Authors
WuXi STA, a WuXi AppTec company
Latest:
Integrated Preformulation Studies for Fast Advancement of Drug Candidates to Human Clinical StudiesScreening for developability and solubility issues Assessing pH and food effect when evaluating bioavailability Addressing solubility challenges
Joseph H. Reibenspies, PhD
Latest:
Selecting a Specimen Holder for X-ray Powder DiffractionSpecimen mounting in x-ray powder diffraction affects peak positions and intensities.
Francesca McBride
Latest:
Overcoming Operational and Regulatory Challenges in Autologous Cell-Therapy FacilitiesManufacturers must address scale-out challenges of autologous cell therapy for commercial manufacturing.
Kevin O’Donnell
Latest:
Quality Quartets in Risk-Based Qualification: ICH Q9(R1) ConsiderationsQuality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
James P Stumpff
Latest:
Remote Inspections - Lessons LearnedThis article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.
