Chapter 72 Clinical Phase II with Cytotoxicity!
Zhang Yang’s original design idea was very simple.
By changing the covalent bond of the toxic compound "phenprofen" in the finished product "icofenprofovir", it can minimize its toxicity during the first clinical phase.
When it reaches the second clinical phase, he slowly adjusts the effective toxic ingredients to the most reasonable range, and finally becomes a complete product.
In this way, not only can the toxicity test of the first clinical phase be easily avoided, but also the second clinical phase can be passed more easily.
But I didn't expect that Wei Tian would discover it and reveal the hidden toxicity of benzene.
Wei Tian did not notice Zhang Yang’s surprise and said slowly:
“I have been studying the medicine you provided for the past few months.”
"After many trials, I adjusted some drug ingredients and dosages, and finally used them in the previous batch of clinical phase I In the patient test, "Unexpectedly, the normal subjects did not experience any side effects, and all indicators were normal. Only the hepatitis B subjects experienced strong side effects after taking it, such as nausea and vomiting, transaminase, Bilirubin increased rapidly, and obvious acute liver injury occurred. ”
"Fortunately, the side effects of the drug disappeared immediately after stopping the drug."
Hearing this, Zhang Yang has confirmed that this is the way in which the cytotoxicity of "Acofenprofovir" is manifested!
And.
Wei Tian indeed modified the drug ingredients.
At this moment, Wei Tian showed a trace of guilt on his face, and then said:
"However... because of the serious side effects, it attracted the attention of the ethical review committee."
"They now require us to test at the minimum dose and redo the animal experiment immediately..."
"So Mr. Zhang, I'm sorry, but the progress of our first clinical phase may be delayed."
Not only was Zhang Yang not angry, but there was a smile on his face.
Arousing ethical attention is not a big deal, and redoing animal experiments only costs a little time and expense.
Compared to this, Wei Tianneng was a little surprised to discover the poison he had hidden, even...
Surprise!
He knew very well that he understood the cytotoxicity of "Acofenprovir" because he had read the complete answer, and Wei Tian discovered the hidden answer through his own efforts in a pile of fog. toxicity.
Although he made the process easy, discovering the secrets in just three months requires not only a lot of experiments, but also...
A strong and keen mind Pharmacy talent!
He looked at Wei Tian again.
Wei Tian is very young, only twenty-six years old, and his work resume is also very ordinary.
Before coming to Tsingshan Pharmaceutical, he only worked as a drug researcher assistant in one pharmaceutical company. This time he was asked to be responsible for the clinical work of "Acofenprofovir" because of his previous work in "ITG human anabolic hormone". Serious and responsible.
Unexpectedly, after taking charge of his own business, Wei Tian actually showed his talent.
He stood up and patted Wei Tian on the shoulder:
"It's okay. Isn't it just a matter of redoing animal experiments? Isn't it just a toxicity problem?"
"In the next time, I will work with you on research and development to try to solve the toxicity problem as soon as possible!"...
Wei Tian modified the drug ingredients and disrupted Zhang Yang’s plan. In the following time, Zhang Yang fully joined the R&D team and began to participate in the improved research and development of "Acofenprovir".
At this time, he also thought clearly. Since Wei Tiandu had discovered the toxicity of "Icofenprovir", there was no need to hide it anymore and directly adjust the dose of the poison to the standard. dose.
In this way, not only will the subsequent clinical trials be safer, but the safety of the subjects will also be better protected!
Soon, under the leadership of Zhang Yang, the poisonous dose of "Icofenprofovir" was adjusted to the standard dose and determined.
At the same time, while being less toxic to the liver, the inactivation rate of hepatitis B virus has also been further improved.
The improved "Acofenprofovir" began to undergo animal experiments again.
Laboratory experiments generally use white mice for animal experiments, such as testing the toxicity of "Acofenprofovir" to hepatitis B patients. First, a batch of white mice with hepatitis B virus must be cultivated.
However, hepatitis B virus cannot parasitize mice, so the experimental subjects were changed to experimental monkeys.
There is a specialized company that breeds experimental mice and experimental monkeys. After receiving an order from Tsingshan Pharmaceutical, they will infect the experimental monkeys with hepatitis B virus, and then sell the experimental monkeys that have cultivated the virus to Qingshan Pharmaceutical. , thus completing animal experiments.
Compared with the cheap price of white mice, an experimental monkey cultured with hepatitis B virus costs about 250,000 yuan, which is expensive.
Although it was a waste of money, fortunately, half a month later, Qingshan Pharmaceutical and GlaxoSmithKline successfully signed an agency agreement for "ITG human myelopoietin" in the UK. Next, they only need to complete the clinical trial After Phase III trials, “ITG” will be successfully launched in the UK.
At the same time,
With the launch of "ITG human genin" for sale in Southeast Asia, the Southeast Asian market took the lead in setting off a wave of sales.
Gao Qiang of Fuxing Medicine has been laughing so hard lately.
Compared to the poor people in the UK who are still waiting for "ITG" to be launched, many middle class people in European and American countries can't wait to go to the Philippines, Thailand, Vietnam and other places to receive treatment.
No way,
It is too difficult to get a three-month visa for China, while Southeast Asia is visa-free. For this reason, many tour groups in Thailand and the Philippines have even launched special visas for European and American patients. "Medical Tourism".
The three-month tour group can not only cure the disease, but also travel.
This made Gao Qiang itchy, and he wanted to raise the price to US$5,000 a piece.
However, because there is a "price control clause" with Qingshan Pharmaceutical, he can only think about it. If he wants to significantly increase the price, he must get permission from Qingshan Pharmaceutical...
Thinking of Qingshan Pharmaceutical Karma, thinking of Zhang Yang, he suddenly shuddered.
Now that the Southeast Asian market is in full swing, if one day they form an industrial chain, I wonder if Zhang Yang will suddenly kill them hard!
hiss!
It's possible!
Just when Gao Qiang was thinking wildly, with the help of Zhang Yang, "Icofenprofovir" also successfully completed the animal experiment again,
and was used in the next phase of clinical trials. Chuuya passed the toxicity test with difficulty.
However,
When the approval notice for the second phase of clinical trials for "Acofenprovir" came down, Wei Tian not only couldn't laugh, but even felt a little uncomfortable.
Due to the intervention of the ethical review committee, because "icofenprofovir" was exposed to cytotoxicity in the first clinical phase, and because "icofenprofovir" is indeed cytotoxic,
< br>In the clinical phase II announcement, the Ethics Committee clearly required that any recruitment promotional materials for "Icofenprofovir" must be specifically marked with "cytotoxicity".
Moreover, when all subjects sign the clinical trial information form, they must be clearly informed again that there is "unknown" cytotoxicity!
"Cytotoxicity, it is a little difficult to recruit for the second phase of clinical trials..."
Wei Tian sighed heavily.
(End of this chapter)