Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
Barcelona is set to host two well-known pharmaceutical events in the upcoming calendar year: CPhI (October 4–6, 2016) and BIO Europe Spring (March 20–22, 2017). The city is the heart of the BioRegion of Catalonia, believed to be the most dynamic bioregion in Spain and one of the most active in Europe.
A process-specific preventative maintenance program improves productivity and reliability.
Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
Multiple inspection techniques facilitate the identification of particulate matter in vials as part of root-cause investigations and safety evaluations.
Analytical methods need a boost to ensure quality control for cell and gene therapies.
A study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
A study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
A study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
A study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.
The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.
Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options.
Real-time, continuous optimization of holistic systems improves energy efficiency and performance at manufacturing plants and laboratories.
Following the United Kingdom’s decision to leave the European Union, there are two areas that demand attention-clinical trials and marketing authorization