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March 11, 2014
HHS plan makes progress in ensuring availability of safe vaccines.
March 06, 2014
Schott's 20-mL TopPac prefillable polymer syringe simplifies the infusion-therapy preparation process.
March 02, 2014
Despite the progress made in nanomedicine development, there are several issues that remain unresolved. Raj Bawa, PhD, provides insight.
Accelerated testing and production create challenges in documenting product quality.
Nanomedicines can offer promising benefits in the diagnosis and treatment of diseases but there are still concerns about the safety and quality of these therapeutics partly because of the lack of clear regulatory guidance. Scott McNeil, PhD, director of the Nanotechnology Characterization Laboratory (NCL), spoke with Pharmaceutical Technology about nanomedicine characterization.
Advances in nanomedicine have provided several potential candidates for safe and effective delivery of siRNA.
With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.
A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.
February 26, 2014
Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.
February 19, 2014
New methods of encapsulation and filtering address scale-up challenges.
