Articles by Adeline Siew, PhD - Pharmaceutical Technology

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Articles by Adeline Siew, PhD

Tracking the Pulse of the Pharmaceutical Industry

Aug 1, 2014

Pharmaceutical Technology Europe marks its 25th anniversary.

Advances in Controlled-Release Drug Delivery

Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.
Jun 2, 2014

Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.

Freeze Drying Protein Formulations

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.
May 2, 2014

Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.

Extractables and Leachables Testing

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.
May 2, 2014

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.

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.

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.

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.

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.

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.

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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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