Guidance for industry, investigators and reviewers: Exploratory IND studies
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Alternative approaches can be used if the approach satisfies the requirements of the applicable statutes and regulations. Discussions of an alternative approaches can be scheduled by contacting the FDA staff responsible for implementing this guidance. If the appropriate FDA staff cannot be located, contact can be made using the telephone number listed on the title page of this guidance.
OECD Principles of Good Laboratory Practice
NATA is pleased to advise that the OECD Position Paper Regarding the Relationship between the OECD Principles of GLP and ISO/IEC 17025 has been declassified by the OECD’s Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology. This document is now available on the OECD GLP public site.
It is hoped this paper will assist all stakeholders, including facilities, regulators and sponsors to understand the roles that each of these fundamental standards for good laboratory practice play in the production of quality data.
The paper was drafted by members of the OECD Working Group on GLP with significant input from ILAC which was pivotal to the final document.
Code of Federal Regulation (CFR) Title 21 Food and Drugs. Part 58 Good Laboratory Practice for Non-Clinical Laboratory Studies
This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.
World Health Organisation (WHO) Special Programme for Research and Training in Tropical Diseases (TDR). Handbook Good Laboratory Practice
The pertinent regulations in the preclinical scenario are the Good Laboratory Practice (GLP) regulations. These regulations are the subject of this handbook, which is a reference and support document, to help in the implementation of GLP. The Principles of Good Laboratory Practice of the Organisation for Economic Cooperation and Development (OECD) form the basis of this series of guidance documents
World Health Organisation (WHO) Special Programme for Research and Training in Tropical Diseases (TDR). Good Laboratory Practice Training Manual - For the Trainee
A tool for training and promoting good laboratory practice (GLP) concepts in disease endemic countries
(OECD): Good Laboratory Practice (GLP)
The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data (MAD).
European Commission. Chemicals - Good Laboratory Practice - Guidance Document for GLP inspectors and GLP test facilities - Cross-contamination of control samples with test item in animal studies
This document by the European Commission is a good resource for GLP inspectors and GLP test facilities.
Global Alliance for Genomics and Health: How we work
GA4GH Work Streams develop standards and tools that are founded on the Framework for Responsible Sharing of Genomic and Health-Related Data. Their work is designed to enable international genomic data sharing based on the specific needs of clinical and research Driver Projects - real-world genomic data initiatives sourced from around the globe.
The main sources of TheFreeDictionary's Medical dictionary are The American Heritage® Stedman's Medical Dictionary, Second Edition and Dorland's Medical Dictionary for Health Care Consumers, which provide authoritative descriptions of medical conditions, medications, anatomical terms, noted medical personalities and much more.
Merck Manuals: Overview of Genetics
Merck Manuals (within the United States and Canada) and MSD Manuals (outside the United States and Canada), are one of the world’s most widely used medical information resources.