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Eating oily fish is a great way to add Omega-3 Essential Fatty Acids to our diets and seaf

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

ood provides good variety as well as being one of the richest sources of this health boost

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

Examples of combination products may in

ing nutrient.

Made with fresh pasta and a generous portion of garlic this dish is a healt

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

hy and tasty recipe which can be eaten at any time.

To serve 4 people you will need;

2 c

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

loves of garlic, crushed

2cm (1in) fresh ginger, grated

1 bunch of spring onions, choppe

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

Combination pro

d

1 tbsp of extra virgin olive oil

3 tbsp of white wine or stock

350g (12oz) of mixed s

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

eafood, such as shrimps, clams, squid

2 tbsp of chopped fresh herbs, such as dill, corian

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

der, parsley

4 tbsp of low-calorie dressing or low-calorie mayonnaise

275g (10oz) of fre

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

sh pasta, for example linguine or tagliatelle

1 lemon or lime

Look out for organic or "f

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

ree range" seafood and if in doubt ask your fishmonger or supermarket for advice. Much of

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

the seafood available in supermarkets and fish shops, have been reared in hatcheries and f

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

Following aspects would a

arms where they are fed soya meals or grains which contain little or none of the Omega-3 E

dd to the challenges in developing combination products:

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

ssential Fatty Acids that plankton contains. As a result the quality of the fish oils are

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

not as high as "free range" fish.

We know this recipe is going to be good for us so lets

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

get cooking!

Saut? the garlic, ginger and spring onions in the olive oil for 2 to 3 minut

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

es until it has softened. Add the white wine or stock and allow to simmer for 2 minutes be

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

Professional from academic institutions, pharmaceutical industries, health care indust

fore adding the seafood.

Cook for a further 2 minutes to ensure the seafood is fully heat

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

ed through. Remove from the heat and stir in both the herbs and low-calorie dressing or lo

.

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

w-calorie mayonnaise.

Meanwhile, cook the pasta and ensure it is well drained before serv

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

Companies that provide selfless information through particip

ing.

Serve the pasta topped with the seafood and garnished with the lemon or lime wedges.

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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