How difficult is the clinical study of children's medicine? What categories are suitable for clinical data for OR?

 

  Recently CDE issued a notice on the Opinions of the Opinions of the Opinions of the Opinions of the Principles of Adult Drug Data Data Polynesia and Related Information for Pharmaceuticals Pharmaceuticals and Related Information。Its purpose is to encourage the development of children's medicine，Guarantee for children with children for children，Reduce unnecessary unnecessary pediatric human clinical trial research，Scientific use of data from existing adult medications，Systemic integration through adult medication data、Qualitative data assessment、Quantitative Evidence Comprehensive、PK/PD model、End point and other extra -push methods，Perfect and rich drug manual information in the pediatrics in the drug manual，Guidance Pediatric Clinical Medicine。

 

  Shi Min Information Analysis of the Clinical Test Registration of CDE Drugs and Information Publication Platform released by my country found that the number of drug clinical trials related to children'stake betting apps indications has remained at the level of about 20 cases since 2014; the clinical clinical announced in 2013 The current status in the registration number is & ldquo;，Recruitment & rdquo;，This situation is relatively good in 2014，Only 16%are in & ldquo;，Recruitment & rdquo; Status，59%of the case in 2015 is still in & ldquo;，Recruitment & rdquo; Status。

 

 

  Vaccine & mdash; & mdash; Pediatric clinical research No.1

 

  In the clinical registration number related to children's indications from 2013 to the present,，29%is from the vaccine。For the vaccine for patients with pediatric patients，27%of the vaccine is mainly related to spinal cord inflammation，21%related to pneumonia。

 

 

  Cordyllaritis (spinal ash) is a serum type (Ⅰ、Ⅱ、Type III) Spinal ash virus (Poliovirus，PV) any of the acute intestinal infectious disease caused by any kind of acute intestinal infectious disease。Oral poisoning vaccine (Oral Poliomyelitis Attenuated Live Vaccine，OPV) The intestinal tract and the whole body can produce a protective immune response。In September 2016 CFDA's approval drugs，There is a spinal cord iconic inflammation of the Institute of Medicine and Biology of the Chinese Academy of Medical Sciences.，Used to prevent spinal ash，It can stimulate the body to produce anti -gryomitis virus immunity。

 

  Data Extreme Policies: Good chemicals

 

  Anemia is one of the main clinical research directions of pediatric chemical drugs。Sodium sodium oral liquid in the ground is used to treat patients with iron deficiency anemia children、Pregnant women who cannot withstand other oral forms of iron，and anemia caused by rheumatoid arthritis。Earth Laros (Ergg) is treated under 6 years old & beta;。Injecting sodium sodium folic acid and sodium folic acid injections is used to oral diarrhea when orally oral folic acid is not effective、Nutrition、Giant cellular anemia caused by pregnancy or infantile period，but not applicable to vitamin B12 deficiency anemia。

 

  Although the indication stake betting appof Zuo Yirais Tablets and Zuo Yiraistein's alternative tablets is an additional treatment for adults and patients with epilepsy for adults and children over 4 years old，But after careful analysis of clinical registration information，Basic all biological equivalent test solutions are designed for patients over 18 years old，The design of the original medicine is over 16 years old，No corresponding child test design part，The indication of the declaration is just referring to the indication of the original drugs that have been listed abroad。

 

  The phenomenon used by the global pediatric drug super instructions is very common，The main reasons include the number of children less than adults、There is a unique ethical challenge in the child to carry out clinical trials、Research needs to provide special protection for children。These reasons make it more difficult to carry out pediatric clinical trials than adult research。So，It is difficult to obtain research data from children with large -scale confirmation clinical trials，Support it for the safety and effectiveness of each specific age stage。

 

  On the other hand，Consider ethics，Using new technologies and establishing new methods，Reduce unnecessary clinical trials of pediatric population drugs，It is conducive to minimizing the pain of the pediatric group。minimize the number of subjects in the clinical trials of pediatrics as much as possible，Utilize existing data to the greatest extent，Extracting and rich pediatric medication information through data，Guiding clinical medication，It has become an important and necessary way to ensure the safety of medication for pediatric patients。In view of this，Zuo Yirais Tablets and Zuo Yitan Tunse Caps are not designed with clinical trials of 4 to 18 years old.，After all, it is derived from foreign pediatric data，It is also the direction that the industry is more Stake Sports Bettingrecognized in recent years。

 

  Foreign pediatric data derivation to our pediatrics is mainly through the principle of external push，Pediatric drugs that will be listed in Europe and the United States and neighboring countries，or the approved indications pushed to the pediatric group of our country，Reduce unnecessary repeated research in patients with pediatrics in my country。"Principles of the Technical Guidance Principles of the Pediatrics of Pediatrics Pharmaceuticals and Related Information (Draft for Comment)" will accelerate the introduction of pediatric drugs listed in Europe and the United States and neighboring countries in my country。

 

  It is worth noting is，Data of drug clinical trials of pediatric people abroad，does not mean that it does not need to conduct clinical trial research，Instead, clinical trials are studied between adult patients: first evaluate disease epidemic diseases in different countries or regions、Cause、Is there any difference in the prognosis of pathogenesis and the progress of the disease; on this basis，Evaluate the test data of adult patients at home and abroad，Focus on evaluation of race differences，Including whether there are clinical pharmacology and therapy (medical practice、Data of security validity) and other aspects，If there is sufficient evidence in the comparison of the above aspects, there is no significant difference，It can follow the clinical trial data of the drugs of foreign pediatrics.。

 

  Chinese Pharmaceutical Research: Mainly breathing and gastrointestinal diseases

 

  Chinese patent medicine，A total of 17 Chinese medicine products 22 acceptance numbers，Dosage type with particles、Ointment and patch are the main。Indications are mainly respiratory diseases，For example, fever symptoms and bronchial asthma caused by acute upper respiratory tract infections (cold wind fever)，and gastrointestinal disease，If functional constipation accumulation、stake sports betting appPediatric wheel virus diarrhea, etc.。

 

 

  Compared with the launching pediatric chemicals that have been listed abroad，The development difficulty of traditional Chinese medicine children's science medicine is relatively large。Chinese medicine products can refer to foreign clinical trial data because there is no chemical medicine，often requires clinical research tests for children in China，The target patient of the Niuhuang children's retreat is 1 year old (minimum age) to 5 years old (maximum age)，The target patients of children's stool pellets are 0.5 years old (minimum age) to 14 years (maximum age)。