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Advice Pool - Are You Invisible?
Ellen was brought up to be invisible. She was taught to be very tuned into others’ feelings and needs, but to never have any of her own. Her family made it clear to her that her job was to give to them but to never
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
expect anything in return. As a result, Ellen learned to be totally tuned out to her own feelings and needs. It was as if she, as a person, didn’t really exist, other than to be there for others.
When Ellen’s fee
When Ellen’s fee
; 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
lings and needs did surface, she would tell herself that they weren’t important, that she was strong and could handle not having her feelings cared for and or her needs recognized. She convinced herself that if she
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
just cared enough about others, others would eventually care about her. It never happened.
The inner stress of never attending to her own feelings and needs and always feeling so invisible to others as a result f
The inner stress of never attending to her own feelings and needs and always feeling so invisible to others as a result f
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nally took a toll on Ellen’s health. Ellen is now dealing with cancer and finally has to attend to herself.
Many of us have learned to be invisible – to ourselves and to others. What are some of the ways you creat
Many of us have learned to be invisible – to ourselves and to others. What are some of the ways you creat
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e invisibility?
- Do you remain silent, not speaking up for yourself, when feeling discounted or unseen by others?
- Do you ignore your own feelings and needs in deference to others?
- Do you go alon
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
g with what others want, even if you really want something else?
Do you accept blame for things that you know are not really your responsibility?
Do you put aside your own opinions and accept the opinions
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
of others to be accepted?
Do you accept disrespectful behavior from others, finding ways to excuse the behavior?
Do you pretend everything is okay when you are really feeling lonely or sad?
Are you
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
onflict avoidant, preferring peace at any cost rather than rock the boat?
Are you carrying too much of the load at home or at work, without complaint?
Do you pretend to like a food, a movie, a topic of co
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
nversation, or sex, rather than run the risk of disapproval or rejection?
Do you allow yourself to be violated in any way – physically, emotionally, verbally, sexually – to avoid rejection?
Do you allow o
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
thers’ anger or bullying to control you into doing what they want?
Do you do everything yourself, never asking others for help?
How often do you end up feeling unappreciated, unseen, not valued? How mu
How often do you end up feeling unappreciated, unseen, not valued? How mu
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
ch of this is a reflection of how you treat yourself?
If your own feelings and needs are invisible to yourself, they will end up being invisible to others. It is not realistic to constantly put yourself aside and
If your own feelings and needs are invisible to yourself, they will end up being invisible to others. It is not realistic to constantly put yourself aside and
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
hen expect others to value and respect you. Anytime you tolerate uncaring or disrespectful behavior in others to avoid conflict, you are training others to see you as invisible, to not care about your feelings and
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
needs.
If you have been allowing yourself to be invisible for a long time, it is a real challenge to start to care about yourself. You need to be willing to go through a difficult period of feeling others’ anger a
If you have been allowing yourself to be invisible for a long time, it is a real challenge to start to care about yourself. You need to be willing to go through a difficult period of feeling others’ anger a
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
nd resentment. After all, you trained them for years to not have to care about you or see you, and now you are changing the rules. They won’t like it, but they will eventually respect you for it. You will also disc
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
over in the process of caring about yourself who really cares about you and who has just been using you. Those people who really care about you will eventually applaud your self-care, while those who were just usin
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
you will go away or be constantly angry with you for changing.
It takes great courage to shift from invisibility to being seen and valued. It takes great courage to be willing to lose others rather than continue
It takes great courage to shift from invisibility to being seen and valued. It takes great courage to be willing to lose others rather than continue
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to lose yourself. Yet, like with Ellen, your very life may depend upon it. Hopefully, you will not wait until you are ill or feel alone and cast aside by others to start to become visible to yourself.
It must star
It must star
.
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
t with yourself – with learning to tune into, acknowledge, value, and take loving action for yourself regarding your own feelings and needs. It means moving into personal responsibility for your own feelings and ne
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
eds rather than taking care of everyone else in the hopes they will eventually take care of you. If you are ever going to feel cared for and loved, it has to start with you caring about and being loving to yourself
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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