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Your Space - Leaving Comfort for Possibility: Five Strategies for Experiencing More of Life
Many people lead their lives from a safe, familiar, comfortable place. Their lives are good, but they are secretly wishing they could be more, do more, and experience more. They are eager to step over the
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
threshold of comfort and out the door, yet not quite sure how to do it, or where to go once they are “out there”.
What is going on in yo
- 1.Become Aware
What is going on in yo
; 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
r life? What is good…or great? Where are you comfortable? Becoming aware of, and acknowledging what is currently going on in your life right now offers a solid foundation to build upon. Think and write abo
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 all the areas of your life including relationships, career, friendships, recreation, self-care, spirituality, finances…that are working, exciting, good… Now, looking at each area, identify where you are 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
fortable, and whether that comfort is working for you or not. What about the areas you are challenged by?
What do you want to a
- 2. Clarify Your Direction
What do you want to a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
dd to your life, change in your life, or remove from your life? What is important to you that you are not experiencing, but would like to? Understanding and discovering your own purpose, needs, values, int
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
rests and gifts will open up new worlds of possibility when you begin to incorporate them into your life. As you go through each day, carry around a small notebook and pen. When you experience a surge of e
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
ergy or excitement, write down what you were doing when your energy changes for the better. Do the same when your energy suddenly becomes deflated. Were those shifts in energy more apparent when you were i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
your comfort zone, on the threshold of your comfort zone or stepping away from it?
- 3. Question and Challenge Your Thoughts and Actions
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
from comfort to possibility?
Being comfortable is familiar, safe, secure, cozy, and often uncomplicated. No wonder why we all too often stay there. Being comfortable is good, but in order for our live
Being comfortable is familiar, safe, secure, cozy, and often uncomplicated. No wonder why we all too often stay there. Being comfortable is good, but in order for our live
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
to be great, fulfilling, exciting and exhilirating, we must often venture away from the comfortable and familiar into unchartered territory, and grow beyond what we know. When we begin to try something new
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
and different, what often pops up are all of the “what ifs” that we are telling ourselves and the habits we have created to keep us just where we are. Think about, and list, all of the “what ifs” you tell y
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
urself that stall you, prevent you, or challenge you as you move forward with your next project, venture, and idea in your life. Going forward, every time you begin to hear those “what ifs’”, write them out
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
, even if they are repeated, and ask yourself if you truly believe them.
When you are concentrating on many differe
- 4. Focus Your Energy
When you are concentrating on many differe
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
t directions at one time, or you are not quite certain which direction to take, you can become overwhelmed. When you are clearly focused, like a beam of light, your path becomes clear and your actions purpo
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
eful. This focus brings an abundance of energy that will keep you moving between the ‘big picture” of what you want for your life and the “details” of your daily actions, monthly goals. Create a vision for
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
your future 5 years from now. Working backward, think about what would have to happen to achieve that vision, at 4 years, 3 years, 2 years, 1 year, 6 months, next month, today. Create a plan with small, me
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
asurable steps to help you then move forward.
Create a support team to help you achieve your goals. I say t
- 5. Support Your New Life
Create a support team to help you achieve your goals. I say t
.
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
am, because attempting to do this alone, or relying on just one person to help you will often not get you very far. Your support team could include your spouse or partner, trusted friends, siblings, mentors
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
your community, church, and even a life coach. The important thing to remember when choosing your team is the word support. Ask yourself if all of these people will truly support you in ways that you need
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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