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How is a drug produced?

Views:51     Author:Site Editor     Publish Time: 2020-12-01      Origin:Site

There are so many different drugs ,with different color /shape ( like capsule ,tablet or Infusion) and price . Here we would like to explain , what makes it so different? How is a drug produced? 


Type of drugs : 

From view of production process : Drugs can be devided to:

1)small molecular drugs , most drugs in the market are small molecular drugs, and most of them are composed by chemical entities , so it is also called chemical drugs 

2) Macromolecular drugs : Are synthesize by cell , which is also called biologics.


From another view of production , a drug can be also called: 

1) Originator drug :which is produced by innovators, no matter it is small molecular drugs or macromolecular drugs . Generally , an originator drug needs a investment of 423 scientists , 6587 clinical test , more than 7million hours and more than one billion USD dollars in average . 

2) Generic drugs : When the patent protection period is expired , the drugs made by others are called Generic drugs .


Producers:  

Top ten pharmaceutical companies in the world: Pfizer  Novartis, Sanofi, Roche Holding, Merk, GlaxoSmithKline, Anjin, AstraZeneca, Lilly, Abbott. 

Best companies related to Oncology: Roche holding, n & Celgene, Novartis, Squibb, Johnson&Johnson, MSD, Pfizer, Lilly, Astrazeneca. 

Famous drug companies in China: Guangzhou Pharm Holding , Xiuzheng Pharma, Shanghai Pharma holding Co.,Ltd ,Harbin Pharmaceutical group holding Co. ect . 


The birth of a drug:

1)Who approves a new drug to the market ? 

In china , it is CFDA : China food and drug administration.

In US: It is US FDA ; In Europe it is EMA , and Japan it is PMDA . US FDA is the most authoritative and powerful organization .They would take with Fast Track , Breakthrough, priority Review and Accelerated approval to speed up the Approval of a drug for the patients sake . 

2)How many new drugs are produced every year ? According to FDA, averagely around 30 new drugs are approved for launching  . Take oncology for example, related data shows from 1999-2013 , FDA approved 50 oncology . In year 2015 , 14 new drugs are approved in cancel field ,takes 31% of all new drugs that year , and 6 in year 2016, which takes 27% of all . Research on Oncology seems the hot spot for recent years study.  

3)How long it takes to produces a new drum ? Generally 15years from concept to a

product for use.

4)How much it cost on a new drug R&D ? Averagely at least one billion . 

5) How many stage for a drum from zero ? Generally speaking , four stages are there .  

1st: Drug discovery ,usually take 5 years . Including : 

a) Basic Research,

b) Target Identification,

c )Target Validation,

d ) Lead Identification,

e ) Lead Optimization。


2nd: Preclinical research , one year .Including  :

a) Literature research,including name of a drug , the rule of nomination etc.

b) Pharmaceutical research,API process research , Prescription and process research, Validation experiments for chemical structure and composition, drum quality research , drafting instruction of drug standard, sample testing , stability experiments of pharmaceutical excipients, Experiments related to packaging containers and materials etc;  

c)pharmacology & Toxicology research : General pharmacology experiments , main pharmacodynamics experiments , Acute Toxicity test , long-term toxicity test , Experimental study on Allergic ,hemolytic and mucosal irritation, Test for mutagemicity , Reproductive toxicity test , carcinogenic toxicity test, dependence test , pharmacokinetics experiments on animals  


3rd: Clinical research : 7 years, there are four stages in Clinical research. 

Stage I : Will take experiments firstly on human , to see whether the drug has critical safety threat on human body . To understand the safety of a drug , drug tolerance and study of pharmacokinetics, provide evidence to design dosage plan ( like how many dosage per time , how many times for day etc ) . Usually will call for 20-100 healthy volunteers . From this stage , scientists will know max dose a human body can take.

Stage II : To check the drug effects , whether it eases the patients'pain. The main task for this stage is to found out a safe and effective dosage, pick out effective drugs and remove useless or high toxic drugs , find out suitable dosage, evaluation on effects. This stage will ask for 100-500 patients for the experiments, take reference group at the same time. 

Stage III : Check the drug tolerance, effects on bigger number of patients, evaluate a drug’s overall risk benefit etc. Experiment patients need is 1000 -5000. Scientists have to provide statistical data on this stage. 

Stage IV :Monitoring the drug after marketing. To monitor the rate of adverse events, drug affects on disease rate and death rate, other affects not included in clinical tests, compare the healing effect on similar chemical compounds, amend operating instruction, take decision to withdraw the drug or not .  


4th: Drugs come to the market.


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