Michael E. Swartz

The authors outline the ways in which forced degradation is used to develop a stability-indicating method and examine some of the method development and validation parameters critical to its success.

Second column in a series that reviews impurity method validation guidelines.

This column is the first installment in a two-part series reviewing ICH and FDA impurity method validation guidelines.

This column explores and highlights recently published guidelines for bioanalytical method validation.

Krull and Swartz describe how chromatographers can determine peak purity and identity using new software programs.

This month's "Validation Viewpoint" column examines the reasons behind problems with new drug applications submitted to the U.S. Food and Drug Administration (FDA). Ira Krull and Michael Swartz look at specific problems within analytical methods that raise red flags at the FDA.

Krull and Swartz examine validating cleaning methods for pharmaceutical manufacturing equipment and look at general requirements and specific cleaning procedures, sampling types, and analytical methods.

This month's column describes the ICH, its structure, member bodies, and operating procedures. Editors Krull and Swartz also give readers an update on ICH projects and guidelines.