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Suggest - The Lord is His Pastor
"No, I don't think you understand me Chief," explained Mike in pigeon English, a blend of English and local dialect. "I am trying to tell you about Jesus and how much he loves you and your people, but
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
you are talking about some real person."
Almost as quickly as the words left his mouth, Mike quickly retracted them; "I don't mean that Jesus is not real, but that you are talking about someone who y
Almost as quickly as the words left his mouth, Mike quickly retracted them; "I don't mean that Jesus is not real, but that you are talking about someone who y
; 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
ou met in person and you can't meet Jesus in person."
Mike's voice trailed off as he realized he had muffed it again. That wasn't what he wanted to say either. Of course Jesus is a real person. Of
Mike's voice trailed off as he realized he had muffed it again. That wasn't what he wanted to say either. Of course Jesus is a real person. Of
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
course you can meet him. He knew what he wanted to say, but this language barrier was proving to be more of a problem than he had anticipated.
Why had he volunteered to come here anyway? Surely the
Why had he volunteered to come here anyway? Surely the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tribe could do without their missionary pastor while he was on a few months furlough. He and the other Bible College students thought they would be having fun in the field during summer vacation. Arg
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
uing with a tribal Chief who always gets his way was not his idea of fun.
But he was deep into it now. Focusing, he tried again. "My friend, I am trying to tell you about the one true God. He lives
But he was deep into it now. Focusing, he tried again. "My friend, I am trying to tell you about the one true God. He lives
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
in a place up there," he said pointing upward, "and he hasn't been here in a long, long time. You simply could not have met him in person."
Obviously frustrated himself, the chief retorted in his ow
Obviously frustrated himself, the chief retorted in his ow
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
blend of English and local language "How God help me if no come village"? Before Mike could answer, the Chief added "Him live here many days. Him give food, teach people, heal sick. Him love my peo
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ple. Him Lord".
"No, no Chief, you don't understand" Mike cried, "whoever you are talking about is not Jesus. Jesus left this world. He is not here. But he promised he will come back one day".
Th
"No, no Chief, you don't understand" Mike cried, "whoever you are talking about is not Jesus. Jesus left this world. He is not here. But he promised he will come back one day".
Th
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
e Chief, with great enthusiasm responded "Ah yes, now you see Chief's point. Jesus come here. Him do all you say. Him leave like you say. But him promise to come back."
Exasperated, Mike said moc
Exasperated, Mike said moc
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ingly, "Okay chief, when? When will he come back?" Certain he had finally prevailed; Mike folded his arms and leaned back on his stool with a grin. But the Chief's response quickly erased the grin a
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
nd almost caused Mike to fall off the stool; "two days Jesus come."
Not knowing how to respond, Mike decided to leave the conversation there and wait for two days to pass. "Then", he thought to himse
Not knowing how to respond, Mike decided to leave the conversation there and wait for two days to pass. "Then", he thought to himse
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
lf, "the Chief will see I was right."
It was barely dawn when the young native shook Mike from sleep "Come, come; Chief say you come? Him say Jesus here." Half asleep and half numbed by the startli
It was barely dawn when the young native shook Mike from sleep "Come, come; Chief say you come? Him say Jesus here." Half asleep and half numbed by the startli
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
ng, unexpected news, Mike hurriedly dressed and ran as fast as his feet could take him to the main camp. His mind raced ahead of his feet as he wondered what on earth this news could mean.
As he came
As he came
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
into the camp, he saw a large group of villagers crowded around the meeting arena. As he pushed his way past the outer ring of the crowd, he saw a tall man towering above the people. Several were pat
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
ting him on the back. Others were hugging him in tears of joy.
Mike couldn't quite make out who the man was until he was almost upon him, but when he did finally recognize him, Mike stopped dead in h
Mike couldn't quite make out who the man was until he was almost upon him, but when he did finally recognize him, Mike stopped dead in h
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
is tracks. There in front of him was the Missionary Pastor. Mike had forgotten that the Pastor's furlough was almost over and that this was the day he was to return.
Immediately, Mike understood. W
Immediately, Mike understood. W
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ile he had been right, it was a hollow victory as the Chief's position had been more accurate and insightful. The Missionary Pastor had set such a perfect Christian example that the people had mistake
.
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
n him for the very Savior he was telling them about.
He had so personified the attributes of Jesus in his service to the villagers that when he spoke about the Lord they could not make a distinction a
He had so personified the attributes of Jesus in his service to the villagers that when he spoke about the Lord they could not make a distinction a
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
nd naturally assumed he was speaking of himself. No doubt the Pastor would correct this misconception when the time was right.
Sometimes the only Jesus people will ever see is us. Win them by exampl
Sometimes the only Jesus people will ever see is us. Win them by exampl
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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