Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Industry Prepares For Emerging ICH Q14 Quality-By-Design Approach To Analytical Methods

Executive Summary

EU industry group advises drug makers on how to prepare for enhanced quality-by-design approaches to analytical methods that the International Conference on Harmonization plans to propose early next year. ICH recently shared its concept, which involves revising its Q2(R2) guideline and adding a Q14 guideline, and its business plan for establishing the guidance.

You may also be interested in...

The ICH Plans To Propose Q14 Guideline On Analytical Testing In January

The ICH is expected to release for public comment early next year its draft Q14 guideline establishing a lifecycle approach for analytical testing, as well as a Q2(R2) guideline to add some newer analytical methods.

FDA Officials Suggest Ways To Smooth Path For Breakthrough Drug Approvals

How FDA officials think sponsors should overcome shortfalls in analytics and CMC information that challenge expedited breakthrough therapy review. 

Pharmaceutical Industry Adopting QbD for Analytical Testing

Both the pharmaceutical industry and regulators are exploring new QbD approaches for analytical method development. FDA regulators have approved analytical QbD submissions and say that regulatory relief will be granted to those firms that use this approach, while the EU has been less accepting.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts