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Metabolic syndrome was defined using the harmonised guidelines [ 20].
Prevalence levels for observed metabolic risk were determined using the harmonised guidelines [ 20].
9. Develop an open access website for researchers to communicate, improve data-collection and share patient information on prevention and health promotion, expert opinions, publications and harmonised guidelines.
The key reasons for the failure were defined as a lack of prior preparation, the absence of well-defined and harmonised guidelines and implementation mechanisms, and inadequate systematic training of the managers at the local government level [ 14].
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The method was first validated in-house according to the IUPAC harmonised guideline for single-laboratory validation.
The fertility study design recommended in the ICH S5 R2) Harmonised Guideline for Detection of Toxicity to Reproduction for Medicinal Products emphasizes the importance of histopathological endpoints next to a pairing assessment in evaluating male fertility.
Both studies were performed in accordance with the Declaration of Helsinki, International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice and local regulations.
The trial was carried out in compliance with the Declaration of Helsinki (1964, as revised in 2008), in accordance with the International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice and local regulations.
The clinical trial protocol was approved by the Institutional Review Boards of the participating centers, and complied with the Declaration of Helsinki in accordance with the International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice.
The trial was conducted in compliance with the principles laid down in the Declaration of Helsinki, in accordance with the International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice (GCP), and in accordance with relevant Boehringer Ingelheim standard operating procedures and the Japanese GCP regulation.
The International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines: Good Clinical Practice document [ 8] uses the Helsinki language and defines 'legally acceptable representative' as 'an individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subjects' participation in the clinical trial'.
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