Introduction and reflections on the non-clinical data exchange standard SEND

SEND stands for Standard for Exchange of Nonclinical Data, non-clinical data conversion standard. The US FDA released Providing Regulatory Submissions in Electronic Format — Standardized Study Data in December 2014. This document formally proposed the SEND standard for non-clinical data.

SEND is not an independent standard, it is part of eCTD. Therefore, SEND was born in the context of electronic drug registration and submission in today's world. ICH released CTD (Common Technical Document) general technical document guidelines in 2000. CTD is a unified format for drug registration data, including drug quality controllability, safety and effectiveness. The first version of the eCTD Guidelines was released in 2003. eCTD is the electronic form of CTD, which is more convenient, environmentally friendly and efficient. Since the US FDA adopted eCTD in 2008, more than 40 countries/regions including the European Union, Japan, Canada and Australia have also implemented it.

Although my country has not yet begun to implement eCTD, electronic drug submission has many significant advantages over traditional paper submission. It is the general trend of international drug review and the development direction of my country's drug review. Therefore, it is very necessary to keep an eye on and understand the latest standards of international electronic filing.

1.Implementation Timetable

The FDA officially issued the guideline on December 17, 2014. The guideline clearly stated that applications for NDA (New Drug Application), ANDA (Abbreviated New Drug Application) and some BLA (Biological License Application) were approved 24 months after the release of the guideline. Animal experiments started after December 17, 2016 must be submitted in the SEND format. For some IND (Investigational New Drug) applications, animal trials started 36 months after publication, that is, after December 17, 2017, must be submitted in the SEND format.

In August 2017, the FDA announced its acceptance of SENDIG v3.1 (Standard Guidance for Nonclinical Data Conversion Version 3.1). NDA, ANDA and partial BLA applications, and trials starting after March 2019 must be submitted in accordance with the requirements of SENDIG v3.1. For partial IND applications, trials starting after March 2020 must be submitted in accordance with SENDIG v3.1.

2. Policies and regulations

The amount of data in pharmaceutical research is very huge, and integrating such huge data is a very complex task in itself. As a result, there are dozens of regulations and guidelines on electronic submission and data conversion, totaling more than 1,500 pages. This article focuses on several important documents.

Providing Regulatory Submissions in Electronic Format-Standardized Study Data. FDA officially released the SEND standard from this document.

STUDY DATA TECHNICAL CONFORMANCE GUIDE. This document is also issued by the FDA. This guidance provides instructions, recommendations, and general considerations for how to submit standardized trial data using FDA-accepted data standards. As a supplement to the previous document, it provides technical advice to companies on how to submit human and animal test data and related information in a standard form when filing for IND, NDA, ANDA and BLA. The purpose is to enhance mutual communication between submitters and FDA review departments. It is a very valuable reference document for understanding SEND.

What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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