Analytics

Articles

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

Validation of a Multiplex Bead-Based Assay

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Rapid Screening for Elemental Impurities using ICP-MS

Jeff Hofer is a principal research scientist at Eli Lilly and Company.

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

Yuan Huang is a senior scientist at Eisai.

Mark Argentine is a senior research advisor at Eli Lilly.

Qinggang Wang is a principal scientist at Bristol-Myers Squibb, qinggang.wang@bms.com.

Shreekant Karmarkar is a senior research scientist at Baxter.

Hafez Abdel-Kader is a director at Sanofi.

Lakshmy M. Nair is a senior research scientist at Baxter.

Andrea M. Pless is an associate director at Teva

Rick Burdick is a quality engineering director at Amgen.

Zeena Williams is a senior associate director at Boehringer Ingelheim

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

Using Quality by Design to Develop Robust Chromatographic Methods

For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.

Ensuring Sound Bioanalytical Methods Transfer

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial

Granulation Method and Process Monitoring Matter

FDA updates guidance to reflect advances in technology.

FDA Reissues Bioanalytical Method Validation Guidance

Michael Rooney, director, bioanalytical development at Jazz Pharmaceuticals, provides an overview of a life cycle strategy for analytical methods development, the need for standards and guidance documents, and therole Quality by Design can play in method development.

Analytical Method Development Life Cycle

Now at a practical size and price, terahertz spectroscopy is advancing as a nondestructive method of analysis for solid forms and tablet coatings.

Rising Interest in Terahertz Spectroscopy in Pharmaceutical Analysis

New capillary-based imaging techniques for protein charge variant analysis are reducing development and start-up times for protein-based therapeutics.