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Your Space - The Shoemaker and the Brat
At seventeen years old, I was a brat. A mixture of innocence, immaturity and righteousness. And I carried that attitude with me everywhere, including my trip to the shoemaker.
Now, to understand why so
Now, to understand why so
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
mething as simple as a trip to the shoemaker would stay with me all these years later, I have to explain. I came from the most loving and nurturing parents a child could ever want. Even back then, I kne
; 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
I was blessed with a wonderful family, but this realization also made me a little arrogant. My fierce devotion to family could be blinding at times.
When my dad asked me to pick up his shoes from the
When my dad asked me to pick up his shoes from the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hoemaker, I eagerly obliged. Although he rarely asked, I loved doing favors for him and this was an easy request. Or so I thought. This simple errand proved more daunting than I originally anticipated,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
but it also provided me with a valuable lesson in life.
On my first attempt to pick up the shoes, I was informed they weren't ready. "Please, come back," the shoemaker said. However, although he said "
On my first attempt to pick up the shoes, I was informed they weren't ready. "Please, come back," the shoemaker said. However, although he said "
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lease", his response was curt.
As far as I was concerned, my dad never made mistakes, so I looked at the ticket and confirmed that I had the right date. "The ticket said they would be ready today," I r
As far as I was concerned, my dad never made mistakes, so I looked at the ticket and confirmed that I had the right date. "The ticket said they would be ready today," I r
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
sponded in an indignant tone.
"Tomorrow," was all he said. Then he turned to his next customer. I'm sure he didn't need a teenager lecturing him about his business obligations.
Prone to the dramatics
"Tomorrow," was all he said. Then he turned to his next customer. I'm sure he didn't need a teenager lecturing him about his business obligations.
Prone to the dramatics
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
of my youth, I rolled my eyes and left in a huff, complaining about his lack of responsibility under my breath.
When I returned the next day, ready to forgive him for the inconvenience, I was informed
When I returned the next day, ready to forgive him for the inconvenience, I was informed
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he shoes were not ready. Oh, you would think tragedy struck my perfect little world. My daddy needs his shoes, I though. How could the shoemaker be so inconsiderate? I stormed out of the shop without a
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
ord, but my body language spoke volumes.
My third trip (in three days) yielded the same results, and now I was furious at the shoemaker. Who did he think he was? What kind of a business was he running?
My third trip (in three days) yielded the same results, and now I was furious at the shoemaker. Who did he think he was? What kind of a business was he running?
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Without thinking, I demanded the shoes back. He complied with my request, grabbed the shoes from a large pile on his workbench and shoved them into a bag. "Here you go, young lady," he said with a smir
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
k.
I was fuming. I took the bag, bid him a sarcastic "thank you" and slammed the door on my way out.
When I got home, I explained everything to my dad. As usual, my dialog was animated. I clutched the
I was fuming. I took the bag, bid him a sarcastic "thank you" and slammed the door on my way out.
When I got home, I explained everything to my dad. As usual, my dialog was animated. I clutched the
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
bag, imitated the shoemaker and walked around the living room acting out my dramatic exit from the shop. Then I handed my dad the bag. He looked in it and smiled.
"Honey, I love you. I'm so happy that
"Honey, I love you. I'm so happy that
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
you care so much about my shoes, but what am I going to do with them now?"
That's when he pulled the shoes out. The heels were removed and the soles were cobbled out. They were useless, like a patient
That's when he pulled the shoes out. The heels were removed and the soles were cobbled out. They were useless, like a patient
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
pulled out of surgery before the doctor finished the operation.
"Patience, honey," he said gently. "There is no point in working yourself up over something that you have no control over."
I tried to a
"Patience, honey," he said gently. "There is no point in working yourself up over something that you have no control over."
I tried to a
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
gue with his logic. I told him the shoemaker had a job to do and he didn't live up to his obligation. My dad smiled again.
"Honey, think about it. It's just a pair of shoes. I have others. Choose your
"Honey, think about it. It's just a pair of shoes. I have others. Choose your
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
attles wisely and always deliver them with respect. Tomorrow you will bring the shoes back to the shoemaker and apologize. Explain that you understand he is busy and I am certain you will get positive r
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
esults."
That's how my dad conducts his life, with patience and respect, no matter what is handed to him. It's one of the many reasons I love him so much.
My father's response was not belittling or di
That's how my dad conducts his life, with patience and respect, no matter what is handed to him. It's one of the many reasons I love him so much.
My father's response was not belittling or di
.
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
respectful. He reminded me that we can't always have what we want when we want it. He showed me that our responses to a difficult situation show our true character. Acceptance, forgiveness and understan
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
ing are key elements to a healthy outlook on life.
Even to this day, whenever I am in a difficult situation, I remind myself not to be a heel, and always show sole.
Copyright 2004. All Rights Reserve
Even to this day, whenever I am in a difficult situation, I remind myself not to be a heel, and always show sole.
Copyright 2004. All Rights Reserve
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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