Traduction de «ligne directrice d essais » (Français → Anglais) :

Y2000 Personal Computer Testing Guidelines [ Y2000 PC Testing Guidelines ]

testing guideline

Barrier-free Design Standard Application Guidelines

Architecture and Urban Design Guidelines for the Federal Court

employment guidelines | guidelines for employment policy | guidelines for the employment policies of the Member States | EGs [Abbr.]

create a brand guideline | creating a brand guidelines | create brand guidelines | produce brand guidelines

provide guidelines and standards for content development | provide guidelines for content development

However, in order to avoid animal testing and the repetition of already performed tests, existing in vivo skin sensitisation studies performed according to valid OECD test guidelines or EU test methods and in compliance to good laboratory practice should be considered valid to fulfil the standard information requirement for skin sensitisation, even if the information derived from them is not sufficient for a conclusion whether a substance can be presumed to be a strong sensitiser.

In order to supplement or amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of: the amendment of Annexes I, II, IV and V to this Regulation in order to adapt them to technical progress or to take account of international regulatory developments in which the Union or the Member States are involved, in the field of clinical trials; the amendment of Annex III in order to improve the information on the safety of medicinal products, to adapt technical requirements to technical progress or to take account of international regulatory developments in the field of safety require ...[+++]ments in clinical trials endorsed by bodies in which the Union or the Member States participate; the specification of the principles and guidelines of good manufacturing practice and the detailed arrangements for inspection for ensuring the quality of investigational medicinal products; the amendment of Annex VI in order to ensure subject safety and the reliability and robustness of data generated in a clinical trial or to take account of technical progress.

Test methods for skin sensitisation are described in the OECD Guideline 406 (the Guinea Pig Maximisation test and the Buehler guinea pig test) and Guideline 429 (Local Lymph Node Assay).

Protocols should be in line with OECD Guideline 471 (Salmonella typhimurium Reverse Mutation Test), 472 (Escherichia coli Reverse Mutation Test), 473 (in vitro Mammalian Chromosomal Aberration Test), 474 (Mammalian Erythrocyte Micronucleus Test), 475 (Mammalian Bone Marrow Chromosomal Aberration Test), 476 (in vitro Mammalian Cell Gene Mutation Test) or 482 (Unscheduled DNA Synthesis in Mammalian Cells in vitro), as well as other relevant OECD Guidelines for in vitro and in vivo assays.