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Main Subject - A Lesson of Survival in the Always-in-Touch World
Simon sauntered. It was rare that he had the chance to take a lunchtime walk beside the city’s river. He wasn’t going to waste this one. And in any case, he desperately needed some space. Obli
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
vious of the grey skies, the grey path and the rush of other grey suits weaving their way around him, he wrapped himself in his thoughts.
It was the music which caused Simon to stop. A busker
It was the music which caused Simon to stop. A busker
; 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
was playing his harmonica with an energy that even the most distracted mind couldn’t avoid.
The musician was playing fast and loud, notes spilling from his instrument with the enthusiasm of a
The musician was playing fast and loud, notes spilling from his instrument with the enthusiasm of a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
happy child. Combining complex riffs into a frenzied melody, his sound was a splash of colour on the dull canvas of the day.
His small audience – those who weren’t rushing to their next meeti
His small audience – those who weren’t rushing to their next meeti
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ng – stood dumbstruck in wonder. They clapped as he finished and, as he stepped back for a break, the generous chatter of change into his hat reinforced their appreciation.
As he sat down, th
As he sat down, th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
harmonica player looked up and noticed Simon standing, motionless, staring through him to the river behind.
“I’ll be starting again in a min…” he said before interrupting himself. “Man, you
“I’ll be starting again in a min…” he said before interrupting himself. “Man, you
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
ook terrible. Who stole your happy pills?”
Simon refocused on the busker. “Tough day,” he said with a sigh and just the hint of a resigned smile. “Tough year, in fact.”
Simon wandered over t
Simon refocused on the busker. “Tough day,” he said with a sigh and just the hint of a resigned smile. “Tough year, in fact.”
Simon wandered over t
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
owards the musician and, without being prompted, he continued. “I’ve got 250 emails in my inbox and I can’t clear them out because they keep coming as quickly as I read them. I can’t even get
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
break by leaving the office because my BlackBerry means that anyone can get hold of me at any time, by phone or email or text message. There’s no escape. No one ever told me that being a mana
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
er would mean working 24/7.”
The harmonica player thought about Simon’s predicament for a moment. “I can’t tell you much about management,” he said, “but I reckon I can teach you one thing. W
The harmonica player thought about Simon’s predicament for a moment. “I can’t tell you much about management,” he said, “but I reckon I can teach you one thing. W
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tch this.”
With that, the harmonica player stood up at his microphone again. He put his instrument to his mouth and started playing a simple train-like rhythm with just two notes. Doo Doo Dah
With that, the harmonica player stood up at his microphone again. He put his instrument to his mouth and started playing a simple train-like rhythm with just two notes. Doo Doo Dah
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
Dah. Doo Doo Dah Dah… Slowly he built the speed of the rhythm while continuing to use just the two notes he’d started with.
With subtle variations, the busker created an almost tribal rhythm
With subtle variations, the busker created an almost tribal rhythm
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
which resounded around the plaza. Within minutes, a crowd had gathered, bigger than the crowd of a few minutes earlier. Rather than standing in awe, this crowd couldn’t help but move. They tap
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
ed their feet and rocked their bodies. Some started dancing.
The music continued for a few minutes and concluded with rapturous applause, shouts for more and the rattle of more change into th
The music continued for a few minutes and concluded with rapturous applause, shouts for more and the rattle of more change into th
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
e hat on the ground.
Simon watched all this in wonder, but he wasn’t sure he understood what the musician was trying to tell him.
The harmonica player smiled. “What I just played can be play
Simon watched all this in wonder, but he wasn’t sure he understood what the musician was trying to tell him.
The harmonica player smiled. “What I just played can be play
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
d by any first year harmonica player. Yet the crowd were moved by it more than all the fancy stuff I was doing earlier. Sometimes I need to remember a lesson I was taught early on in my music
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
areer:
Just because you can doesn’t mean you must.
He paused to let Simon absorb his words, then went on. “Don’t you think that same lesson might apply to you? You’ve go
Just because you can doesn’t mean you must.
He paused to let Simon absorb his words, then went on. “Don’t you think that same lesson might apply to you? You’ve go
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t all this fancy techno stuff which allows you to be on the job around-the-clock. So you’re letting it keep you on the job around-the-clock.”
Simon stared out at the river in thought for some
Simon stared out at the river in thought for some
.
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
time. “Just because I can doesn’t mean I must,” he said, half to himself. He pulled his mobile phone out of his pocket and pointed to the off button. With a knowing grin, he said, “So perhaps
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
need to use this more often?”
The harmonica player nodded.
A resolved look crossed Simon’s face. “Thanks,” he said, and, looking up at the brightening sky, he started back toward the office
The harmonica player nodded.
A resolved look crossed Simon’s face. “Thanks,” he said, and, looking up at the brightening sky, he started back toward the office
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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