March 28, 2019
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.
Analytical Methods
October 2, 2019
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
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 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
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
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.
June 17, 2021
Colman Byrne, a senior analytical services expert at DSI, describes the molecule assessment process as detective work, in which physical chemists assess different pieces of information to solve a puzzle. Questions that must be answered in the process include: What is the product supposed to be and do?
August 26, 2023
In any pharmaceutical development program, there are risk-benefit analyses being done to assist with decision-making processes. Expedited development presents a different balance to a company’s risk-benefit in order to bring a particular molecule forward as quickly as possible because of the potential benefits.