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Useful Advices - Safety Comes First When Working With Glass
Several years ago, I was doing the night shift in a gasoline service convenience store. I was working with another clerk. It was that sleepy time of the morning between 4:3
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
0 and 5:30. This is the time of the night shift where you are most likely to fall asleep or micro nap on your feet. It was also a quiet time for customers when the produce
; 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
nd cold drink cooler could be restocked. The temperature inside was usually just above forty degrees. I hoped that the cold inside would help me wake up.
The cooler was di
The cooler was di
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
vided into a milk section on the far right. Then came juice to the left. In the middle was a small meat and cheese section. Left of the produce was a sports drink section.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Last of all on the far left was the soft drink section. First, I started filling up the milk section which had various sizes to be filled. The plastic crates holding four
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
f the large size of milk are quite heavy to move. After filling the milk section up the remaining crates were restacked and the empty crates were removed.
Moving on to the
Moving on to the
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
juice section was faster. I could grab glass juice containers from a storage shelf and restock the display. Sometimes condensation that formed on the glass bottles of juice
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
That must have happened again. While lifting a small bottle of juice up to place it on an upper shelf the bottle slipped from my hand. In a split second, I knew that clea
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ing up the juice and broken glass on the floor under the shelves would take too long. I made an instant decision to grab the bottle as it fell in mid air to stop it breaking
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
when it hit the floor. As I grabbed the glass bottle, it hit one of the shelves on the way down. The glass bottle broke in my hand as I clutched it. Right away, I felt th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
warm wet feeling of blood on my hand and the bite of the glass inside my thumb. I was pouring out blood. Quickly I pulled out the piece of glass from my thumb. Somewhere
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
found some paper towel and covered my bleeding thumb. I clamped my good hand around the paper towel and thumb. Applying pressure helped slow the loss of blood.
Leaving th
Leaving th
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
e cooler, I found the other clerk. I told her about being cut badly. Just by chance, there was a taxicab at the store then. The cabby was kind enough to drive me over the
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
ridge one street away to the nearby hospital.
I was going to need stitches in my thumb. The doctor was called at home to come to the hospital. It took twenty minutes to ha
I was going to need stitches in my thumb. The doctor was called at home to come to the hospital. It took twenty minutes to ha
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
f an hour for him to arrive. While waiting I started to feel a bit light headed so laid down on an examining table. When the doctor arrived, he had a look at my cut and con
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
firmed my suspicion that it needed stitches. The soft fleshy pad of my thumb where the finger print usually is was hanging by a small piece of skin.
The doctor injected my
The doctor injected my
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
thumb in several places to freeze it before starting the sewing. I think he put in about ten to fifteen stitches. I did feel the needle going in and out of the skin. That
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
as nothing compared to when the freezing wore off. The wound screamed at me, releasing pain for hours that day. After the doctor finished sewing me up he said to go home an
.
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
d rest. He suggested not going to work for a couple of days.
There were nerves that were cut in the thumb. It took years before they grew back in place and started working
There were nerves that were cut in the thumb. It took years before they grew back in place and started working
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
Until then the thumb pad had no feeling. It was completely numb.
From that I learned not to catch falling bottles. It is much easier to clean up a little glass and juice
From that I learned not to catch falling bottles. It is much easier to clean up a little glass and juice
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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