Drug Development

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

Biosimilars Face Repercussions of Drug Pricing Debate

director of Scientific Writing and Regulatory Affairs at Sciformix Corporation

If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

FDA’s Proposed Generic-Drug Labeling Rule: Ensuring Efficiency and Compliance

Rong-Kun Chang, PhD, is associate director at Supernus Pharmaceuticals.

Susan Rosencrance, PhD is with the Center for Drug Evaluation and Research, FDA

Andre Raw, PhD is with the Center for Drug Evaluation and Research, FDA

Bing Cai, PhD, is acting director, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Pahala Simamora is acting branch chief, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

Common Deficiencies in ANDAs for Dermatologic Drug Products

Aikaterini Lalatsa, PhD, is a lecturer in pharmaceutics and drug delivery at the School of Pharmacy and Biomedical Sciences, University of Portsmouth, St Michael’s Building, White Swan Road, Portsmouth PO1 2DT, United Kingdom, email: katerina.lalatsa@port.ac.uk, tel.: +44 (0) 23 9284 3929,

Diana M. Leite is a PhD student at the School of Pharmacy and Biomedical Sciences, University of Portsmouth, St Michael’s Building, White Swan Road, Portsmouth PO1 2DT, United Kingdom.

Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.

De-activating the Ticking Bomb of Brain Diseases with Nanomedicines

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.

Aptar Pharma Forms Pact with BD to Develop Novel Autoinjector

Brian Carlin is global manager of pharmaceutical research and development at FMC-Biopolymer (Princeton, NJ).

One of the major challenges in working with excipients today is understanding, and adjusting to, complexity in materials and formulations.

Dealing With Complexity in Excipients and Formulations

David Smith is CMO manager at Glide Pharmaceutical Technologies Ltd.

Alex Lyness is an enterprise fellow at Loughborough University, Healthcare Engineering Group, Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering,Loughborough University, Leicestershire, UK.

David Grant is technical lead, new technologies, david.grant@glide-technologies.com.

Scott Constable is principal project co-ordinator, QuotientMetabolism at Quotient Bioresearch (Rushden) Ltd.,Northamptonshire, UK.

Johannah Sharman is regulatory affairs manager at KalvistaPharmaceuticals Ltd.

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 Novel Solid-Dose Injection

Agnes Shanley is senior editor of Pharmaceutical Technology.

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

Data Integrity Emerges as an Excipients Issue

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.

Topical Formulation: Moving From Art to Science

Robert Strub is director of business development at Gaylord Chemical Company LLC.

The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.

Formulation and Drug Delivery