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Low carb eating has been a fixture now for a number of years and, for many people it creates a vision of deprivation and possible ill health. After all, some seemingly essential foods are ‘cut out’ by anyone who follows this diet and this, in itself,

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

seems less than healthy.

Actually, this is very far from the truth. Low carb diets, personified by the Atkins Diet, the South Beach diet, the Protein Power diet and the Sugar Busters diet, do actually contain some carbohydrates, or carbs for short,

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

Examples of combination products may in

especially in the maintenance phases.

What is a low carb diet? The best way I can explain this is to look at the Atkins diet, a diet which is approached in 4 phases.

Before explaining what happens in each of the 4 phases, I will detail what foods

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

can be eaten in the diet. Actually, there is quite a lot of choices, the main restriction being the amount of carbs that are eaten.

All fish, fowl, shellfish, meat and eggs are permitted but no cured meat like ham is allowed. Anyone following the di

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

et needs to avoid any meat with additives in it such as meatloaf and breaded food. Oysters and mussels are also higher in carb so only 4 ounces of these are allowed per day.

Four ounces of the following cheeses are allowed each day:

cheddar
co

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

Combination pro

w, sheep and goat cheese
cream cheese
gouda
mozzarella
roquefort and other blue cheeses
swiss cheese

The following vegetables are the only ones permitted in the first 2 weeks:

daikon
mushrooms
arugual
endive

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

r> parsley
bok choy
escarole
peppers
celery
fennel
radicchio
chicory
jicama
radishes
chives
lettuce

cucumber
mache
sorrel

Other vegetables are higher in carbs but can be used,

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

after the first two weeks, to add variety:

Artichoke
Pumpkin
Artichoke hearts
Rhubarb
Asparagus
Chard
Sauerkraut
Bamboo shoots
Collard greens
Scallions
Dandelion
Snow peas
Bean sprouts

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

Dandelion greens
Beet greens
Eggplant
Spinach
Broccoli
String or wax beans
Kale
Summer squash
Tomato
Leeks
Turnips
Cabbage
Water chestnuts
Cauliflower
Onion
Zucchini

The At

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

kins diet, in every phase, should be tailored to your own individual preferences and most of the meals should comprise whole foods. You should:

avoid any trigger foods such as bread and sweet items
eat either 3 regular meals or 4 to 5 smaller m

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

eals
have liberal amounts of fat and protein
have no more than 12-15 grams of carbs in the form of the permitted vegetables
have no fruit, pasta, grains, starchy vegetables or dairy products except for cheese, cream or butter
have

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

Following aspects would a

no nuts or seeds in the first 2 weeks; chickpeas, kidney beans and other legumes are also not permitted in phase one
not eat anything not on the acceptable foods list
adjust the quantity to your appetite
not assume anything is low carb

dd to the challenges in developing combination products:

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

– always read the labels
use sucralose or saccharin as a sweetener
drink at least ten 8 ounce glasses of water
take a good multivitamin with minerals such as potassium, magnesium and calcium but not iron

The induction phase, or phase o

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

ne, kick starts the body switching its metabolism to one that primarily burns fat for energy instead of burning carbs. It:

stabilizes blood sugar
curbs cravings since it breaks the addictions to sugar, wheat/corn derivatives, alcohol, caffeine,

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

grain or any other food
allows you to experience the metabolic advantage of the diet
shows how much fat your body can burn

The induction phase is not a life long plan. It does, however, allow for snacks should a craving arise between meal

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

s. Snacks can be cheese sticks, nuts, low carb instant soup, crisp breads, low carb soy chips and celery sticks stuffed with cream cheese or peanut butter.

Phase two is about ongoing weight loss. It:

has expanded food options
allows 25 grams

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

Professional from academic institutions, pharmaceutical industries, health care indust

of carbs per day
gives the option of mixing and matching to suit the person
gradually increases the daily carb tally in 5 gram increments until the weight loss slows
still has counting carbs as the key to successful management
ensu

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

res a person stays with phase 2 until only 10 lb is left to lose

Phase three is a continuation of phase 2. More grams of carbs are added until you are losing less than one pound per week. Continue with this phase until goal weight is reached and yo

.

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

u keep this weight for one month.

Once this happens, you are on the lifetime maintenance phase. You need to focus on the ACE (Atkins Carbohydrate Equilibrium) and always try to stay within 5 lbs of your goal weight.

The Atkins diet, and other low

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

Companies that provide selfless information through particip

carb diets, guarantee weight loss and there are testimonials to this effect. The diet is not difficult but, at the beginning it can be restrictive. At the end, after goal weight is reached and maintained, some fruit can be eaten as part of the diet

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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