Analytics

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Ashvin Patel, PhD, is the director of Analytical Research & Business Development, Teledyne Hanson Research, New York, USA.

Articles

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence

Editor of Pharmaceutical Technology Europe

Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.

Ensuring Patient Safety Through Elemental Impurity Analysis

Grant Playter is the Assistant Editor for 

Dissolution testing has seen recent trends that have led to increased data integrity solutions as well as an increase in biorelevant testing techniques.

Dissolution Testing Sees Advances

Chris Spivey is the editorial director of 

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

Ensuring CGMP Standards for Data Integrity

Toby Blackburn is head of Business Development and Strategy at Emerald Cloud Lab.

The “cloud lab” is a virtual laboratory setting that can enable scientists to more quickly advance research.

Accelerating Scientific Research Using the Cloud

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

Assessing the Success of CRISPR Gene Therapies Using ddPCR

The challenges of conducting protein characterization can be overcome through the use of technologies that empower scientists in their analytical work. 

Protein Characterization Strengthened by Enabling Technologies

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.

Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2—Dissolution

Adam Lambert, PhD, is the VP, product and process development, for Pharmatech Associates, a USP company.

Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.

Common FDA 483 Observations for Combination Products

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications. 

Analytical Method Development