To describe the standardization process and reliability of anthropometric and bioelectrical impedance analysis (BIA) measurements. We examined both intra- and interobserver errors for skinfolds, ...

One reason given for proactive participation and earlier submission of a monograph was the possibility of prospective or informal harmonization across multiple pharmacopoeias. It is instructive to ...

In the context of international trade, the need to develop global quality standards for medicines is increasing. Susanne Keitel, PhDQuality standards are vital instruments in the context of marketing ...

Several industry groups and drugmakers have written to the US Food and Drug Administration (FDA) to ask the agency to harmonize its recent draft guidance on developing fermentation and semi-synthetic ...

The International Conference on Harmonisation's (ICH) plans to implement changes to minimize the role of industry in its harmonization efforts going forward, making it the second international ...

This session, describing harmonized regulations and standards-setting in other sectors, offered two in-depth reports. The first was a look at international harmonization efforts for a completely ...

Support the resolution of differences across countries in setting national and international nutrition standards; Promote consistency in public and clinical health objectives; Provide a mechanism for ...

In this interview, News-Med talks to Tammy Newbold about the Global Harmonization of Regulatory CMC within Veterinary Medicine. Can you explain what global harmonization of regulatory CMC entails and ...