Analytics

Articles

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

SÃ¡ndor KemÃ©ny* is an emeritus professor at Budapest University of Technology and Economics, Faculty of Chemical Technology and Biotechnology, Department of Chemical and Environmental Process Engineering.

MÃ¡tÃ© Mihalovits is a PhD student at Budapest University of Technology and Economics.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested. 

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

The CPhI Pharma Award for Excellence in Analysis, Testing, and Quality Control went to B&W Tek for its handheld laser induced breakdown spectroscopy (LIBS) analyzer, NanoLIBS, which has been developed for rapid identification of solid materials based on elemental analysis. The instrument features a raster scan using a high repetition rate class 3B laser allowing for detection of elements including C, Li, and Be.

B&W Tek Takes Analysis, Testing, and Quality Control Award at CPhI

Graham Cook is senior director process knowledge/quality by design at Pfizer.

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Katherine Ulman is a Global Regulatory Compliance Manager at Dow Corning.

Lance Smallshaw is worldwide analytical expert for biologics and strategies, corporate analytical sciences, UCB

Carlos W. Lee is an associate research fellow, analytical research and development, pharmatherapeutics pharmaceutical sciences, Pfizer, Inc.

Helmut Rockstroh is head, pharmacopoeial affairs office, F. Hoffmann-La Roche Ltd.

John Glennon is a stability laboratory team leader, GlaxoSmithKline

Samuel Powell is a scientist, analytical research and development, pharmatherapeutics pharmaceutical sciences, Pfizer, Inc.

Cyrille C. ChÃ©ry is a senior scientist, analytical sciences for biologicals, UCB Pharma SA

Laura Rutter is a SM manager, analytical services at GlaxoSmithKline

Laurence Harris is an associate research fellow, analytical research and development, pharmatherapeutics pharmaceutical sciences, Pfizer, Inc.

Vicki Woodward is a technical services manager at AstraZeneca

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Susanne Keitel, MD, is head of the European Directorate for the Quality of Medicines of the Council of Europe. EDQM is responsible for the European Pharmacopoeia.

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

Finished Product Monographs in the European Pharmacopoeia

New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation.

Combining Spectroscopy with Automated Imaging: A New Analytical Solution to Meet Regulatory Requirements for Inhaled Products

This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders.

Developing a Comprehensive Approach for Preventing Metal Contamination of Pharmaceutical Products

The authors evaluated the manufacturing data of 40-mg tablets of furosemide, a potent diuretic.

A Statistical Approach to Evaluating the Manufacture of Furosemide Tablets

Carina Rubingh is Biostatistician in the group of Analytical Information Sciences at the Department of Analytical Research, TNO Quality of Life (The Netherlands).

Kees van de Voort Maarschalk is Director Oral and Polymeric Product Development at Schering Plough (The Netherlands) and Professor Industrial Pharmacy at the University of Groningen (The Netherlands).

Uwe Thissen is Project Manager and Senior Scientist in the group of Analytical Information Sciences, Department of Analytical Research, TNO Quality of Life, Business Unit Quality and Safety, PO Box 360, NL-3700 AJ Zeist (The Netherlands). Tel. +31 30 694 4002 

Statistics are often viewed as confusing and complicated, but multivariate data analysis (MVA) methods can be used to amass knowledge simply.

Finished Product Analysis