26. September 2017
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.
09. March 2017
Introduction The purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European Union. It is intended to provide guidance for Applicants/MAHs, drug product, drug substance and excipient manufacturers, as well as regulators. In addition to new applications, it will also apply to variations to existing authorised medicinal products. Guideline
30. August 2016
Abstract Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis on the activities concerning non-biological complex drugs (NBCDs), the mechanisms by which new monographs are introduced into the European and the US pharmacopoeias are presented. Introduction Over the last decades we came to realize that high molecular weight drugs of biological origin,...
22. March 2016
An increasing elderly population is leading to a change in the global demographics. This presents a new challenge to society and the pharmaceutical industry. This demographic shift is providing an opportunity for the pharmaceutical industry to meet the specific needs of the changing patient population. One issue that has been identified is defining what is meant by “an older patient”, since this definition cannot be simply limited to chronological age. The fundamental purpose of the design...
10. March 2016
With the first deadline for the ICH Q3D guideline on elemental impurities just a few weeks away, pharma companies are still facing some uncertainty about how to comply with the requirements. After June of this year, any pharma company in ICH regions wishing to file a marketing application for a drug will have to comply with the guidance, while established products will have to be ICH Q3D-ready by December 2017. In essence, ICH Q3D introduces a risk-based approach to the control of elemental...