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Summary - Reliable
When I was a child this was the word that seemed to consistently appear on my school report card and I always thought it was such a let-down. I considered myself to be an adventurous, innovative and careful kid.
When
When
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
was the last time you heard ‘reliable’ said about a person, child or adult?
It seems to be one of those words that is slowly disappearing from our language these days – I don’t use it much either, which got me thinki
It seems to be one of those words that is slowly disappearing from our language these days – I don’t use it much either, which got me thinki
; 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
g when I was reading through my report cards from primary school.
You see, I have recently lost the last of my parents and am still sorting through the things they held onto from our childhood.
As a child, I always ‘
You see, I have recently lost the last of my parents and am still sorting through the things they held onto from our childhood.
As a child, I always ‘
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hated’ that description of my character. I used to think it was something they said about everyone because they couldn’t think of anything else to say about them. But now I’m older and realise it was probably a reasona
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ly accurate assessment of my character. You see, I’m still careful and I still do what I say I will. So, I guess that makes me reliable after all.
In today’s world, I know it is a character trait that I value – and fi
In today’s world, I know it is a character trait that I value – and fi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nally, I’m reasonably proud of it and will “walk backwards to Bourke” to keep this reliable tag.
Age does wonderful things for people, doesn’t it? Makes them grow and appreciate things that previously have been consid
Age does wonderful things for people, doesn’t it? Makes them grow and appreciate things that previously have been consid
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
red ‘not very exciting’ almost a ‘put-down’.
To be known as consistently dependable and of a steadfast nature and one worthy of trust was a ‘tag’ I actually grew into because I apparently had the character as a child
To be known as consistently dependable and of a steadfast nature and one worthy of trust was a ‘tag’ I actually grew into because I apparently had the character as a child
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
and never knew or appreciated it.
But now I know why it was always me who was asked to get the sheep into the shed in case it rained when we were kids and Dad had to leave the property during shearing time.
You see,
But now I know why it was always me who was asked to get the sheep into the shed in case it rained when we were kids and Dad had to leave the property during shearing time.
You see,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
f sheep get wet they can’t be shorn because the clippers can’t get through the heavy wool. This would have meant that the shearers would have been held up for days and cost Dad a lot of money – and the shearers may hav
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
e walked off the job and gone to another shed where there were sheep dry and waiting to be shorn.
Mind you I used to spend the time Dad was away, watching the sky. If I even saw a bit of cloud breasting the skyline, I
Mind you I used to spend the time Dad was away, watching the sky. If I even saw a bit of cloud breasting the skyline, I
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
would unleash the sheep dogs ready to head off to the paddock and start mustering the sheep. I had to start early because the dogs were ‘one-master’ dogs and rarely did anything I told them to. This probably helps to a
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
count for the fact that I was a pretty good runner – I had to do a lot of running to get those sheep mustered and into the shed before the rain started.
I always remember the one time I barely made it. It was one of t
I always remember the one time I barely made it. It was one of t
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
hose freakish thunder storms that used to come up during a hot summer afternoon. The sky got darker and darker, the sheep started to get spooked and the dogs almost started to work properly. Mum even came up to the woo
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
shed to help me.
The thunder was booming right overhead and the lightning was getting too close for comfort. I was about half way through getting the sheep into the yard when Mum arrived. Now the dogs really started t
The thunder was booming right overhead and the lightning was getting too close for comfort. I was about half way through getting the sheep into the yard when Mum arrived. Now the dogs really started t
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
o work – they decided this must have been serious so they started to really work properly and we soon had the sheep into the outside yard.
Then there was this sizzling flash and BOOM when the tree just outside the yar
Then there was this sizzling flash and BOOM when the tree just outside the yar
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
splintered and smoked as it was hit by a lightning strike. Dogs yelped and ran for their kennels while Mum and I pushed the sheep inside just as the rain started to pelt down – then we followed the sheep inside and c
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
losed the big sliding doors.
Climbing over the terrified sheep’s backs, Mum and I made our way up the ramp, through the pens, and sank onto the bales of wool stacked to the rafters inside the back of the shed. There
Climbing over the terrified sheep’s backs, Mum and I made our way up the ramp, through the pens, and sank onto the bales of wool stacked to the rafters inside the back of the shed. There
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s an unmistakable odour about a wool shed when you are shearing. – Frankly, it’s more of a stink rather than an odour. The Urea is so strong its’ a bit like being locked up in an ammonia bottle!
Then the hail started
Then the hail started
.
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
– the woolshed was all galvanised iron so the noise was deafening! It didn’t matter though any more because the sheep were dry and ready for the coming week’s shearing.
Mum and I cuddled up on the wool bales and liste
Mum and I cuddled up on the wool bales and liste
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
ed to the din because we couldn’t hear each other speak above the racket. And then it was all over – finished as fast as it hit.
But it didn’t matter because I had proven to Dad again that he could always depend on me
But it didn’t matter because I had proven to Dad again that he could always depend on me
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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