Rebirth of the God-level Xueba

What the provincial health standards need to pass is the domestic drug application regulations.

Before 1999, China did not have a national medicine standard, and the approval authority for medicines was in the hands of the provincial medicine supervisory unit.

Compared with the criticized FDA, the difficulty of passing it is like fighting flies and tigers.

Let alone the 70s and 80s, in the 90s, how many doctors of medicine, chemistry, and biology are there in provinces and autonomous regions such as Ning@夏?

Even if there are no doctoral students of the corresponding level, how many undergraduate students can figure out the pharmacokinetics of throwing a medicine out? Needless to say, without double-blind clinical trials to assist in judgment, it originally needed more, more, and more professional knowledge—in fact, it was not enough. Talented doctoral students who have graduated for 10 years and become tenured professors at prestigious universities do not dare to say that they have such judgment.

In the end, whether the drug can be passed or not, whether it can get the provincial health standard, is just a bureaucratic judgment.

In the 1990s, China actually didn't cultivate a few qualified technocrats. Anyway, they just looked at their faces and didn't care about the connotation.

Of course, bureaucratic standards are not necessarily easier than academic standards. However, considering that the number of provincial health standards issued every year, Yang Rui’s medicines are to pass even the stricter Beijing health standards. Easy.

The only thing Yang Rui hesitated was: "This is a new medicine. Something has happened, and it's even bigger than the problem of Law Boding."

The most approved provincial health standards are Chinese patent medicines, and most of them are proven prescriptions, that is, medicines that history proves to be okay. They can also be regarded as passed clinical trials by the people, but the data is not compiled, mortality is easy to control, and side effects are difficult to contact.

In contrast, there are only a few hundred people who have taken the pure new drug sildenafil.

Huang Mao said: "We follow the rules completely... Besides, I think there should be no problem with this medicine."

"Can this be seen?" Yang Rui curled his lips.

"If there is no drug stealing, our Phase II clinical practice will be very smooth, and there will be no problems. The only side effect, now it has been proved that it is not a bad thing." Huang Mao paused, then smiled: "It happens to be it. The effect of lowering blood pressure is not obvious, and there are almost no side effects."

Yang Rui couldn't help laughing.

This is indeed a very funny thing, because sildenafil's blood pressure reduction effect is not obvious, otherwise, using it to make Viagra is still a hassle.

I can’t take the pills. I’m in the hotel, but I fainted because of low blood pressure.

Although sildenafil still has some side effects, especially dizziness and blue eyes, these side effects are pediatrics compared with the potent blood pressure reduction that Pfizer expects.

If the antihypertensive effect is obvious, the application range of sildenafil will be greatly narrowed and become an anti-ED drug only suitable for hypertensive patients.

With such a prefix, it is not easy to sell the blockbuster.

On the contrary, Viagra, an over-the-counter drug with no side effects, can be sold as a sugar pill-selling the drug like a sugar pill. Selling the drug to everyone is the dream of almost all pharmaceutical companies.

For this goal, all clinical tests of sildenafil should be able to withstand scrutiny.

“Phase II clinical trials must be strictly completed before considering whether to apply for domestic drug approval.” Yang Rui made a compromise and explained to Huang Mao: “We only have to announce that domestic testing and domestic sales will be carried out soon. Many people It will be at ease. They just can't wait for a few years, not a few months."

As he said, Yang Rui trembled his eyebrows and smiled: "Isn't it good to give them a few months to find a target?"

Thinking of the role of sildenafil, Huang Mao smiled unkindly.

Indeed, for some long-term difficult households, a few months can still wait.

"But, like this kind of direct call, what should I do?" Huang Mao asked again. People are of a high level, so I don’t really want to wait.

"Just say that our clinical trials are declared to the FDA, and we strictly abide by the principle of openness and transparency. All information of those involved in the test must be reported to the FDA. This, we cannot hide and deceive, and the other party will also There are irregular investigations." Yang Rui paused for a moment, and then said: "When the domestic test starts, we will invite them first."

This reason is worthy of scrutiny.

If Yang Rui doesn't talk about domestic testing, in order to use the medicine a few years in advance, it is really impossible to say whether anyone will ask Yang Rui to ignore the FDA's requirements.

Correspondingly, if the delay is only a few months, the pressure must be much less.

On the other hand, passing the second phase of the clinical test is indeed easy to be reassuring, and it is easier to pass the domestic audit. The so-called sharpening of the knife does not accidentally chop wood.

There are many cases where foreign drugs are sold in the country first, and when they are sold well, they then apply for the US FDA. However, as Yang Rui said, the order needs to be arranged. If there is a scandal, the original The difficult FDA audit has made the situation worse.

"The reason for openness and transparency is good. In this case, all high-ranking officials will be excluded." Huang Mao was relieved. Although he hasn't worked in the system for a long time, the pressure is still indispensable.

Yang Rui nodded and said, "Not only high-level cadres, but middle-level cadres are not allowed. Limit the deputy to below."

"Huh, is this okay?"

"Why not? The health status of cadres is also very important information. Is it right to let foreign institutions obtain it directly?" Yang Rui said, thinking that it made sense to himself, and said: "Give Bo Geng Xin. Call and ask him what is appropriate."

"Good." Huang Mao also cheered up. With such a big hat covered, the trouble will definitely be reduced.

After a while, Huang Mao returned from the office where the telephone line was still plugged in, with a smile on his face, and in a flash, learning to write Geng Xin's expressionless expression, said: "Party members, cadres at the deputy department level and above should not be allowed to participate ~www.NovelMTL.com~ Yes, just click this." Yang Rui immediately decided.

Huang Mao also happily said: "That's good. The direction we are doing now is a bit more special. It's better to have fewer big shots."

"It's less now, and it's indispensable from now on." Yang Rui curled his lips. This is the second phase of the clinical trial. The third phase of the clinical trial has a larger scale and a larger number of people. Even if it is restricted, the domestic drug review will always require concessions.

Only from Yang Rui's point of view, he doesn't really care who will participate in the clinical trial, as long as the second phase has passed, it can be determined that this sildenafil is pisidenafil. I have to say that because of Yang Rui's academic habits, I am afraid that Pfizer will stagger and make a compound with different functional groups and also named sildenafil. Otherwise, if another person appears, he would definitely not be so careful.

However, good academic habits are to be implemented consistently. If you think that a medicine is okay, you are excited to promote it instead of strict double-blind clinical practice. What is the difference between doing traditional Chinese medicine?

Everyone thinks that what they have made is good. Just look at the folk scientists who promote themselves on and off the campus of Peking University. They claim that they have broken the law of conservation of energy and have organized a perpetual motion machine that can be equipped into a group-so much. People who are above Einstein's level, no one thought of building a small high-energy-consuming workshop, step by step upgrade to become a big private boss, and annexing Peking University who only holds the starry sky. It is really... anxious.

Sildenafil is the most concerned drug both domestically and internationally, and procedural justice is always indispensable.

The subjects selected from more than 20,000 people quickly filled the Clinical Experiment Center of Hedong University.

The eyes of all parties come from open, secret, or private betting.

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