It’s only fair to share… Biocon Launches KRABEVA® in India, A Biosimilar Bevacizumab for Treating Several Types of Cancer On November 23, 2017, Biocon India’s premier Biopharmaceuticals Company announced that it has launched KRABEVA®, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, …
Category «Regulatory»
Normal Operating Range (NOR) and Proven Acceptable Range (PAR)
It’s only fair to share… In June of this year, the EMA issued a revision of their earlier Q&A document focused on NORs, PARs, and DSp.(2) First issued in draft form in 2015, this has been revised based on feedback and consultation with industry. The document focuses on five questions, which are summarized below along with …
ICH Q11 Q and A Document
It’s only fair to share… ICH Q11 Q and A Document The topic of starting materials has been a vexed topic for some period. Indeed concerns relating to lack of clarity and issues pertaining to practical implementation led the EMA in Sept 2014 to publish a reflection paper—Reflection on the requirements for selection and …
QbD Presentations
It’s only fair to share… Qbd by Anthony Melvin Crasto for API from Anthony Melvin Crasto Ph.D Organizational Initiatives Towards Developing Greener Processes for Generic Active Pharmaceutical Ingredients – Dr. Vilas H. Dahanukar, Chief Scientist-Process R&D, Integerated Product Development Organization, Dr. Reddy’s Laboratories Ltd., India presented at 4th Industrial Green Chemistry World Convention & …