Chapter 500

Yang Xiaotian called his teacher at Stanford, Caroline ska.

Caroline ska was very surprised and asked, "sky, what can I do for you?"

"Teacher, I really have something to do with you this time. I have developed a new drug here. I want to ask about the FDA's certification!" Yang Xiaotian said.

"Oh, new drug, you're amazing. I knew you were the best of my students! But it's not supposed to be researchers, is it? " Carolinska first praised Yang Xiaotian, and then said.

Her implication is that researchers should only research and develop drugs, and there should be special administrative personnel to do things like registration and FDA.

Yang Xiaotian slightly embarrassed said: "teacher, in fact, this drug is my own development!"

"Oh, my God!" Carolinska exclaimed, "but personally, the price is too high! Not to mention anything else, we have to find thousands of people to do clinical tests in the third phase of clinical trials, which is a huge expense! "

"Yes, I know, and it's still Chinese patent medicine. It seems more difficult!" Yang Xiaotian said.

What he said was the difficulty of clinical testing.

According to the requirements of Western medicine, each single component in the drug requires 600 people to do the clinical phase III double-blind experiment.

Three hundred of them took medicine, and the other three hundred were the control group.

Western medicine is a chemical, so each single component can be well tested.

But traditional Chinese medicine is a finished product.

Each finished product contains many single components.

For example, ginseng contains 37 kinds of saponins, each of which is a single component. This requires more than 20000 people. In addition, there are also polysaccharides and proteins. These are simply 10 kinds of saponins, and there are more than 10000 people.

That's important. Can't you just add ginseng?

Add some Poria cocos.

There are more than 20 kinds of polysaccharides in Poria cocos, more than 10000 people, more than 40 kinds of terpenoids, more than 20000 people, more than 10 kinds of sterols, more than 10000 people.

Let's conduct a clinical trial on a traditional Chinese medicine according to this clinical trial method.

Take Sijunzi Decoction, the most classic drug with only four ingredients, as a clinical trial, which also needs 300000 or 400000 clinical trials and corresponding funds.

Because of this, many side effects of Chinese patent medicines are written as "not clear". This is not irresponsible, but there is really no way.

But this is not to say that Chinese medicine is made in a crude way. There are a series of regulations on the management of Chinese medicine in China, such as the "quality management standard for the production of Chinese herbal medicine", "quality management standard for the production of drugs", "quality management standard for non clinical research of drugs", "quality management standard for drug business", "Chinese Pharmacopoeia", "drug standards issued by the Ministry", etc.

The production and delivery of any traditional Chinese medicine must comply with these requirements.

In the final analysis, traditional Chinese medicine and Western medicine are not the same thing.

Every single molecule of Western medicine is definite and traceable.

Traditional Chinese medicine is processed with ready-made products (such as ginseng, angelica, etc.), each ready-made product has many single molecules.

And even if you have a lot of willpower and money to find more than 400000 people for clinical trials.

I can't either.

Because of the ready-made products, ginseng, it is planted.

This year's good, next year's bad.

There are also changes in the contents.

Is it necessary to organize more than 400000 people to do clinical trials every year?

So it's not the same thing at all. You have to let traditional Chinese medicine follow the standard of Western medicine. How can you do that? With what?

It's like boxing and Sanda. How do you say to fight? Who uses whose rules?

Let's take a more extreme example. Those boxing techniques that specialize in the lower three routes, such as puckering and lying on the floor, go to fight with boxers and follow whose rules?

However, Karolinska laughed when she heard that Yang Xiaotian was making traditional Chinese medicine and said, "sky, if you want to sell it in the United States, I suggest you not sell Chinese patent medicine, which is the kind of good medicine, such as Simotang. Yes, I know that Xiaoshi is very good! But in America, you really can't sell it! But I suggest you open a drugstore! "

"Drugstore?" Yang Xiaotian doubts a way, "teacher, is drugstore useful?"

"Of course, you've been studying in America for so long, haven't you been to Chinatown? No, not to mention Chinatown, Chinese medicine shops can be seen everywhere in many places where Chinese people gather Said carolinska.

"Well, I haven't paid much attention to it, teacher. Can you tell me more about it?" Yang Xiaotian asked.

"That's it Caroline ska explained, "it's very difficult for traditional Chinese medicine to pass FDA certification, but it can be sold as a video or nutritional supplement. This method is allowed by FDA!"

"So, teacher, do you mean to sell health care products?" Yang Xiaotian asked.

"No, no, that's another category. In fact, it's food!" Said carolinska.

"Food?"

"Yes! To be exact, it's the ingredients! You sell traditional Chinese medicine as food instead of medicine, so there is no obstacle! " Said carolinska.

"Is that really OK?"

"Absolutely no problem, we all sell like this! For example, I go to buy Astragalus, I go to buy Angelica! I just want to eat. Can you say this plant can't be eaten? " Asked Caroline ska.

"Er..." Yang Xiaotian said nothing.

"So, if you're in the United States, you can only sell traditional Chinese medicine, as long as you don't extract, concentrate, or use it as an injection, you can't count it as a medicine," carolinska said! It's just food! But then again, my dear young man, what kind of medicine have you developed? "

"Medicine for cerebral palsy!" For his teacher, Yang Xiaotian did not hide anything.

"Oh?" Caroline ska's voice was filled with surprise. "What's the effect?"

"We haven't found a patient to do the experiment, but we can know from the animal experiment that the effect is still good!" Yang Xiaotian some proud said.

"Ha, well done. Come to California sometime. There are some children with cerebral palsy in our affiliated hospital. They are very pitiful. If it really works, they don't care whether it's medicine or witchcraft!" Carolinska said with a smile.

"Teacher, Chinese medicine is the wisdom of the sages, not witchcraft!" Yang Xiaotian stressed.

"Ha ha, look, my good boy is angry!" Caroline ska laughed. "But I'd like you to come as soon as possible."

"OK, I'll be there soon!" Yang Xiaotian nodded.

After hanging up the phone, Yang Xiaotian felt his chin and began to think, is it a good idea to open a drugstore in the United States?

But if it's just selling drugs to treat cerebral palsy, isn't it too little?

By the way, how about selling some traditional Chinese medicine?

It seems that we need to find some traditional Chinese medicine in the past?

But these are not urgent. Let's go to the United States first.

But before that, it's important to go to the fishing port first.

The main purpose of going to the fishing port is to register a new company. Although it's back, it's still one country, two systems. It's relatively convenient to register a new company there.

It's five hundred chapters before I know it