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Advice Pool - Getting in Shape For Lazy Bastards
Okay so let me get this straight... You don’t feel like making exercise
a daily habit, you don’t like the feeling of being out-of-breath, and you’d
rathe
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
r stay the way you are if it means being comfortable...even if you
do become an even fatter and lazier bastard in the process?
Ladies and Gentlemen - wh
Ladies and Gentlemen - wh
; 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
t you’ve just read above is the exact mindset
that most out-of-shape people have when attempting to get in shape. And
when they fail, they actually ask the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
obvious question of why they have failed...
Sad isn’t it?
As opposed to those types of people, I have come in contact and trained people who did have the d
As opposed to those types of people, I have come in contact and trained people who did have the d
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
sire to change their daily habits with the goal of getting in
shape and being healthier. Now this is the mindset of a few select people who
want to get in s
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
hape - and it’s a good mindset to have. But again, I’ve also seen
people fail to get in shape with this wonderful mindset...
The reasons: Okay, for the lazy
The reasons: Okay, for the lazy
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
mindset - it’s obvious why they fail. If you go
into any activity with the “I don’t feel like it” mood, guess what, you most likely
will fail and you won’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
get anywhere because all of your energy will be focused
on not wanting to be there doing whatever is it you’re doing. Or for some fat and
lazy people, their
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
energy will be focused on which flavored donut they’ll purchase
when the training is over. Whatever it is you focus on while physically training, if
you’re
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
focus is not centered on progression and self-improvement - you are doomed to fail.
As for the pre-motivated types, the reason why some of th
As for the pre-motivated types, the reason why some of th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
m fail is because they
lack consistency after they start training. To give you a more clear vision on what
I mean, I’ll tell you about a particular client I
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
began to train recently...
A friend of mine heard about my fitness training services one day and decided that he wanted me to help him get in shape. He call
A friend of mine heard about my fitness training services one day and decided that he wanted me to help him get in shape. He call
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
ed me up and we met at a
location. He was so worked up and was motivated to get in shape and have more
daily energy - and with this mindset, he couldn’t pos
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
ibly fail, could he? Well, for
the first few days he used my advice and trained really hard and actually started
to make progress. However, one day, a day
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
in which he scheduled physical training
for himself, he decided to slack off and ‘take a break’. So he did take a break for
that one day... And soon, that o
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
e day off turned into 5 days off!
Can you believe that? He quit training for one day and resumed back to his old habits...and all the progr
Can you believe that? He quit training for one day and resumed back to his old habits...and all the progr
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
ess he made from improving his stamina to increasing
his muscle base all disappeared within a week. He basically threw every little
progress he made out the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
window. And after that, he simply forgot about training.
Of course, being the persistent S.O.B. I am, I pushed him forward after hearing about his “fall” an
Of course, being the persistent S.O.B. I am, I pushed him forward after hearing about his “fall” 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 he did achieve his fitness goals after about a month of
consistent training (powered by me).
But the main lesson to learn here is this: No matter what shap
But the main lesson to learn here is this: No matter what shap
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
, size, or physical
state you are in, if you train consistently, you will succeed at getting in shape and
achieving your goals in a reasonable amount of time
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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