birth of boys. In the 1800s, French immigrants brought

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

Examples of combination products may in

artichokes to the United States when they settled in the Louisiana Territory. In the latter part of the 1800s, French colonists established artichokes in the Monterey area of Californi

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. California is now the world’s largest producer of artichokes. In the 1920s, Ciro Terranova “Whitey”, a member of the mafia known as the “Artichoke King,” began his monopoly of the ar

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

tichoke market by purchasing all the produce shipped to New York from California for $6 a crate. He created a produce company and sold the artichokes at a 30-40% profit. This later led

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

Combination pro

to “the artichoke wars” and the mayor of New York at the time, Fiorello La Guardia banned the sale, display and possession of artichokes. The ban was lifted after only one week when the

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

mayor admitted that he himself loved the vegetable.

Nutrition:

Artichokes contain the chemical, cynarin, which researchers are finding benefits the liver. Silymarin is another

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

compound found in artichokes that has powerful anti-oxidant properties. A medium artichoke has 25 calories and provides phosphorus, magnesium, manganese, chromium, potassium, iron and

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

calcium. They are also a good source of fiber, vitamin C, and folate. They are low in sodium and have no fat or cholesterol. They can help reduce the risk of many kinds of heart disease

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

, cancer and birth defects.

Artichoke Trivia:

• Artichokes are a member of the flowering thistle family.
• In 1949, Marilyn Monroe was crowned the Artichoke Queen of Calif

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

ornia.
• The word artichoke was taken from the Italian word “articiocco” which means pinecone.
• The Roman goddess Cynara, was said to have been turned into an artichoke for a

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

Following aspects would a

ll eternity by Jupiter.
• The artichoke was once considered to be an aphrodisiac.
• 99% of commercially grown artichokes are cultivated in California.
• Each year an arti

dd to the challenges in developing combination products:

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

choke festival is held in Castroville, California.
• Artichokes are great treats for the diabetic diet, due to their low calories, low carbohydrates and high fiber.
• Artichok

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

es are thought to be one of the rare foods for which there is no proper wine pairing because they impart a sweetness to anything that follows them.

Recipe:

Artichoke Sou

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

p

Serving Size: 10

INGREDIENTS:

• 20 fresh artichokes
• 2 tablespoons kosher salt
• 3 sliced lemons
• 2 oz. olive oil
• ? cup diced celery
• ? cup

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

diced leeks
• 1 cup diced white onions
• ? cup diced shallots
• 1 tablespoon minced garlic
• 1 bay leaf
• 1 quart vegetable stock
• 5 ounces sliced truffl

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

Professional from academic institutions, pharmaceutical industries, health care indust

es
• opal basil oil
• salt and pepper to taste

Simmer the artichokes in salted lemon water until tender. Remove them from the water and cool in an ice bath. Peel away the lea

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

ves. Remove the hearts and bottoms and dice them.

In a soup pot, heat the olive oil and add the celery, leeks, onions, shallots and garlic and saut? until tender.

Add the diced artich

.

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

okes, bay leaf and stock and simmer for approximately 45 minutes.

Remove from the heat, remove the bay leaf, puree the soup in a blender and strain through a strainer.

Adjust the seas

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

Companies that provide selfless information through particip

onings with salt and pepper and adjust the consistency with additional stock if necessary.

Pour the soup into hot soup bowls. Garnish with sliced truffles and opal basil oil and serve.

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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