The Q&A document addresses confusion regarding interpretation of the Q7 guideline and aims to harmonize expectations during inspections of both small molecules and biotech APIs. / read more /
A Federal circuit appeals court ruled that a biosimilar manufacturer must wait six months after FDA approval to commercially launch its medication. / read more /
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The SafeBridge Potent Compound Safety Certification programme identifies contract manufacturing organizations qualified in the safe handling of potent APIs and drug products. / read more /
Investment at Capsugel’s Edinburgh, Scotland facility will expand the company’s liquid- and semi-solid-fill capsule manufacturing capacity. / read more /
Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial. / read more /
Research is under way to gauge the prevalence of substandard, adulterated, and counterfeit drugs around the world and to help strengthen enforcement efforts. / read more /
Prodrugs and drug-delivery systems controlled by time, pH, and osmosis, are being used to prevent drug degradation in the stomach and small intestine and ensure drug release in the colon. / read more /
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Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more. Sponsored by: Dow
This webinar, led by Milton Boyer, senior vice-president of drug product manufacturing at AMRI, will review and challenge the changing paradigms in the CMO/drug sponsor relationship. It is clear that both CMOs and drug sponsors are being held responsible for the actions of the other. Responsibilities once thought to be clearly defined are changing, with new guidance and expectations revealed in 483s and FDA warning letters. Sponsored by: AMRI
Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations. / Click here /
This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.
