跳至主要内容

The meaning of SEND and its importance

 


SEND (Standard for Exchange of Nonclinical Data, non-clinical data exchange standard) is defined and maintained by the SEND team of the Clinical Data Inter-change Standards Consortium (CDISC). SEND is a method for collecting and presenting nonclinical data and is one of the required standards for submitting data to the FDA.

SEND Importance

According to the requirements of the US FDA, after December 17, 2016, applications for general toxicity tests (including single and multiple dose general toxicity tests) and carcinogenicity tests for NDA, ANDA, and BLA must be submitted in accordance with the SEND format standard; 2017 After December 17, 2019, general toxicity tests (including single and multiple dose general toxicity tests) for IND applications must also use the SEND format.

Safety pharmacology trials for NDA and BLA applications conducted after March 15, 2019, and safety pharmacology trials for IND applications conducted after March 15, 2020, are also required to be submitted to the FDA in SEND format. SENDIG 3.1 contains a subset of safety pharmacology, including respiratory and cardiovascular studies.

CDISC released the SEND standard SENDIG-AR for animal regulatory studies on September 17, 2019. FDA began to support this standard after March 15, 2020. For studies initiated after March 15, 2022, animal regulatory research The SEND dataset is required when submitting to the Center for Drug Evaluation and Research (CDER), depending on the type of regulatory submission.

On March 15, 2021, SENDIG-DART v1.1 was included in the FDA catalog and is based on SEND v 3.1 for the assessment of reproductive toxicity of antineoplastic drugs (primarily embryonic development (EFD)). Antineoplastic drug reproductive toxicity studies are required to use the SEND dataset for studies expected to initiate after March 15, 2023.

[1].SEND | CDISC https://www.cdisc.org/standards/foundational/send

[2].https://www.fda.gov/drugs/news-events-human-drugs/send-cber-what-you-need-know-12042020

标签：

评论

发表评论

此博客中的热门博文

The Launch Meeting was Held by Medicilon and DAC Biotech of the Contract Research on ADC Preclinical Study

  Chuansha, Shanghai, Nov. 8th, 2019 — Medicilon held the launch meeting with Hangzhou DAC Biotech Co., Ltd to initiate the   preclinical study   of the antibody-drug-conjugate (ADC)  DXC005, including the   pharmacology study ,   DMPK study   and the   safety evaluation . Medicilon has previously completed integrated  preclinical research  on ADC drugs cooperating with DAC Biotech and other companies. Two of them has been approved by NMPA and entered Phase I clinical trials. About Hangzhou DAC Biotech Co., Ltd Hangzhou DAC Biotech, Co., Ltd was officially registered in HEDA Area, Hangzhou City, Zhejiang Province, China around the end of Year 2012, and is located nearby the bank of beautiful Qiantang River. The company focuses on developing conjugate of monoclonal antibody and small molecular cytotoxic drug, both of which are banded together with smart linkers. About Antibody-Drug-Conjugate (ADC) ADCs ...
发表评论
阅读全文

Medicilon assisted Hangzhou DAC Biotech in approval of clinical study of ADC drug DAC-002

  On July 20, 2020, DAC Biotech’s new   ADC drug development , TROP2-ADC—DAC-002 was approved of clinical study by NMPA. for the indication of solid malignant tumor. Medicilon completed   preclinical pharmacokinetic  and toxicological studies in this project, accelerating the development process. DAC-002 is an ADC anti-Trop2 monoclonal antibody conjugated by an intelligent ligand against Tubulysin B analogue. It is used to treat Trop2 triple negative breast cancer, small cell lung cancer, non-small cell lung cancer and pancreatic cancer.Trop2 can promote the proliferation, invasion, metastasis and diffusion of tumor cells, and its high expression is closely related to the shortening of survival time and poor prognosis of tumor patients. Therefore, it is of great significance to study anti-tumor drugs targeted by Trop2. Reference: Medicilon Assists - The first China-made targeting folic acid receptor FRα ADC injection BAT8006 was approved for clinical use Medicilon As...
发表评论
阅读全文

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

  On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration.  The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages      Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies,  ADCs ,  mRNA vaccines ,  small nucleic acid drugs ,  PROTAC , and  CGT technical service platform  that have helped 421 INDs obtain clinical approval.  It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...
发表评论
阅读全文