C3TI will promote CDER’s clinical trial innovation activities both internally and externally ..read more

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions ..read more

In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor, Pharmaceutical Technology Group, interviews Dr. Krizia M. Karry, Global Head of Technical Marketing for BASF Pharma Solutions, on the topic of hot melt extrusion ..read more

The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications ..read more

Catalent’s approach to containment mitigates cross-contamination risk and regulatory issues, ultimately safeguarding patients. Download this article written by Karolina Narczykiewicz, an EHS expert at Catalent Pharma ..read more

Webinar Date/Time: Fri, Apr 26, 2024 11:00 AM EDT ..read more

Developing and manufacturing complex novel oral solid dose products of highly potent compounds requires specialized expertise. The level of containment necessary for a potent drug product is not just limited to potent or non-potent classification. The degree of potency and specific risks will determine the level of containment needed to ensure operator safety and prevent cross contamination at the development and manufacturing facility. This article discusses how to effectively classify highly potent APIs (HPAPIs), and to help develop containment protocols and manufacturing processes that are ..read more

Oral drug products that contain highly potent active pharmaceutical ingredients (HPAPIs) continue to be a driving force in the global pharmaceutical market. In this Q&A article, industry experts discuss some of the challenges in HPAPI drug product manufacturing and the key issues sponsors should consider when partnering with a contract development and manufacturing organization (CDMO ..read more

..read more

Ensure the success of clinical biomanufacturing programs by focusing on key tech transfer practices from the sponsor, commercial, scientific, and program management stakeholders ..read more