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Summary - Hey, Watchya Doin?
More than two decades ago, Paula came to work in the task area where we shared an office.
She had been given the position I had been vying for. It didn't seem at all fair. I labored to make her feel uncomfortable and unwanted.
But be
She had been given the position I had been vying for. It didn't seem at all fair. I labored to make her feel uncomfortable and unwanted.
But be
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
cause of her indomitable spirit she kept pressing onward with her positive attitude, generous smile, and infectious friendliness.
But I was not easily won over. I was miserable and worked overtime to counter her goodness.
Deep down I
But I was not easily won over. I was miserable and worked overtime to counter her goodness.
Deep down I
; 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
had to admit there wasn't much about her to not like. She was Pollyanna and I was "The Bad Seed."
Shame and guilt eventually made me feel loathsome. Perhaps she saw through my bristly facade. I truly hope at the time there was some es
Shame and guilt eventually made me feel loathsome. Perhaps she saw through my bristly facade. I truly hope at the time there was some es
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ence of good that glinted from my soul's innards. I'm guessing there was and she coaxed that spider silk thread out with her charm and began to weave the web of our friendship.
Understandably, a friendship is a two-way mechanism. A re
Understandably, a friendship is a two-way mechanism. A re
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ationship functions best when both individuals proffer the finest qualities from their heart and soul. I had a lot of catching up to do and, consistent with my nature, I extended myself wholeheartedly.
Her friendship was a shining gem
Her friendship was a shining gem
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
that sparkled brightly before my eyes. What she offered was beyond description or value. The bond that two beings can cement which lasts a lifetime... Friendship!
The saying, "Hey, watchya doin'?" became a part of our bitter, joyous,
The saying, "Hey, watchya doin'?" became a part of our bitter, joyous,
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
disheartening, thrilling, ecstatic, crushing, and wondrous happenings that living life brings.
Those were the words I stammered the night I drove over to her house and apologized for how I had treated her when we first met, admitting
Those were the words I stammered the night I drove over to her house and apologized for how I had treated her when we first met, admitting
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
had been cruel.
I should have gone to her earlier in our relationship and apologized. She never spoke of my treatment of her in those first days. She never told me that my actions had hurt her.
But when I asked her to forgive me she
I should have gone to her earlier in our relationship and apologized. She never spoke of my treatment of her in those first days. She never told me that my actions had hurt her.
But when I asked her to forgive me she
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
began to cry and all the pain I had been responsible for was etched on her face. She merely nodded.
Then smiled at me.
We hugged and cried together.
I heard those words from her during the rough days when her marriage was falling ap
Then smiled at me.
We hugged and cried together.
I heard those words from her during the rough days when her marriage was falling ap
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
rt and she needed to talk. When there was a suicide in the family she spoke that phrase through the tear-choked pain of loss.
Though we no longer work in the same area, we still work for the same organization. No matter where the job
Though we no longer work in the same area, we still work for the same organization. No matter where the job
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ssignment, stress is part and parcel of the job. And many times we've phoned the other with the question, "Hey, watchya doin'?"
We have seen heartbreaking human suffering, abuse, and loss. As much as we might try to "leave it all at t
We have seen heartbreaking human suffering, abuse, and loss. As much as we might try to "leave it all at t
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
he office" we cannot always shove it in the desk drawer, turn off the lights and head home with a peaceful spirit.
It is at such times we have sought solace in each other.
"Hey, watchya doin'?" she said. "Why don't you come on over t
It is at such times we have sought solace in each other.
"Hey, watchya doin'?" she said. "Why don't you come on over t
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
night for dinner? We need to talk." I did, and she introduced me to her fiance -- a wonderful man who would give her all that she deserved. The joy of a good marriage. She was long overdue!
She has asked me that question when her voic
She has asked me that question when her voic
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
bubbled over with happiness because she wanted to tell me her daughter was engaged. And again, twice, each time she learned her daughter was pregnant.
"Hey, watchya doin'?"
That evening we got together and shared our fears. We were
"Hey, watchya doin'?"
That evening we got together and shared our fears. We were
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
o longer young women and the fast rushing reality of years gone by seemed to hit us at roughly the same time.
"My folks are getting older. Oh, Kathy! I am so afraid of losingthem."
Tears burned hot in my eyes. "Me, too." My father ha
"My folks are getting older. Oh, Kathy! I am so afraid of losingthem."
Tears burned hot in my eyes. "Me, too." My father ha
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
died years earlier but my mother and step father were still alive and very much a part of my life.
"Hey, watchya doin'?" I asked one late afternoon. "I just got in from work."
"Why?" she replied.
Emotion choked me as I tried to squ
"Hey, watchya doin'?" I asked one late afternoon. "I just got in from work."
"Why?" she replied.
Emotion choked me as I tried to squ
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
eeze the words past my constricted throat. "I have cancer..."
On another afternoon, when I woke up from surgery, I saw her face. By her side was her youngest daughter. They both smiled tremulously.
Their eyes shimmering wet. Their ex
On another afternoon, when I woke up from surgery, I saw her face. By her side was her youngest daughter. They both smiled tremulously.
Their eyes shimmering wet. Their ex
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ressions full of love and hope. They had a gift and a card for me, but to this day I cannot tell you what the gift was.
All I saw was the glow of a loving friendship reflecting back to me -- the years we had shared our secrets and hop
All I saw was the glow of a loving friendship reflecting back to me -- the years we had shared our secrets and hop
.
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
s, our fears and triumphs.
"Love you!" she said.
"I love you, too." I garbled roughly through my tears. "Thank you for being my friend."
Two and a half years have passed since that afternoon. We still greet each other with that old
"Love you!" she said.
"I love you, too." I garbled roughly through my tears. "Thank you for being my friend."
Two and a half years have passed since that afternoon. We still greet each other with that old
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
hrase. And every now and then we will say...
"Love you! Thank you for being my friend."
And when I say those words, I count myself blessed to have your friendship, Paula.
"I love you. Thank you..."
Copyright 2004 Kathy Pippig Harri
"Love you! Thank you for being my friend."
And when I say those words, I count myself blessed to have your friendship, Paula.
"I love you. Thank you..."
Copyright 2004 Kathy Pippig Harri
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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