Analytical Methods

March 28, 2019

Knock, Knock, Who’s There? Preparing for an FDA End of Phase II (EOP2) CMC Meeting

three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency.
October 2, 2019

Hey Google, tell me about the importance of living Development Reports

Ready to help, wherever you are! Google's version of Amazon's Alexa, Apple's Siri and Microsoft's Cortana is Google Assistant. It has made incredible progress since its 2016 launch and is probably the most advanced and dynamic of the assistants out there.
October 29, 2019

CMC and Regulatory Affairs – See the forest and the trees

Here’s the problem: drug development managers must translate guidance into clear program objectives, identifying the data and information that needs to be produced, and prioritize resources and expenditures.
July 2, 2020

The Odd Couple – Part 3: Authoring the Control of Excipients Modules

The acceptance criteria and tests conducted for the excipients should be reviewed relative to the preformulation experimental results. The acceptance criteria for the excipients should consider those qualities critical to the drug product performance and manufacturing operation as described earlier in formulation development.
July 14, 2020

The Odd Couple – Part 4: Authoring the Analytical Control and Analysis and Reference Standards Modules

Perhaps the most consequential specification input is analytical method capability. The attribute of interest must, after all, be assessable. Thus specifications depend on the method’s specificity, sensitivity, variability, and accuracy.
July 23, 2020

The Odd Couple – Part 5: Authoring the Container Closure Systems for Packaging of Drug Substance and Product Modules

Container closure systems refer to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. The packaging information in the chemistry, manufacturing, and controls section usually includes a description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance and drug product during their use.