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Various guidelines harmonized in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (e.g., Good Manufacturing Practice guide for Active Pharmaceutical Ingredients) and originally prepared for new drug products, also play important roles in the production of high quality generic drug products.
Thus, agreements on harmonization of regulations and guidelines can be more complicated and difficult to achieve than may seem to be the case.
Therefore, this use case is focused on harmonization of geo data related to transport.
International Conference on Harmonization of technical requirements for pharmaceuticals for human use.
The study was performed in accordance with the current version of the Declaration of Helsinki and the International Conference on Harmonization of Good Clinical Practice Guidelines.
The International Council on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use [1994. Guidelines for industry: Dose-response information to support drug registration. ICH-E4.
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The proposed SIC method was validated under the optimized conditions according to the guidelines of the main regulatory agencies, namely International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use [25] and the International Union of Pure and Applied Chemistry IUPACC) [26].
The design, implementation, and reporting of the VISION study are strictly in compliance with the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (GCP), and the Helsinki Declaration of ethical principles [ 39, 40].
Indeed, the guidelines from the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use (EMEA 1998) explicitly state that such analyses should be used in an exploratory manner only and that conclusions as to the efficacy of a treatment should not be based on such analyses alone (Boonen et al 2005).
The study was conducted in accordance with the Declaration of Helsinki and with International Conference on Harmonization principles of good clinical practice.
Agreement on a protocol depends on ongoing harmonization of DTI analysis across ENIGMA sites, which is being finalized by the ENIGMA-DTI working group (Jahanshad et al. 2013a).
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