Articles by Adeline Siew, PhD - Pharmaceutical Technology

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Articles by Adeline Siew, PhD

Tackling challenges in the development of fixed-dose combinations

Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.
Apr 2, 2014

Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.

Navigating the Regulatory Landscape of Combination Products

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDAs final rule on current GMP requirements for combination products.
Apr 2, 2014

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

Nanosimilars and follow-on nanomedicines

Stefan Muhlebach explains why non-biological complex drugs (NBCDs) cannot be assessed using the standard generic or biosimilar approaches.
Mar 2, 2014

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.

Characterization of nanomedicines

A Q&A with Scott McNeil, PhD, director of the Nanotechnology Characterization Laboratory (NCL), on nanomedicine characterization.
Mar 2, 2014

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.

Current issues with nanomedicines

Raj Bawa, PhD, shares insight on the unresolved issues in nanomedicine development.
Mar 2, 2014

Despite the progress made in nanomedicine development, there are several issues that remain unresolved. Raj Bawa, PhD, provides insight.

Pulmonary Drug Delivery—Particle Engineering for Inhaled Therapeutics

Industry experts discuss the various factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.
Feb 2, 2014

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

Can Pharma Defy Gravity at the Patent Cliff?

Formulation strategies for product lifecycle optimization.
Dec 11, 2013

Formulation strategies for product lifecycle optimization.

Science-Based Technical Report Being Developed to Ensure Effective Use of Blow-Fill-Seal Technology

The Parenteral Drug Association has established a task force to develop a peer- and regulatory agency-reviewed Technical Report that will serve as a science-based industry reference document.
Oct 23, 2013

The Parenteral Drug Association has established a task force to develop a peer- and regulatory agency-reviewed Technical Report that will serve as a science-based industry reference document.

New Single-Use Bioreactor Technology Emphasizes Ease-of-Use and Intelligent Process Control

An updated bioreactor based on rocking technology has more advanced controls but is easier for biopharmaceutical manufacturers to use.
Oct 23, 2013

An updated bioreactor based on rocking technology has more advanced controls but is easier for biopharmaceutical manufacturers to use.

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