I really don't want to be a doctor
Chapter 492 GCP
Chapter 492 GCP
One morning three days later, Hong Sheng was wearing a very formal white sportswear, standing in Jing Xiaoran's laboratory.
A ray of sunlight shone through the glass onto his face.
"Squad leader, I want to study abroad."
Hong Sheng's voice was not loud, but Jing Xiaoran could hear Hong Sheng's determination from it.
"Have you considered it?" Jing Xiaoran sat on the office chair in the laboratory and looked at the boy in front of him with a smile.
Hong Sheng nodded heavily and said, "En."
"Think about it, this trip will last for three years, and you may not be able to go home a few times."
"Well, I've made up my mind." Hong Sheng said, "My parents also agreed."
"That's good." Jing Xiaoran smiled, "Since you've made your decision, you should hand over your experiment progress to others during this period, and then I'll give you a long vacation so you can prepare materials related to studying abroad. I have already contacted the school in the United States, and I am submitting your information, and I will notify you after the application is approved."
Hong Sheng suddenly stammered: "Squad leader, you...shouldn't object to my going out?"
"Of course not." Jing Xiaoran said with a smile, "Why do you think so? I didn't stop Senior Brother Wang Tuo when he went to take the exam."
"But, isn't this the equivalent of a cooked duck flying?" Hong Sheng whispered, and glanced at Jing Xiaoran after speaking.
"Hey, Hong Sheng, do you ever compare yourself like that?" Jing Xiaoran didn't know whether to laugh or cry, "First of all, where to go is your freedom, as your friend and your old squad leader, I have no right to interfere with your choice; secondly, , this is a once-in-a-lifetime opportunity for everyone. If you can grasp it, you are lucky. Finally, if you go to the United States, I still need your help. This is A choice that has the best of both worlds."
"Ah? What needs my help?" Hong Sheng was at a loss, "Squad leader, please don't misunderstand me."
What Jing Xiaoran can't even do, can he do it?
"Don't be nervous, it's actually a trivial matter. I need you to help me collect some medical records, mainly those of respiratory tract infection." Jing Xiaoran said, "I will send you the specific information when the time comes, after you finish the screening Then just send me the medical records."
"Okay." Hong Sheng nodded.
Although he still doesn't know what it is, since Jing Xiaoran said so, he must try his best to complete it.
Jing Xiaoran also thought about this matter for a long time.
Out of consideration for the future, he needs to make two-handed preparations. In addition to developing his own strength in China, he also needs to contain the disaster from the source if possible.
"Take a good rest during this period." Jing Xiaoran said, "After you go to the United States, you will not be as relaxed as you are now. It may be July at the earliest, and you will be leaving, and it will be less than two months from now .”
"So fast." Hong Sheng's heart tightened, and at the same time, he had a little expectation for his future life.
……
Hong Sheng chose to study in the United States, which was expected by Jing Xiaoran.
It's just that he didn't expect that after the news that Hong Sheng was going to study in the United States spread, not only graduates from Ning'an Medical College wanted to come to Shenzhou Laboratory, but also students from other medical schools in Fancheng came here admiringly.
For a while, the HR of the Shenzhou Laboratory was very busy.
However, Jing Xiaoran's philosophy is to select the best from the best. As for the laboratory's help in studying abroad, not everyone is qualified.
……
After a month.
"Xiao Ran, this is the data of the last batch of experimental patients. Our clinical experimental team conducted a simple analysis of all the laboratory data in advance. From the perspective of the curative effect of only one year, the patients in respiratory tract tumors, gastrointestinal tract tumors, and blood On systemic tumors, our immune checkpoint inhibitors have higher survival than other conventional chemotherapy methods!"
Zhu Xianqing collected all the experimental results of this year in the USB flash drive.
In clinical trials, apart from the Radiation Laboratory program, the most difficult one is the analysis of clinical data.
How to solve a series of numbers into meaningful clinical experiment results is the role of statistics.
The USB flash drive in his hand is very small, but Jing Xiaoran felt that it weighed heavily as he held it.
For the birth of a new drug, it takes at least seven or eight years from the discovery of the compound to its successful marketing.
The immune checkpoint compound was discovered by scientists in the 80s, and it has been almost 30 years since it was successfully developed into a drug.
In the five years after Jing Xiaoran's rebirth, most of the time was spent on research and development of immune checkpoint inhibitors.
Today, their efforts are bearing fruit!
"Mr. Zhu, do you know how is the progress of the experiment at AstraZeneca?" Jing Xiaoran suddenly looked at Zhu Xianqing nervously.
Zhu Xianqing grinned and said, "They still have a lot of experiments to do, this time, we are ahead of them."
Just like that, on a sunny afternoon, Jing Xiaoran and Zhu Xianqing sat opposite each other in the Shenzhou Laboratory.
They looked at each other and smiled, and jointly announced the success of the immune checkpoint inhibitor.
Jing Xiaoran had thought many times that on the day the clinical experiment ended, maybe he would cry with joy.
But not as excited as imagined, Jing Xiaoran suppressed his inner joy.
Because he knows that the current clinical trials can only be regarded as more than half completed. In the last step, in addition to writing relevant medical papers, they also need to apply to the China Food and Drug Administration (GCP) for drug production and marketing.
This step is considered a finishing touch. The steps are simple, but extremely important.
There are many new drugs that are stuck in this link every year, resulting in delays in the production and marketing of drugs.
In addition, if the drug of Shenzhou Lab wants to be marketed in the United States, it also needs to apply for FDA certification.
"Xiao Ran, I'll take care of the rest of the experimental papers." Zhu Xianqing said, "However, you may need to come in person to apply for GCP and FDA certification."
"Okay." Jing Xiaoran understood Zhu Xianqing's meaning.
Generally speaking, the certification of Huaxia GCP also takes more than half a year.
GCP will conduct a very strict review on the units or individuals involved in the research, production, operation, use, inspection, supervision and approval management of new drugs.
And he has a lot of contacts in the medical system. If he can come forward to apply for GCP, it may be able to get twice the result with half the effort and shorten the review time.
……
Regarding the approval and reporting of new drugs, Jing Xiaoran first thought of Zang Hongfeng.
He is Jing Xiaoran, who has the best relationship and the highest official position in the medical government system.
"Xiao Ran, your experiment was completed so soon?" Zang Hongfeng still couldn't believe it when he received a call from Jing Xiaoran.
Just a year in, clinical trials of immune checkpoint inhibitors over?
(End of this chapter)
One morning three days later, Hong Sheng was wearing a very formal white sportswear, standing in Jing Xiaoran's laboratory.
A ray of sunlight shone through the glass onto his face.
"Squad leader, I want to study abroad."
Hong Sheng's voice was not loud, but Jing Xiaoran could hear Hong Sheng's determination from it.
"Have you considered it?" Jing Xiaoran sat on the office chair in the laboratory and looked at the boy in front of him with a smile.
Hong Sheng nodded heavily and said, "En."
"Think about it, this trip will last for three years, and you may not be able to go home a few times."
"Well, I've made up my mind." Hong Sheng said, "My parents also agreed."
"That's good." Jing Xiaoran smiled, "Since you've made your decision, you should hand over your experiment progress to others during this period, and then I'll give you a long vacation so you can prepare materials related to studying abroad. I have already contacted the school in the United States, and I am submitting your information, and I will notify you after the application is approved."
Hong Sheng suddenly stammered: "Squad leader, you...shouldn't object to my going out?"
"Of course not." Jing Xiaoran said with a smile, "Why do you think so? I didn't stop Senior Brother Wang Tuo when he went to take the exam."
"But, isn't this the equivalent of a cooked duck flying?" Hong Sheng whispered, and glanced at Jing Xiaoran after speaking.
"Hey, Hong Sheng, do you ever compare yourself like that?" Jing Xiaoran didn't know whether to laugh or cry, "First of all, where to go is your freedom, as your friend and your old squad leader, I have no right to interfere with your choice; secondly, , this is a once-in-a-lifetime opportunity for everyone. If you can grasp it, you are lucky. Finally, if you go to the United States, I still need your help. This is A choice that has the best of both worlds."
"Ah? What needs my help?" Hong Sheng was at a loss, "Squad leader, please don't misunderstand me."
What Jing Xiaoran can't even do, can he do it?
"Don't be nervous, it's actually a trivial matter. I need you to help me collect some medical records, mainly those of respiratory tract infection." Jing Xiaoran said, "I will send you the specific information when the time comes, after you finish the screening Then just send me the medical records."
"Okay." Hong Sheng nodded.
Although he still doesn't know what it is, since Jing Xiaoran said so, he must try his best to complete it.
Jing Xiaoran also thought about this matter for a long time.
Out of consideration for the future, he needs to make two-handed preparations. In addition to developing his own strength in China, he also needs to contain the disaster from the source if possible.
"Take a good rest during this period." Jing Xiaoran said, "After you go to the United States, you will not be as relaxed as you are now. It may be July at the earliest, and you will be leaving, and it will be less than two months from now .”
"So fast." Hong Sheng's heart tightened, and at the same time, he had a little expectation for his future life.
……
Hong Sheng chose to study in the United States, which was expected by Jing Xiaoran.
It's just that he didn't expect that after the news that Hong Sheng was going to study in the United States spread, not only graduates from Ning'an Medical College wanted to come to Shenzhou Laboratory, but also students from other medical schools in Fancheng came here admiringly.
For a while, the HR of the Shenzhou Laboratory was very busy.
However, Jing Xiaoran's philosophy is to select the best from the best. As for the laboratory's help in studying abroad, not everyone is qualified.
……
After a month.
"Xiao Ran, this is the data of the last batch of experimental patients. Our clinical experimental team conducted a simple analysis of all the laboratory data in advance. From the perspective of the curative effect of only one year, the patients in respiratory tract tumors, gastrointestinal tract tumors, and blood On systemic tumors, our immune checkpoint inhibitors have higher survival than other conventional chemotherapy methods!"
Zhu Xianqing collected all the experimental results of this year in the USB flash drive.
In clinical trials, apart from the Radiation Laboratory program, the most difficult one is the analysis of clinical data.
How to solve a series of numbers into meaningful clinical experiment results is the role of statistics.
The USB flash drive in his hand is very small, but Jing Xiaoran felt that it weighed heavily as he held it.
For the birth of a new drug, it takes at least seven or eight years from the discovery of the compound to its successful marketing.
The immune checkpoint compound was discovered by scientists in the 80s, and it has been almost 30 years since it was successfully developed into a drug.
In the five years after Jing Xiaoran's rebirth, most of the time was spent on research and development of immune checkpoint inhibitors.
Today, their efforts are bearing fruit!
"Mr. Zhu, do you know how is the progress of the experiment at AstraZeneca?" Jing Xiaoran suddenly looked at Zhu Xianqing nervously.
Zhu Xianqing grinned and said, "They still have a lot of experiments to do, this time, we are ahead of them."
Just like that, on a sunny afternoon, Jing Xiaoran and Zhu Xianqing sat opposite each other in the Shenzhou Laboratory.
They looked at each other and smiled, and jointly announced the success of the immune checkpoint inhibitor.
Jing Xiaoran had thought many times that on the day the clinical experiment ended, maybe he would cry with joy.
But not as excited as imagined, Jing Xiaoran suppressed his inner joy.
Because he knows that the current clinical trials can only be regarded as more than half completed. In the last step, in addition to writing relevant medical papers, they also need to apply to the China Food and Drug Administration (GCP) for drug production and marketing.
This step is considered a finishing touch. The steps are simple, but extremely important.
There are many new drugs that are stuck in this link every year, resulting in delays in the production and marketing of drugs.
In addition, if the drug of Shenzhou Lab wants to be marketed in the United States, it also needs to apply for FDA certification.
"Xiao Ran, I'll take care of the rest of the experimental papers." Zhu Xianqing said, "However, you may need to come in person to apply for GCP and FDA certification."
"Okay." Jing Xiaoran understood Zhu Xianqing's meaning.
Generally speaking, the certification of Huaxia GCP also takes more than half a year.
GCP will conduct a very strict review on the units or individuals involved in the research, production, operation, use, inspection, supervision and approval management of new drugs.
And he has a lot of contacts in the medical system. If he can come forward to apply for GCP, it may be able to get twice the result with half the effort and shorten the review time.
……
Regarding the approval and reporting of new drugs, Jing Xiaoran first thought of Zang Hongfeng.
He is Jing Xiaoran, who has the best relationship and the highest official position in the medical government system.
"Xiao Ran, your experiment was completed so soon?" Zang Hongfeng still couldn't believe it when he received a call from Jing Xiaoran.
Just a year in, clinical trials of immune checkpoint inhibitors over?
(End of this chapter)
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