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The methods of technology appraisal are described in the "Guidance for Manufacturers and Sponsors.
The same principles described in the guidance may be applied to pre- and post-approval changes.
The amount of information available on each event was limited, and the WHO Annex 2 decision instrument criteria described in the guidance were rigidly applied.
The methods used to estimate exposures to polyols are intended to be consistent with the EFSA approach for food additives described in the Guidance for Submission for Food Additive Evaluations of the European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources Added to Food (ANS) (EFSA 2012a).
All test substances were characterized in detail in accordance with the physico-chemical endpoints described in the guidance on information requirements for nanomaterials (ECHA 2012) to EU regulation No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH; Anon 2006).
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LoC refers to the general term as described in the ERA guidance documents [3, 7].
The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11).
The principles of pharmaceutical development relevant to QbD are described in the ICH guidance documents (ICHQ8-11) [1 3].
The methodology to fulfil this requirement is described in the transitional guidance document on mixture toxicity assessment for biocidal products for the environment [13], which is currently available from the ECHA website.
Our research group sought to further the science by conducting an empirical assessment of the relative benefits and limitations of two emerging methods for eliciting and collecting the patient perspective relative to traditional approaches described in the PRO guidance.
The general principles for the risk assessment of GM plants and derived food and feed are followed, as described in the EFSA guidance document of the EFSA Scientific Panel on Genetically Modified Organisms.
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