Advice Pool - Health and Fitness

Just last week I had an unexpected surprise that turned my world upside down. Had I known the signs of a Type 1 diabetes, my 7 year old would have been given the proper care at the early stages of her Type one diabetes.

Both my husband and I do n

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

ot have anyone in our family with a history of diabetes nor did we know much about diabetes. Just last week our seven year old daughter was admitted into the Pediatrics Intensive Care Unit after she was diagnose with Type 1 diabetes.

Just a bit ov

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

Examples of combination products may in

er a month ago our daughter seemed to be a healthy seven year old started losing weight. We noticed she started looking thin like her older sister was at her age. This seven year old has always been an average size kid but was not thin. So as pa

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

ents, we assumed that she was going through a growth spirt. We did not think much about it. Then she seemed to be thirty, drinking more water than usual. Her skin seemed very dry. The air in Idaho is very dry and since it's winter we figured it

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

was the dry air and the season that cause the dryness on her skin. Two weeks ago she started experiencing low energy. She told us she did not feel good and so we kept her from school for a couple of days.

She did not have a fever so we were no

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

Combination pro

too concern. She was drinking a lot of water and thought that was a good thing. We knew the importance water intake for hydration and cleansing. What we were not aware of was how often she was going to the bathroom. So by Wednesday (3rd day)

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

we sent her to school since she seemed better and it was only a half day. She went to school Thursday and Friday. By the time she came back from school Friday, she was back to her very "low energy" and it progressed into the weekend. She felt a

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

bit nausea and her appetite was low which is normal when someone does not feel good. By Sunday evening she became so weak she could not even walk to the bathroom without someone supporting her. We figured we would take her to the doctors first th

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

ng in the morning, since she was not running a fever and thought that she was weakened from not eating much the past few days.

I did not realized how frequent she had to go to the bathroom until I had to help to the bathroom. It was every few minu

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

tes! By about three in the morning she complained about difficulty in breathing. That was when I realized this was not a normal "bug" she got and took her to the emergency. From there she was diagnose with Type 1 diabetes. Even though she was

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

rinking a lot of water she was extremely dehydrated, her glucose level was extremely high and blood pH was also very acidic. She was admitted into the Pediatric Intensive Care Unit.

I'd never learned so much and so fast about Type 1 diabetes than

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

Following aspects would a

those few days in the hospital with our daughter. My daughter is back to school today. So much has changed. She got home from the hospital Thursday and by Friday she can check her glucose and give herself insulin shots. She has learned what she

dd to the challenges in developing combination products:

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

can eat and when she can eat. At two every morning I wake her up to check her glucose level. She has to have insulin shorts the rest of her life. She is adjusting very well and so are we. We are just grateful for the modern technology and suppo

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

ts we received since this very unexpected surprise.

So what is Type 1 Diabetes?

Type 1 Diabetes is a condition when the body no longer produces insulin. Insulin acts like a key to unlock the cells in our body so the glucose can get into our cell

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

s to make energy. When insulin is not present, the cells in our body is all "locked" up. The glucose in our body get build up in our blood. The antibodies in the body for some reason thinks the cells (icelet) in the pancreas which produce insuli

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

, are foreign bodies so they kill them off (autoimmunity). Now these cells no longer produce insulin. Because sugar cannot be used for energy, the body breaks down fat for energy. Keytones are the results of using fat for energy.

Type 1 diabete

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

Professional from academic institutions, pharmaceutical industries, health care indust

s is a childhood, juvenile, Insulin-dependent condition for life. The most common signs are frequent passing of urine, constant thirst and weight loss.

Here are the symptoms of Type 1 diabetes:

For Hyperglycemia (high blood glucose)

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

treme Thirst

Frequent Urination

Dry skin

Hunger

Blurred vision

Drowsiness

Nausea

For Hypoglycemia (Low Blood Glucose)

Shaking
Fast Heart beat
Sweating
Anxious
Dizziness
Hu

.

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

ger

Impaired Vision

Weakness Fatigue

Headache

Irritable

I feel the urgency to educate others to be aware of these symptoms of Type 1 diabetes. It's a very common condition suffered by many children and young adults.

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

Companies that provide selfless information through particip

Just because you do not have a family history of diabetes, does not mean no one in your family will ever gets it, as I have learned just a week ago. When we are armed with correct information, we can bless the lives of others as well as ourselves

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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No, it’s not a general question for all and sundry. Obviously, there are many who would want to link to a Home Business or Affiliate program related website and for good reason. They would be helping their Page Rank, if that’s important any more however, more to the point, they would be improving their chances of a better ranking in the SERPs (Search Engine Results Pages). But yes, you guessed it, THERE IS A PROVISO. A very important one, that so many people engaged in reciprocal linking programs just don’t seem to be able to get their heads around…

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