Chapter 1512

"Professor Yang, I've looked at your indicators and the requirements are very low." Wang Xiaoshu brought many experts, all of them frowning.

The establishment of the clinical experimental center of Hedong University was a surprise to the academic circles.

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

Normally speaking, it takes at least three to five years for such a large project to be established and implemented, not counting all the previous time for briefing.

How long did Yang Rui use it?

It's just a few days from the exposure to the establishment.

It is the prestige of Nobel laureate Yang Rui to condense other people's months into days and spend hundreds of thousands of times more money than other scholars.

In fact, there is still a gap between those who returned to China 10 years ago and Yang Rui, who is now spending hundreds of millions of dollars.

Therefore, even if we accept the money from several major banks in the industrial and agricultural construction, even if we can't afford to offend the bank, even if the experts invited by Wang Xiaoshu are still cautious, even if we find obvious loopholes, we still dare not easily question, and the tone of our speech is like discussion.

"We don't think sildenafil's performance is very good..."

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

"Although it is clinical phase II, the curative effect seems to be less significant... Of course, we did not do a complete calculation, but the index is obviously a little low."

Several experts are like students seeking advice. Their weak tone makes Wang Xiaoshu want to hit others.

Fortunately, there is no strict upper and lower level system in academic circles, so what should be said has finally come out.

Although it's not very impressive.

Yang Rui looks more like a student from the appearance. His handsome elder brother smiles, but his words make people want to hit people: "my requirement for sildenafil is not to reduce blood pressure, but mainly to see its mechanism of action. It's a completely different kind of antihypertensive drug, and its mechanism of action is different, We can play different roles for different groups of people. "

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

Anyone with lol after the name of the drug is β Receptor blockers, such as metoprolol, bisoprolol and propranolol, are all of them; The name with dipine is calcium antagonist, the name with pril is angiotensin converting enzyme inhibitor

Taking into account the latest development, there are six major categories of antihypertensive drugs, four of which are the main types. If sildenafil is successful, it is a new type, and its value lies in this.

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

Naturally, it's not easy to achieve better curative effect. Everyone knows that lol, how can you make a happy father? Therefore, most of them are curve saving, finding a different type of goal, so that they can be listed.

Of course, different target types are always useful. There are tens of millions of human beings. It's hard to say which drug is more suitable for them. There's no harm in having more choices.

Different types of antihypertensive drugs, for the majority of patients with hypertension, is excellent.

Having said that, antihypertensive drugs will eventually reduce blood pressure.

Does not depress the blood pressure medicine, give other depressor drugs to boost?

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

Yang Rui coughed twice and said: "from the second stage clinical point of view... No......"

"No... no? Well, ok... What are you going to do? " Professor Jiang Xin will hold back. If he is a student, he will be beaten by the shoe puller now.

With a smile, Yang ruiwu said: "it's true that the preset goal has not been achieved. However, as we all know, the core of clinical trials is phase III. as long as the safety indicators are achieved, the curative effect is not forced to be achieved. We can expand the test population in phase III to see if it can be improved..."

What Yang Rui said is very serious, A few people are not good to interrupt him, listening in silence.

When Yang Rui finished speaking, Wang Xiaoshu asked in Jiang Xin's ear, "is what he said right?"

"In theory, it can be done in clinical stage three." Jiang Xin said, gritting his teeth, said: "the rest is a bunch of nonsense."

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

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

"Shall we go and hear what the doctor says?" Yang Rui led the crowd inside, looking like a tour leader.Subjects can't be contacted directly, so clinicians don't care.

The doctor on duty gave a report to a group of people as soon as he waved.

It's no use.

That's what it's like to do a double-blind experiment, which minimizes the placebo effect.

The so-called placebo effect is a case in which patients feel that they are getting better and then they are really getting better.

Double blind is that patients and doctors don't know whether they get the real medicine or the placebo, which weakens the placebo effect.

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

For example, for common taste problems, clinical experiment centers often like to cover them with strawberry flavor, which shows that strawberry flavor is very suitable for covering up peculiar smell, and it's no harm for younger brothers and sisters who sell expired milk tea to read more books.

"So, the most prominent point of sildenafil at present is that its side effects are very small?" Jiang Xin listened to the clinician's report and couldn't help summing up a sentence.

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

Wang Xiaoshu, who has worked in the bank all his life, recognized the problem of their conversation and asked Jiang Xin in a low voice: "it's useless just because the side effects are small."

"The side effect of starch is also small, it does not cure disease." Jiang Xin sighed in Wang Xiaoshu's ear. He didn't know whether it was intentional or unintentional. His voice was louder, which was heard by several people in front of him.

The clinician first blushed, glanced at Yang Rui, coughed and said, "the most important point of our phase II clinic is still safety... At this point, sildenafil's performance is really good."

"No significant side effects, does not mean good safety." Jiang Xin has no sense of awe for other people. He says a word and peeks at Yang Rui.

Yang Rui felt nothing.

Say sildenafil has no significant side effects? It has side effects. Can you believe it?

However, the side effects of sildenafil are not easy to appear in clinical stage I and II.

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

Others Viagra is really a medicine. Its function is to resist ed, that is, to help men who want to stand up but can't. Of course, it can also help men who can't stand up straight and who can't stand iron enough.

Spring @ medicine is different, it is you want to stand also have to stand, do not want to stand also have to stand, pure punishment station.

To explain with historical stories, Li Shiming, in his later years, met Wu Meiniang. What he needed to show his impulse was Viagra. In her later years, Wu Meiniang summoned the brothers Zhang Yizhi and Zhang changzong. The latter two needed aphrodisiac to show their impulses.

Pfizer's clinical phase I, the subjects are healthy people, and most of them are young people. The men in Pfizer can do a little hard to show respect on weekdays. Whether they eat sildenafil or not, it doesn't make any difference.

This was a big selling point of sildenafil.

It helps you stand up when you want to, and it won't cause misunderstanding when you don't want to. Doesn't this freedom represent the superiority of monetarism? If you have money, you can do whatever you want.

If you're rich, you're Teddy. It's too low.

But also because of this, Pfizer's clinical phase I, also completely did not find the side effects of sildenafil.

In clinical stage II, it's similar.

Clinical phase II focuses on safety and efficacy at the same time, but its most concern is safety. This is the so-called humanitarian new drug development mode. There are usually only 20 to 80 patients in clinical phase I, and its scope is too narrow to comprehensively investigate the safety of drugs.

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

Clinical phase II is the real safety test.

A total of 100 to 300 patients, according to half of the calculation, there are 50 to 150 people will take different doses of drugs.

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 usually choose healthy subjects as much as possible.

Let the 75 year old sick man take part in the test. What's wrong? Who is it?

Therefore, in the second phase of clinical treatment, the patients who take Sildenafil can't stand up straight. After all, there are a few patients who can't stand up straight. It's not very easy for them to meet a suitable target in the efficacy period.In addition, hardening, after all, is somewhat embarrassing. When patients encounter it, they don't necessarily tell the truth.

It should be said that the birth of Viagra, or has a certain dramatic.

In the second phase experiment of clinical experiment center of Hedong University, Yang Rui intentionally increased the probability.

He asked that the selected age group should be more average, that is, the average age should be increased. He also asked that the disease distribution of patients should be more average, that is, the number of serious illness should be increased

In this regard, several specific implementation of the clinicians all admire Yang Rui incomparably.

In their view, this is the example of strict metallurgy.

Put hundreds of millions of dollars of compounds, still do not forget to use the most scientific way to do clinical testing.

On the surface, Jiang Xin is questioning the clinicians, but in fact, he is questioning Yang Rui. In the view of several clinicians, it's too much to question himself and the admirable Professor Yang.

Therefore, Jiang Xin's words about mulberry and locust tree were just exported, and some doctors could not bear to refute them.

Professor Yang's efforts

Professor Yang's preciseness

Professor Yang's seeking truth from facts

Wang Xiaoshu nearly spurted out a mouthful of old blood. Your sister's clinical trial is going to be ruined. How can you be more strict than the standard?

Wang Xiaoshu felt that he had to stand out. This was the accusation given to him by the bank. This was the last moment to protect national wealth and people's property.

"Professor Yang!" Wang Xiaoshu shakes his clothes and shouts with great courage.

"Professor Yang..." a doctor pushed the door in and said in a hurry: "the drug inventory is finished."

When Yang Rui came in, he mentioned it casually. It was a routine task.

Of course, Yang Rui himself is hidden deep meaning, at this time unconsciously smile, ask: "no problem?"

"That..." the doctor faltered and did not answer.

"Let's put it straight. We're here today to listen to the report."

"Sildenafil's finished product... Is missing." The doctor bowed his head, annoyed.

"How could that be?" Yang Rui showed a "shocked" expression. In a flash, he first criticized himself and said, "it's my fault. We shouldn't set up a medicine cabinet in the ward. At that time, the designer reminded me that we Chinese hospitals are used to this. Besides, who can't steal medicine..."

"Yes, how could someone steal medicine!" Several clinicians deal with sildenafil every day, and they all feel strange.

This is the drug in the experiment. It's not sure whether it will kill people. What do you do when you steal it home?

……