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Top Articles - The Cutting Room Floor
A blank screen and brain to go with it! The heavy rain outside, followed by a bright spark that informs me the weather is better in the UK! A depressing fact, but thankfully not often true. Th
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
e Catalan people like the British love to discuss the weather. The river Ebro is used like a huge barometer with families over Easter all going to look at this mass of raging water. Almost secre
; 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
tly spring has arrived with everything turning that vivid shade of green only waiting for the sun to put the finishing touch on it. By the time you are reading this the thoughts of building an 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.
rk will be over!
Last year I mentioned that I was involved, but not at liberty to write about a TV program on this area. Thinking back to it makes me smile. To start with I didn’t want to be in
Last year I mentioned that I was involved, but not at liberty to write about a TV program on this area. Thinking back to it makes me smile. To start with I didn’t want to be in
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
volved, as some four years earlier I had been and though it was good publicity for the area it was so misleading about the property market. Generally people want to believe what they see on the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
screen, even if the content is designed to be entertaining more than informative. With this experience I stated that I wanted to know the content and depth of the subject matter to be covered be
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
fore I agreed to take part. After the battles with young the “researcher” that had a Masters Degree in avoidance of questions, I finally got a brief of the planned program.
Two month before fil
Two month before fil
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
ing the daily phone calls with more and more questions started “do I really want to be involved with this?” At the first meeting with the research team, held in a local hotel. I was pleasantly s
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
hocked to find that some of my suggestions were going to be included! I was given more information about the couple that were the buyers and selected properties to be filmed.
Now the program i
Now the program i
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
s filmed to appear that it was made in one day, not the four long days plus the return extra bits! The weather was kind to us – it didn’t rain but was too bright for some of the filming!
The re
The re
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
searchers, the sound engineers, camera crew, the “buyers” and presenter were all staying in the same hotel. By day three the tension was showing …..The buyers were complaining about the hours sp
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
ent in front of the camera and not having any free time, breakfast, and most of all the fact that they had to wear the same clothes every day for continuity! The presenter was just anxious! 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
camera crew were almost crazy with the heat. The sound man just wore a grin and poured water over his head at every opportunity. The researchers were the only ones that remained calm and profess
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
ional to the end! If there was any glamour in this work I did not see it.
Once filming of the buyers and properties were over, then all the extra bits that make up the program are shot. This of
Once filming of the buyers and properties were over, then all the extra bits that make up the program are shot. This of
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
course was done at various locations covering different topics. The legal side in the form of a question and answer section with the presenter and a lawyer took two hours to set up and film. Les
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
s that a minute was shown!
To get good light to film basket weaving in a village it was arrange to start filming at eight in the morning. At ten the “ladies of the baskets” still could not be f
To get good light to film basket weaving in a village it was arrange to start filming at eight in the morning. At ten the “ladies of the baskets” still could not be f
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
ound. I did suggest that maybe they had not made it clear that it was eight am.
On viewing the program as it was broadcast I felt sorry for the viewers as I reckon It would have been more infor
On viewing the program as it was broadcast I felt sorry for the viewers as I reckon It would have been more infor
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
mative and very entertaining to have seen the entire film that was shot.
I thank the owners of the properties filmed, as not only did they give us their time, they allowed this “crew” into thei
I thank the owners of the properties filmed, as not only did they give us their time, they allowed this “crew” into thei
.
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
r home for hours. Part of the program is to film the reaction to the property from the buyers. This was often offensive and critical of personal taste within the home filmed. Luckily most of thi
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
s was edited out of the final program. The buyers did not get what they wanted - A free holiday in Spain! I believe they did what they planned to before the filming started and brought in France
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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