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References - Wish You a Merry Christmas
It was December 22, a Saturday, and the last weekend before Christmas. She was getting some last minute shopping done. After making her purchases she walked with her son over to the cottage covered in artificial snow that sat in the middle of the shopping mall. She had promised her son that he could visit Santa.
Her son was eight years old; tall and lanky like his father.
Her son was eight years old; tall and lanky like his father.
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
He had dark auburn hair and gray-green eyes, a sprinkle of freckles on his cheeks and a wistful smile. His voice was gruff for a boy so young, prompting many folks to refer to him as the "little man."
Since his father's untimely and sudden death seven months earlier he had tried to fill his daddy's place by volunteering for extra duties around the ranch and his once-boyish
Since his father's untimely and sudden death seven months earlier he had tried to fill his daddy's place by volunteering for extra duties around the ranch and his once-boyish
; 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
mannerisms quickly gave way to an assumed adult demeanor.
Juggling her packages she gently prodded her son forward when the elf assistant informed them it was her son's turn to sit with Santa.
She couldn't hear what the shopping mall Santa and her son were saying, but she couldn't help notice her son's expression. His gray-green eyes sparkled with unshed tears and his li
Juggling her packages she gently prodded her son forward when the elf assistant informed them it was her son's turn to sit with Santa.
She couldn't hear what the shopping mall Santa and her son were saying, but she couldn't help notice her son's expression. His gray-green eyes sparkled with unshed tears and his li
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ps trembled as he nodded his head in response to something Santa said. An elf with a camera told her son to smile as he snapped a couple of shots. Her son looked past the camera. His thoughts miles distant. The only one who smiled was Santa.
Once in the car she asked her son what he had told Santa he wanted for Christmas. He turned his head toward the window. His words bou
Once in the car she asked her son what he had told Santa he wanted for Christmas. He turned his head toward the window. His words bou
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nced off the glass with a dull echo. "I want to tell daddy I love him. I want him to hug me. and tell me, 'I love you, buddy!' when he tucks me in at night."
She tried to draw a breath past the painful lump in her throat. "I know, honey. We weren't able to say goodbye. We weren't there to hug him up and savor his goodness one last time...I'm sorry, hon."
He hung his head.
She tried to draw a breath past the painful lump in her throat. "I know, honey. We weren't able to say goodbye. We weren't there to hug him up and savor his goodness one last time...I'm sorry, hon."
He hung his head.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
"Me, too," he muttered in his gruff little boy voice. The hour it took to get home was quiet.
***
That evening as they decorated the tree a storm crept out over the flat range, groaning with snow laden clouds and whining winds. Soon wet heavy snow was pounding at their windows and icy fingers of the wind crawled under the doors and into the house.
"We'd better check on
***
That evening as they decorated the tree a storm crept out over the flat range, groaning with snow laden clouds and whining winds. Soon wet heavy snow was pounding at their windows and icy fingers of the wind crawled under the doors and into the house.
"We'd better check on
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
the horses. I'm concerned this storm will spook the mare who's due to foal any day now. And I want to make sure the chickens are locked up good and tight."
"Okay, Mom. I'll check on the chickens." He picked up the boxes of ornaments from the floor and placed them on the nearby couch. "We can get to the rest of this later."
She cast a proud glance at her son. "Yes, my litt
"Okay, Mom. I'll check on the chickens." He picked up the boxes of ornaments from the floor and placed them on the nearby couch. "We can get to the rest of this later."
She cast a proud glance at her son. "Yes, my litt
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
le man. We can." She grabbed their coats and scarves from the coatrack. They bundled up and went outside.
The flood light from the roof of the barn was little help as the gusting wind tossed thick folds of snow everywhere. Pushing against the wet and cold she reached the barn, threw back the retaining bar and went inside. She flicked the lights on and took a relaxing breat
The flood light from the roof of the barn was little help as the gusting wind tossed thick folds of snow everywhere. Pushing against the wet and cold she reached the barn, threw back the retaining bar and went inside. She flicked the lights on and took a relaxing breat
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
h. It was suddenly more quiet and calm within. She scanned the stalls. All was peaceful. The horses were fine. The pregnant mare dropped her head over the stall half-door and huffed a welcome.
He opened the door to the coops and warm air brushed 'round him. The heat lamps were on bathing the chickens in a red glow. They were settled in for the night. Some sleeping, while o
He opened the door to the coops and warm air brushed 'round him. The heat lamps were on bathing the chickens in a red glow. They were settled in for the night. Some sleeping, while o
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
thers clucked softly in the shadows. He pulled his scarf tightly around his neck as he shut and bolted the coop up. As he turned towards the barn he was stopped short by a sound.
There, in the blustery snow was a dark shape. A whimpering sound issued from the quaking creature. The boy gingerly stepped closer. He saw a black ball of fur. The head trembled as it whined piteo
There, in the blustery snow was a dark shape. A whimpering sound issued from the quaking creature. The boy gingerly stepped closer. He saw a black ball of fur. The head trembled as it whined piteo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
sly.
The wind died down and the boy got a better look at the animal. "Come here, pooch." He coaxed softly. He squatted down nearer the dog and held his hand out. The black dog stood slowly, then reached over and licked the boy's hand. Holding his arms out the boy called the dog to him. In a bound the dog crawled into his arms--all the while licking the boy's face.
He met
The wind died down and the boy got a better look at the animal. "Come here, pooch." He coaxed softly. He squatted down nearer the dog and held his hand out. The black dog stood slowly, then reached over and licked the boy's hand. Holding his arms out the boy called the dog to him. In a bound the dog crawled into his arms--all the while licking the boy's face.
He met
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
his mother just outside the door to the barn. She gasped sharply when she espied her son and the creature in his arms.
"What do you have there?" She knew, but she was caught by surprise.
"Can we go inside?" he implored, staring down at the dog. "He's freezing out here."
"Umm." She nodded and hustled herself and her boy towards the house.
Shutting the front door behind h
"What do you have there?" She knew, but she was caught by surprise.
"Can we go inside?" he implored, staring down at the dog. "He's freezing out here."
"Umm." She nodded and hustled herself and her boy towards the house.
Shutting the front door behind h
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
er she faced her son. "Let's take a better look at him, shall we?" She drew closer then wrinkled her nose. "He will need a hot bath. Then some food and water."
He grinned and rushed off with the dog. In moments the tub in the bathroom was being filled with water and she could hear her son talking to the dog reassuringly.
Half an hour later son and dog emerged. She studied
He grinned and rushed off with the dog. In moments the tub in the bathroom was being filled with water and she could hear her son talking to the dog reassuringly.
Half an hour later son and dog emerged. She studied
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
the dog who now followed closely behind her son. He was of medium size, bright-eyed...and smiling.
She watched as the dog ate. "Your father had a black dog and he loved that dog a lot. He used to tell me stories about him. Said his name was Jeremy."
He nodded at the dog. "May we keep him?"
She didn't have to give his question much thought. She'd not seen her son this an
She watched as the dog ate. "Your father had a black dog and he loved that dog a lot. He used to tell me stories about him. Said his name was Jeremy."
He nodded at the dog. "May we keep him?"
She didn't have to give his question much thought. She'd not seen her son this an
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
imated in months. "Sure. What are you going to name him?"
Her son paused, then gave his answer. "Buddy."
For the next two days boy and dog were inseparable. They played and worked together. Come bedtime Buddy followed the boy to the bedroom, jumped up on the bed and settled down for the night.
Christmas Eve before the boy fell asleep Buddy squirmed over to him, placed hi
Her son paused, then gave his answer. "Buddy."
For the next two days boy and dog were inseparable. They played and worked together. Come bedtime Buddy followed the boy to the bedroom, jumped up on the bed and settled down for the night.
Christmas Eve before the boy fell asleep Buddy squirmed over to him, placed hi
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
s paws on the boy's shoulders and snuggled up against him. The boy hugged him close and Buddy covered his grinning face with dog kisses. "I love you," he whispered, then fell asleep cradling the black dog in his arms.
Christmas morning the boy woke up to find Buddy gone. He hurriedly changed clothes then ran out of his room, calling after Buddy. He couldn't find Buddy in t
Christmas morning the boy woke up to find Buddy gone. He hurriedly changed clothes then ran out of his room, calling after Buddy. He couldn't find Buddy in t
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
he house so he rushed outside.
There, in the snow were paw tracks. Buddy's. He followed the tracks, calling for the dog...when suddenly the tracks disappeared. He canted his head, "Oh!" he burbled with a giggle. He then took a deep breath. "Oh," he said again as understanding flooded him. He bowed his head and whispered, "Thank you..."
Hearing her son crying out as he hur
There, in the snow were paw tracks. Buddy's. He followed the tracks, calling for the dog...when suddenly the tracks disappeared. He canted his head, "Oh!" he burbled with a giggle. He then took a deep breath. "Oh," he said again as understanding flooded him. He bowed his head and whispered, "Thank you..."
Hearing her son crying out as he hur
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ried through the house she bolted after him. When she caught up to him she glanced down, following the boy's gaze.
She studied the tracks, puzzled. "Where's Buddy? Did you find him?"
The boy reached up and grasped his mother's hand. "I'll tell you when we get inside." With a light tugging he pulled her back in the direction of the house. It had begun to snow. "Let's go, M
She studied the tracks, puzzled. "Where's Buddy? Did you find him?"
The boy reached up and grasped his mother's hand. "I'll tell you when we get inside." With a light tugging he pulled her back in the direction of the house. It had begun to snow. "Let's go, M
.
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
om."
She looked back at the tracks. The snow was quickly filling in the depressions, obscuring the dog's path. She turned back to her son.
He was pulling her faster toward the house. He looked back at her and a bright smile blazed across his face. "I'll race you back." He let go of her hand and dashed across the yard. As he reached the porch he threw his arms over his hea
She looked back at the tracks. The snow was quickly filling in the depressions, obscuring the dog's path. She turned back to her son.
He was pulling her faster toward the house. He looked back at her and a bright smile blazed across his face. "I'll race you back." He let go of her hand and dashed across the yard. As he reached the porch he threw his arms over his hea
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
d and let out a big whoop.
Behind his mother a tall, lanky figure bent down just as a smaller, darker figure ran up to him. "Good, dog, Jeremy. Come on!" The black dog wriggled into the man's arms. "You did good, boy!" The man smiled, and there was a sparkle in his green eyes. He then turned into the swirl of snow, and vanished.
***
Copyright © 2003 by Kathy Pippig Harri
Behind his mother a tall, lanky figure bent down just as a smaller, darker figure ran up to him. "Good, dog, Jeremy. Come on!" The black dog wriggled into the man's arms. "You did good, boy!" The man smiled, and there was a sparkle in his green eyes. He then turned into the swirl of snow, and vanished.
***
Copyright © 2003 by 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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