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

The establishment of the Clinical Trial Center of Hedong University was actually a bit sudden for the academic community.

So much so that scholars outside Yang Rui's laboratory do not know the specific situation of sildenafil.

Normally, it takes at least three or five years for such a large project to be established and landed, not counting the previous blowing time.

How long did Yang Rui take?

From the revelation of the wind to the establishment, it is just dozens of days.

Condensing other people's months into days, and spending hundreds or thousands of times more money than other scholars, this is the prestige of Nobel laureate Yang Rui.

Speaking of which, there are also bull scholars who returned to China around 10 years ago who have to spend tens of billions of dollars, but there is actually a gap between them and Yang Rui, who is now going to hundreds of millions of dollars.

Therefore, even if they received money from several major banks in the Workers' and Peasants' Construction Middle, even if they couldn't afford to offend the bank, even if it was the experts invited by Wang Xiaoshu, they were still cautious, and even if they found obvious loopholes, they still didn't dare to ask easily, and the tone of their speech was like a discussion.

"We don't think sildenafil is doing very well......"

"Historically, if you're going to get FDA certification, the data isn't enough. ”

"Although it is the second phase of clinical trial, the efficacy still seems to be not very significant...... Of course, we didn't do a full calculation, but the indicators are clearly a bit low. ”

Several experts seemed to be students begging for advice, and their tone was so weak that Wang Xiaoshu wanted to beat someone.

Fortunately, there is no strict hierarchy in the academic world, and what needs to be said is finally spoken.

Although there is no momentum.

Yang Rui looks more like a student from the outside, the handsome college student brother smiled handsomely, but what he said made people want to hit people angrily: "My requirements for sildenafil are not how much blood pressure is lowered, but mainly because of its mechanism of action, which is a completely different antihypertensive drug, its mechanism of action is different, and it can play different roles on different people." ”

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

All drugs with lol after their names are β receptor blockers, such as metoprolol, bisoprolol, and propranolol......

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

According to the new drug marketing requirements of the US FDA, new drugs are either pure new drugs of different types, or sub-new drugs with better efficacy.

If you want to have a better curative effect, it is naturally not easy, everyone Luoer, how can you make a happy daddy, therefore, most of them are curves to save the country, find a different type of target to come out, so as to be listed.

Of course, different target types are always useful, and there are thousands of human beings, and it is not clear which medicine is more suitable for you, and it always hurts to have more choices.

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

That being said, blood pressure medication is meant to lower blood pressure after all.

Do antihypertensive drugs that don't lower blood pressure give other blood pressure medicine to cheer up?

Several scholars looked at each other, and Professor Jiang Xin, who took the lead, asked in a low voice: "Then in terms of the current goal, has it been achieved?"

Yang Rui coughed twice and said truthfully: "Judging from the phase II clinical trial...... There is no ......"

"I didn't ...... Well, okay...... So what are you going to do?" Professor Jiang Xin held back, if it were his student, he would have been beaten by a shoehorn at this time.

Yang Ruiwu smiled and said: "It is true that the preset goals have not been achieved, but as we all know, the core of the clinical trial is the third phase, as long as the safety indicators are reached and the efficacy is not forced, we can expand the test population in the third phase of the clinical trial to see if there can be improvement......

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

It was easy to wait for Yang Rui to finish speaking, Wang Xiaoshu asked in Jiang Xin's ear, "Is what he said appropriate?"

"Theoretically, it is possible to do phase III clinical trials. Jiang Xin gritted his teeth as he spoke, and said, "The rest is all nonsense." ”

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

Unfortunately, there was nothing on site that could control blood pressure.

"Shall we listen to what the doctor has to say?" Yang Rui led everyone inside, looking like he was leading a team to visit.

Subjects cannot be directly contacted, so clinicians don't care.

The doctor on duty waved his hand and gave a report to a group of people.

Nothing to do.

This is the case with double-blind experiments, which minimize the placebo effect.

The so-called placebo effect is a case in which the patient feels that he is getting better, and then he is really better.

Double-blindness means that neither the patient nor the doctor knows whether they are getting the real drug or a placebo, thus weakening the placebo effect.

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

For example, for common taste problems, clinical trial centers often like to cover them with strawberry flavor - this shows that strawberry flavor is very suitable for covering up odors, and it is not harmful for the little brothers and sisters who sell expired milk tea to read more.

"In this way, the most prominent point of sildenafil at present, or are the side effects very small?" Jiang Xin listened to the clinician's report and couldn't help but summarize.

The clinician praised: "That's right, very surprising." We have not found any significant side effects, and the response has been very good after doing the questionnaire. ”

Wang Xiaoshu, who has worked in the bank all his life, heard the problem with the conversation between the two, and asked Jiang Xin in a low voice, "Just the side effects are small, is it useless." ”

"The side effects of starch are also small, and it doesn't cure diseases. Jiang Xin sighed in Wang Xiaoshu's ear, I don't know if it was intentional or unintentional, he spoke a little louder, so that the people in front of him heard it.

The clinician blushed at first, glanced at Yang Rui, coughed, and said as if he hadn't heard: "The point we are most concerned about in the second phase of the clinical trial is still safety...... At this point, sildenafil is doing really well. ”

"The absence of significant side effects does not mean that it is safe. Jiang Xin didn't have any sense of awe for the others, so he took the opportunity to say a word, and then peeked at Yang Rui.

Yang Rui didn't notice anything.

Sildenafil has no significant side effects? This thing has side effects, can you put up a tent or not?

However, the first phase of clinical trials and the second phase of clinical trials are really not easy for sildenafil side effects to appear.

Equating Viagra with an aphrodisiac is a big misconception among ordinary people.

People's Viagra is really a medicine, and its effect is anti-ED, that is, it helps men who want to stand up, but can't stand up. Of course, it can also help men who can't stand up straight and don't stand up iron.

Aphrodisiac @ medicine is different, it is that 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 punishment station.

If you use historical stories to explain, Li Shiming in his later years met Wu Meiniang, and what he needed to show his impulsiveness was viagra. And in her later years, Wu Meiniang summoned Zhang Yizhi and Zhang Changzong brothers, and the latter two needed aphrodisiacs to show their impulses.

In the first phase of Pfizer's clinical trial, the subjects were all healthy people, and most of them were young and middle-aged, and the men in it could be slightly hard to show respect on weekdays, and it made no difference whether they ate sildenafil or not.

This was originally a big selling point for sildenafil.

It helps you stand up when you want to stand up, and it doesn't cause misunderstanding when you don't want to stand up.

If you are rich and you are Teddy, the style is too low.

But because of this, Pfizer's clinical phase I did not find any side effects of sildenafil at all.

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

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

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

The second phase of clinical trial is the real safety test.

For a total of 100 to 300 patients, 50 to 150 people will take different doses of medicines, according to half of them.

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

However, in order to pass the test as much as possible, pharmaceutical companies often select healthier subjects whenever possible.

Let the 75-year-old sick old man participate in the test, what is the problem, who is it?

Therefore, in the second phase of clinical trial, patients who have taken real sildenafil have the problem of not being able to stand up straight, after all, they are a minority, and it is not very easy to meet a suitable object during the effective period.

In addition, this kind of thing is a bit shy after all, and patients may not tell the truth when they encounter it.

It should be said that the birth of Viagra still has a certain drama.

In the second phase of the clinical experiment center of Hedong University, Yang Rui deliberately increased the chance.

He asked for a more even age group to be selected, i.e., to increase the average age, and he also asked for a more even distribution of patients' conditions, i.e., to increase the number of (relatively) serious illnesses......

In this regard, several clinicians who implemented the specific implementation were extremely impressed by Yang Rui.

In their opinion, this is an example of metallurgical rigor.

With hundreds of millions of dollars of compounds, we still don't forget to use the most scientific way to do clinical testing.

Jiang Xin is questioning clinicians on the surface, but he is actually questioning Yang Rui, and in the eyes of several clinicians, it is too much to question himself and the admirable Professor Yang.

Therefore, Jiang Xin pointed out that Sang scolded Huai's words before he came out, and some doctors couldn't bear to refute it.

Professor Yang's efforts......

Professor Yang's rigorous ......

Professor Yang's pragmatic ......

Wang Xiaoshu almost squirted out a mouthful of old blood, your sister, the clinical trial is going to suffer, you are still engaging in ultra-strict standards?

Wang Xiaoshu felt that he had to come out, this was the accusation given to him by the bank, and this was the last moment to protect the country's wealth and protect the people's property.

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

"Professor Yang......" A doctor pushed the door in and hurriedly said, "The medicine inventory is over." ”

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

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

"The ......," the doctor hesitated to answer.

"Let's just say it, everyone is here to listen to the report today. ”

"The finished product of sildenafil...... There is loss. The doctor bowed his head, very annoyed.

"How so. Yang Rui showed a "shocked" expression, and in an instant, he first criticized himself: "It's my fault for this, I shouldn't set up a medicine cabinet in the ward, the designer reminded me at that time, I said that our Chinese hospitals are used to this, besides, who still steals medicine can't ......"

"yes, how could anyone steal medicine!" Several clinicians who deal with sildenafil every day find it incredible.

This is an experimental drug, and it's not sure if it will eat the dead, so what are you going to do when you steal it home?

……

nt

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