E-Validation: A Method for Electronic Validation Protocol Generation, Approval, and Execution

The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Xiao-Yan Cai, PhD, shares insights into her leadership style, the importance of motivation in the workplace, and how she balances repetition with innovation, discussing how hobbies and resilience uniquely shape her professional approach, emphasizing the value of perseverance and preparation in both science and life.

Compliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.