Understand why the FDA's shift toward single pivotal Phase III trials requires establishing a drug's mechanistic hypothesis ...
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical ...
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into ...
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits ...
Effective regulatory responses are concise and evidence-based, explicitly connecting observations to root cause, corrective ...
FDA will review discrete IND modules during pre-IND rather than waiting for a full submission, with the goal of de-risking ...
Patrik Florencio | Authors | Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and expert industry news.
As cell and gene therapies move from bespoke academic protocols into commercial-scale manufacturing, the raw materials underpinning them are emerging as one of the most consequent ...
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains that developing a molecule requires a holistic view of its chemical, physical, and biological properties. As part ...
Risk management in medical devices carries 2 identities. ISO 14971 defines a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk, and monit ...
Timothy Bassler, SVP of Quality Operations at PCI Pharma Services, presented "Driving Quality Culture to Manage Risk," using a ...
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains that developing a molecule requires a holistic view of its chemical, physical, and biological properties.
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