Advanced analytics and modeling can be used to predict downstream failures, allowing for corrective action before batches are lost.
This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.
This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.
This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.
This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.
A quick look at the history of OTC dosage form development shows the importance of patient-centered innovation.
Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.
Extractables and leachables (E&L) testing for packaging-related impurities is essential to ensure cGMP compliance and, most importantly, patient safety.