This is a summary report of the conference on “Analytical Methods Validation: Bioavailability,
Bioequivalence and Pharmacokinetic Studies.” The conference was held from December 3 …

Abstract The Third AAPS/FDA Bioanalytical Workshop, entitled “Quantitative Bioanalytical
Methods Validation and Implementation: Best Practices for Chromatographic and Ligand …

Conclusion For quantitative bioanalytical method validation procedure and requirements,
there was a relatively good agreement between chromatographic assays and ligand-binding …

The determination of the in vitro release profile of water-insoluble drug products requires
dissolution media different from those used for water-soluble drug products. Since the …

A method for the determination of in vitro release of hydrocortisone from creams using Franz
diffusion cell system and synthetic membranes has been developed. The use of synthetic …

The purpose of this study was to further establish the efficacy of pedicle screw stimulation as
a monitoring technique to avoid nerve root injury during screw placement. The study …

Objectives: Spinally elicited peripheral nerve responses, commonly called neurogenic motor
evoked potentials (NMEPs), are widely used to monitor spinal cord motor function during …

An in vitro procedure for the evaluation of sparingly water-soluble drug products has been
developed and tested. The data on several sparingly water-soluble drug products, such as …

The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of
Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of …

The in vitro drug release profile of hydrocortisone (HC) from creams, ointments, and lotions
has been determined using an automated procedure. A diffusion cell system and …