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Advice You - Concentrate On The Task At Hand
As a kid, I liked the teams involved in the current World Series, the Detroit Tigers and the St. Louis Cardinals. Al Kaline was “Mr. Tiger” and represented what baseball is all about. And ev
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
en though Ty Cobb played before my time, when you think of the Detroit Tigers, the legendary “Georgia Peach” has to come to mind. Advancing through the years, no baseball fan could forget ma
; 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
nager Sparky Anderson, who after winning the World Series twice with the Cincinnati Reds in the mid-seventies, led the Tigers to a championship in 1984.
The Cardinals were “the team” in Wes
The Cardinals were “the team” in Wes
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t Tennessee where I was born and reared. Along with listening to their games on radio, my father, brother, and I made annual week-long visits to St. Louis to see the Cardinals play. Enos “Co
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
untry” Slaughter and Stan “The Man” Musial were my favorites. Today, Cardinal manager Tony La Russa is special to me for several reasons. This World Series winner with the Oakland Athletics
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
wrote a testimonial for my “A Strategy For Winning” book. He is also a good person, joining with his wife and daughters in benevolent endeavors, especially the La Russa Family Animal Rescue
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
Foundation.
A couple of things that caught Tony’s attention in “A Strategy For Winning” are the emphases on being mentally tough and accepting responsibility. He wrote: “Carl Mays deals wit
A couple of things that caught Tony’s attention in “A Strategy For Winning” are the emphases on being mentally tough and accepting responsibility. He wrote: “Carl Mays deals wit
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
some important principles. He spotlights the fact that all successful people have problems to overcome, and he emphasizes that unless you accept personal responsibility and make a personal
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
commitment, you cannot win. His advice to concentrate on what you do have rather than on what you don’t have is fundamental, but often neglected...”
As I write this column, the Cardinals ar
As I write this column, the Cardinals ar
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 leading the Tigers 2-1 in the series. The three winning pitchers have all shown extraordinary mental toughness and have fully accepted personal responsibility to lead their teams to victor
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
y. Even though there have been some hitting heroes, pitching has dominated the series so far. In game one, rookie Anthony Reyes, with a record of 5-8, surprised a lot of people when he power
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
fully led the Cardinals to victory after struggling in the first inning. Cardinal pitching coach Dave Duncan said Reyes “got his mind right and focused on what he had to do.”
In game two, D
In game two, D
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
etroit’s Kenny Rogers took control of things. Following his performance, manager Jim Leyland, who led the Florida Marlins to a World Series championship in 1997, said, “The pine tar and scuf
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
fed ball comments overshadow the fact that Kenny pitched a terrific game.” Someone else said athletes are always looking for a mental and physical edge and even though much has been made 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
ogers’ alleged tactics, “his edge was more mental than physical tonight.”
In game three, Cy Young winner Chris Carpenter showed why he is considered one of the best pitchers in baseball tod
In game three, Cy Young winner Chris Carpenter showed why he is considered one of the best pitchers in baseball tod
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
ay, shutting down the Tigers as St. Louis claimed a 5-0 victory. Following the game, La Russa said of Carpenter, “He’s so strong between the ears that nothing fazes him. He’s got a good head
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
, good heart, good guts.” Cardinal catcher Yadier Molina said Carpenter’s concentration was unshakable. Carpenter’s comments were, “Go one pitch at a time. All that stuff around you that’s g
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
oing on doesn’t get in your head, so you’re not even thinking about it. You’re just thinking about what you’ve got to do to get the job done.”
Possessing mental toughness and accepting pers
Possessing mental toughness and accepting pers
.
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
onal responsibility are not relegated to athletics. In our careers and lives there are times when one thing after another seems to overwhelm us and bring us down. That’s when we are challeng
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 concentrate on the task at hand, to focus on the one thing that will help us accomplish the one job that needs to be completed in order to take care of the higher goal on down the line
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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