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

UsernamePublicRestriction
UsernamePublicRestriction

Excipient Database Should Help Take Mystery Out Of ICH Q3D Risk Assessments

Executive Summary

The pharmaceutical industry is developing an excipient database to better enable industry to conduct risk assessments set out in the ICH Q3D guideline.

You may also be interested in...



Drug Makers Urged To Collect Own Excipient Metals Data To Comply With ICH Q3D

While leveraging published data may help pharmaceutical manufacturers understand the general risks of using excipients with known elemental impurities, it is less helpful in understanding specific risks.

ICH Q3D Metal Impurities Guidance Issued By FDA, EMA, Health Canada

Regulatory members of the International Council on Harmonization have issued Q3D guidance on metal impurities that, while harmonized, differs in emphasis.

FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications

More flexibility on residual solvents obtained from FDA's Office of Generic Drugs.

Topics

UsernamePublicRestriction

Register

SC081785

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel