Human medicinal center data extrapolation power children medicine research and development are put forward

On November 7, 2016

China pharmaceutical net

At present, China pharmaceutical industry dynamic 】 【 children medicine is faced with "no medical pediatrics", "adult medicine break half" awkward situation. Now, drug firms likely to use the data extrapolation to perfect and enrich pediatric population information.

Released on November 3, the adult dosage data extrapolation in the pediatric population of drug clinical trials and the relevant information of the technical guidelines "(draft), the human medicinal drug safety administration center (CDE) is put forward," as far as possible, reduce the pediatric population the number of subjects in drug clinical trials, through data extrapolation to improve drug pediatric population and rich information, to guide the clinical medication, become the important and necessary way of ensure the safety of children with drug use."

CDE also said that guidelines with emphasis on the concept and framework of the data extrapolation, pediatric population drug clinical trial data extrapolating the basic principles and requirements, provide the reference for the research and development enterprise.

"Considering the target group, the differences between the treatment and drug properties, data extrapolation method is its diversity and flexibility, this guiding principle only data extrapolation general considerations are put forward."

"Encourage the applicant in the pediatric population in the early stages of drug development and regulatory data extrapolation to communicate."

Research and development institutions should also reference drugs quality control standard for clinical trials (GCP), people with drug registration specification international coordination meeting (ICH) and other relevant guidelines require both at home and abroad, the CDE said.

This guideline is only on behalf of the drug regulatory agency of the current views and understanding, with the progress of the scientific research related content in this guideline will constantly improve, human medicinal center added.

Solicit opinions from the date of release as of two months. Can be in CDE fill send directly on site. (source: the healthy idea ihealth)