The manufacturing of compressed solids is a complex process, requiring several steps to render powders compressible, yet easily dispersed, and with the active ingredient dissolved when placed at the site of administration. As a result, the formulations that deliver the drugs to the site of action, ...

Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the ...

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, ...