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Useful Articles - What You Should Know About Mixing Medications and Diet...
I had a call the other day from a potential client in a serious situation. He was young and had been diagnosed with CAD (Coronary Artery Disease), suffering from extremely high blood pressure and cholesterol, his doctor had put him on
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
a medication that was suppose to lower and control these symptoms, and he had been on this medication for over 2 years.
During this time, this 24 year old man had developed a blockage in his hand that had become inflamed and eventua
During this time, this 24 year old man had developed a blockage in his hand that had become inflamed and eventua
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
lly ruptured, causing the possibility of amputation. The situation was brought under control using anti-inflammatory means, but he remained on his cholesterol medication without adjustment even after this incident.
About 6 months l
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ater, this young man was suffering from another blockage, but this time, it was in a critical area that couldn't be treated without specialization and the local doctors did not have the experience to treat him. These doctors told him
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hat there was no one in the 4 state area that could serve him, he was desperate and afraid, and turned to me for help.
When he first called, I asked him some questions to help me understand his situation.
How old are you? (25)
Do yo
When he first called, I asked him some questions to help me understand his situation.
How old are you? (25)
Do yo
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
u suffer from High blood pressure or high cholesterol? (yes)
Does your family have a history of high blood pressure, high cholesterol, heart disease, diabetes or insulin resistance? (yes)
Does you family have a history of bowel probl
Does your family have a history of high blood pressure, high cholesterol, heart disease, diabetes or insulin resistance? (yes)
Does you family have a history of bowel probl
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
ems, colon cancer or colon polyps? (yes, my twin brother)
What is your Ethnic Origin? (English)
Are you physically active? (yes, when I can be)
Has your doctor put you on any medication (yes, and he named it)
At the time that you
What is your Ethnic Origin? (English)
Are you physically active? (yes, when I can be)
Has your doctor put you on any medication (yes, and he named it)
At the time that you
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
ere put on this medication, did your doctor recommend a glycemic, low fat, low sodium diet? (no)
What kinds of foods have you been eating while on this medication? (regular foods, meat, vegetables, potatoes, you know, stuff in restau
What kinds of foods have you been eating while on this medication? (regular foods, meat, vegetables, potatoes, you know, stuff in restau
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rants and stuff that is easy to fix at home)
With the condition that you currently have, do you suffer from loss of vision or blurred vision? (yes)
Are you suffering from Migraine headaches? (yes, constantly)
Are you suffering from
With the condition that you currently have, do you suffer from loss of vision or blurred vision? (yes)
Are you suffering from Migraine headaches? (yes, constantly)
Are you suffering from
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
the loss of motor skills, have difficulty walking, chewing, swallowing, lifting? (yes)
Are these symptoms constant, or do they come and go? (Constant)
Is this blockage behind your right eye? (yes)
What has your doctor recommended?
Are these symptoms constant, or do they come and go? (Constant)
Is this blockage behind your right eye? (yes)
What has your doctor recommended?
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
they have recommended that I be treated elsewhere, because they do not have a specialist here)
Have they recommended a place you should go or a specialist that you should see? (no, they can't even tell me what kind of doctor I should
Have they recommended a place you should go or a specialist that you should see? (no, they can't even tell me what kind of doctor I should
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
get)
My recommendations were for him to seek help immediately, within the next week.
I suggested that his doctors give him a letter of recommendation to see a Cerebral Neuro-Vascular Surgeon. He and his friends got on the Internet
My recommendations were for him to seek help immediately, within the next week.
I suggested that his doctors give him a letter of recommendation to see a Cerebral Neuro-Vascular Surgeon. He and his friends got on the Internet
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
and found some specialists that could fit him in in the next few days. My fear was that the situation had gone on to long, and that he was in imminent danger. I told him that when he returned from his surgery, that he should call to
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
make an appointment with me so that we could get his blood pressure and cholesterol under control, so this would not happen again.
He asked me why this had happened in the first place, he had taken his medications like they had been
He asked me why this had happened in the first place, he had taken his medications like they had been
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
rescribed. I explained that when medications are used in the body, they have to not only act, but they are also acted upon.
When you use medications designed to reduce something in the body, you shouldn't add things that would cause
When you use medications designed to reduce something in the body, you shouldn't add things that would cause
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
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
the medications to have to compete or work harder to accomplish the goal. A cholesterol medication to control the fat in your blood, and then eat fat, or things that create fat. A diabetic medication to control blood sugar, and then
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
eat sugar or carbs that convert to sugars. A medication used for the treatment of gout, then eat things that are high in acid or create acid. These kinds of things can make the medications ineffective, and a waste of time and money.
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
He said that he had been on this medication for two years, and that the cholesterol numbers had never been affected by the medication. I told him that there is a way to lower his cholesterol effectively, using a restrictive diet, exer
.
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
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
cise, and a few supplements along with his prescription, and that as soon as he returned with relative health, we would start him on his program.
For most people, when they become ill, they go to their doctors in search of a quick fix
For most people, when they become ill, they go to their doctors in search of a quick fix
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
, a pill or a shot that will make things better instantly, that doesn't require any effort or discomfort on their part. The sad truth of the matter is that “possession” requires “responsibility”, and “responsibility” requires “action”
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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