"Professor Yang, I looked at your indicators and the requirements are very low." Wang Xiaoshu brought a number of experts, all frowned.

The establishment of the Clinical Experiment Center of Hadong University was actually a bit sudden to the academic community.

Even scholars outside of Yang Rui's laboratory did not know the specific situation of sildenafil.

Normally, for such a large project, it will take at least three to five years from the initiation to the implementation of the project, not counting the various air time before.

How long did Yang Rui use it?

It took dozens of days from the time the wind was heard to the establishment.

Condensing other people's months into sky, the money spent is hundreds to thousands of times that of other scholars. This is the prestige and prestige of Nobel laureate Yang Rui.

Speaking of it, some of the big cattle scholars who returned to China around 10 years ago also needed tens of billions of dollars in funding, but there is still a gap between that and Yang Rui, who now needs hundreds of millions of dollars in funding.

Therefore, even if they received money from several major industrial and agricultural construction banks, even if they could not offend the bank, even if it was the experts invited by Wang Xiaoshu, several of them were still cautious. Even if they found obvious loopholes, they still did not dare to question and speak His tone is also like a discussion.

"We don't think the performance of sildenafil is too good..."

"Historically, if you want to pass the US FDA certification, the data may not be enough."

"Although it is the second phase of the clinical trial, the curative effect seems to be not very significant...Of course, we have not done a complete calculation, but the indicators are obviously somewhat low."

Several experts looked like students asking for advice, and their voices were so weak that Wang Xiaoshu wanted to hit someone.

Fortunately, academia does not have a strict system of superiors and subordinates, so what should be said is finally said.

Although there is not much momentum.

Yang Rui looks more like a student from the outside. The handsome college student smiled handsomely, but what he said made people annoyingly want to hit someone: "My requirement for sildenafil is not how much blood pressure is lowered. The main thing is to fancy. Its mechanism of action is a completely different antihypertensive drug. Its mechanism of action is different, and it can exert different effects on different groups of people."

The classification of antihypertensive drugs is based on the mechanism of action.

Anything with Lolol after the name of the drug is a beta-blocker. Metoprolol, bisoprolol, and propranolol are all of this type; those with dipine in the name are calcium antagonists, and the name is with Puri's is an angiotensin-converting enzyme inhibitor...

Counting the latest developments, there are six major categories of antihypertensive drugs. The main force is four of them. If sildenafil is successful, it will be a new type, and its value lies in this.

According to the US FDA's new drug listing requirements, new drugs are either pure new drugs of different types or sub-new drugs with better curative effects.

It is naturally not easy to have a better curative effect. Everyone is Lor. Why can you make a happy father? Therefore, most of them are curved to save the country. Find a different type of target to get listed.

Of course, different target types are always useful. There are thousands of human beings, and they are not sure which medicine is more suitable for them. There is always no harm in choosing more options.

The completely different types of antihypertensive drugs are even better for the majority of hypertensive patients.

Having said that, antihypertensive drugs are to lower blood pressure after all.

Will antihypertensive drugs that do not lower blood pressure help other antihypertensive drugs?

Several scholars looked at each other, and the lead Professor Jiang Xin asked in a low voice: "So in terms of the current goal, have you achieved it?"

Yang Rui coughed and coughed, and said: "From the perspective of Phase II clinical trials...no..."

"No...no? Well, okay...what are you going to do?" Professor Jiang Xin will hold back. If his students were already hit by shoehorns.

Yang Ruiwu smiled and said: "It is true that the pre-set goal has not been achieved. However, as everyone knows, the core of clinical trials is Phase III. As long as the safety indicators are met, the efficacy is not mandatory. We can achieve clinical trials in Phase III. At that time, expand the subject population to see if there is any improvement..."

What Yang Rui said was really serious, and a few people couldn't interrupt him, so they listened silently.

After Yang Rui finished speaking, Wang Xiaoshu asked in Jiang Xin's ear: "Is he right?"

"Theoretically, it can be clinical phase III." Jiang Xin gritted his teeth and said: "The rest is nonsense."

Wang Xiaoshu suddenly felt that his blood pressure could not be controlled again.

Unfortunately, there was nothing to control blood pressure at the scene.

"Why don't we go and listen to what the doctor says?" Yang Rui led the crowd inside, as if leading a team to visit.

The subject cannot be directly touched, so the clinician doesn't care.

The doctor on duty gave a report to a group of people while waving his hands.

There is no use for eggs.

This is the case with a double-blind experiment, which minimizes the placebo effect.

The so-called placebo effect is a case where the patient feels that he is almost healed, and then he is really healed.

Double-blind means that neither the patient nor the doctor knows whether they have received (issued) the real medicine or a placebo, thus weakening the effect of the placebo.

Of course, for some drugs with obvious side effects, it is more difficult to hide the placebo effect.

For example, for common taste problems, clinical experiment centers often like to use strawberry flavor to cover up-this shows that strawberry flavor is very suitable to cover up the peculiar smell, and the younger brothers and sisters who sell expired milk tea do not hurt to read more.

"In that case, the most prominent point of sildenafil is still the side effect is very small?" Jiang Xin listened to the report of the clinician and couldn't help but sum up.

The clinician praised: "Yes, it's a very surprising performance. We haven't found any obvious side effects. After doing a questionnaire survey, the response is also very good."

Wang Xiaoshu, who has worked in the bank all his life, heard the problems in the conversation between the two and asked Jiang Xin in a low voice, "Is it useless if the side effects are small."

"The side effects of starch are also small. It doesn't cure the disease." Jiang Xin sighed in Wang Xiaoshu's ear, not knowing whether it was intentional or unintentional. The voice was louder, so that several people before him could hear it.

The clinician blushed first, glanced at Yang Rui, coughed, and said as if he hadn't heard: "The most important point of our Phase II clinical trial is still safety... At this point, the performance of sildenafil is It's really good."

"There are no significant side effects, it does not mean that the safety is good." Jiang Xin no longer feels awe of other people, took the opportunity to say something, and then took a peek at Yang Rui.

Yang Rui felt nothing.

Say sildenafil has no significant side effects? This thing has side effects, can you put up a tent, do you believe it?

However, it is really not easy to show the side effects of sildenafil in clinical phase I and clinical phase II.

It is a big misunderstanding of ordinary people to equate Viagra with an aphrodisiac.

People's Viagra is really medicine. Its function is to resist ED, which is to help men who want to stand up but can't stand up. Of course, it can also help men who can't stand straight or who don't have enough iron.

[email protected]药 is different. It means you have to stand if you want to stand, and you have to stand if you don’t want to stand. It is purely a penalty.

To explain with historical stories, Li Shiming in his later years met Wu Meiniang. To express his impulse, all he needed was Viagra. But Wu Meiniang, who was in her later years, summoned Zhang Yizhi and Zhang Changzong brothers. The latter two wanted to show their impulse, and all they needed was an aphrodisiac.

In Pfizer's first clinical phase, the subjects were all healthy people, and most of them were young adults. The men in it were able to show respect by being slightly hardened on weekdays. In fact, there is no difference between eating sildenafil or not. .

This was originally a major selling point of sildenafil.

It helps you stand up when you want to stand up, and does not cause misunderstandings when you don't want to stand up. Does this freedom represent the superiority of moneyism? If you have money, you can do whatever you want.

It's Teddy if it's rich, and the style is too low.

But also because of this, Pfizer's first phase of clinical practice did not find the side effects of sildenafil at all.

In the second phase of the clinical trial, the situation is similar.

The second clinical phase is said to focus on safety and efficacy at the same time, but it is most concerned about safety. This is the so-called humanitarian new drug development model. The first clinical phase usually has only 20 to 80 subjects. The scope is too narrow, and it is difficult to comprehensively examine the safety of drugs.

It can be said that the main purpose of the first clinical phase is to investigate the general toxicity to humans-the general toxicity to animals has been screened through animal experiments.

The second clinical phase is the real safety test.

A total of 100 to 300 patients, calculated as half, there are 50 to 150 patients who will take different doses of medicine.

Most of the side effects will be found in this phase of testing.

However, in order to pass the test as much as possible, pharmaceutical companies usually choose healthier subjects as much as possible.

Let the 75-year-old sick man take the test, what is wrong, who is it?

Therefore, in the second phase of the clinical trial, patients who took real sildenafil had problems with standing upright. After all, it was a minority, and they had to meet a hard target during the drug's validity period. It's easy.

In addition, hardening is a bit embarrassing after all, and patients may not tell the truth when they encounter it.

It should be said that the birth of Viagra is still somewhat dramatic.

In the second phase experiment of the Clinical Experiment Center of Hedong University, Yang Rui deliberately increased the probability.

He requested that the selected age group be more even, that is, the average age has been increased, and he also requested that the distribution of the patients' conditions be more even, that is, the number of (relatively) serious illnesses should be increased...

Regarding this, several clinicians who implemented it were very impressed with Yang Rui.

In their view, this is an example of rigorous learning.

With hundreds of millions of dollars worth of compounds, I still don't forget to use the most scientific method for clinical testing.

On the surface, Jiang Xin is questioning the clinician, but he is actually questioning Yang Rui~lightnovelpub.net~. In the eyes of several clinicians, it is okay to question himself, and it is too much to question the admirable Professor Yang.

Therefore, Jiang Xin said that Sang cursed Huai, and some doctors couldn't bear to refute it.

Professor Yang’s efforts...

Professor Yang's rigor...

Professor Yang's seeking truth from facts...

Wang Xiaoshu almost spit out a mouthful of old blood. Your sister's clinical trials are going to suffer, but you are still rigorous beyond the standard?

Wang Xiaoshu felt that he had to get ahead. This is the accusation given to him by the bank. This is the last moment to protect the wealth of the country and the property of the people.

"Professor Yang!" Wang Xiaoshu shook his clothes and shouted with a fearless spirit.

"Professor Yang..." A doctor opened the door and hurriedly said: "The inventory of medicines is finished."

The inventory of medicines was mentioned by Yang Rui casually when he came in. It was a routine task.

Of course, Yang Rui himself was hiding his deep meaning. At this time, he smiled unconsciously and asked, "No problem, right?"

"That..." The doctor hesitated without answering.

"Just say it, everyone is here to listen to the report today."

"The finished product of sildenafil... is missing." The doctor lowered his head, very annoyed.

"How could this be?" Yang Rui showed a "shocked" expression. In a flash, he criticized himself first: "This is to blame. I shouldn't set up a medicine cabinet in the ward. The designer reminded me at that time. I said that all Chinese hospitals are used to it. That's it, let's talk about it, who can't steal the medicine..."

"Yeah, how could anyone steal the medicine!" Several clinicians deal with sildenafil every day, feeling incredible.

This is the medicine in the experiment. I'm not sure if it will kill people. What do you steal home and do?

...

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