Topic

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Articles

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors. 

Total Analytical Error in Validation of Analytical Procedures of Pharmaceuticals

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.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms

 is clinical assistant professor, University of Illinois College of Pharmacy in Chicago, IL, USA.

 is clinical laboratory instructor, University of Illinois College of Pharmacy in Chicago, IL, USA.

A fluorescence test method was used to visually evaluate handwashing efficacy. Difficult-to-clean areas on skin such as skin folds and webbing between fingers were identified; specific washing techniques to address problem areas are proposed.

Supplementary Handwashing Techniques to Improve Hand Hygiene

Sam Turner is director of Technology and Development at Capcium.

Naresh Talwar, PhD, is director of Product Development at Capcium.

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Advancements in soft capsule technology can enable the development of soft capsule formulations, which are becoming the preferred method of oral administration.

Novel Formulations and Line Extensions with Soft Capsule Technology

Moritz Perscheid is a pharmaceutical chemist at LGC.

It is argued that orthogonal quantitative methods can be used to establish primary working standards. An example details how to calculate the expanded measurement uncertainty (U) for the certified assay value by considering two orthogonal assay methods.

The Value of Primary Working  Standards in Pharmaceutical Quality Control

Sergio A. Bernal-Chávez, PhD, is research associate at Laboratorio de Investigación y Posgrado en Tecnología Farmacéutica (L-322, Campo 1), Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México.

Sergio Alcalá-Alcalá, PhD, is principal scientist at Laboratorio de Tecnología Farmacéutica, Facultad de Farmacia, Universidad Autónoma del Estado de Morelos, Cuernavaca, Morelos, México.

Doris Cerecedo, PhD, is principal scientist at Laboratorio de Hematobiología, Escuela Nacional de Medicina y Homeopatía, Sección de Estudios de Posgrado, Instituto Politécnico Nacional, Ciudad de México.

, is principal scientist at Laboratorio de Investigación y Posgrado en Tecnología Farmacéutica (L-322, Campo 1), Facultad de Estudios Superiores Cuautitlán, Universidad Nacional Autónoma de México.

The purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.

Thermogelling Matrix-Containing Platelet Lysate-Loaded Elastic Liposomes as a Potential Treatment of Wounds

Courtney O’Dell is senior scientist at Biopharma Production, Avantor.

Michael Hill was formerly senior research scientist at Avantor.

Lori Fortin is senior research manager at Biopharma Production, Avantor.

Jonathan Fura is manager, research & development at Biopharma Production, Avantor.

William Connors is scientist, research-upstream processing at Biopharma Production, Avantor.

Nandkumar Deorkar is vice-president, research & development, at Biopharma Production, Avantor.

Researchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.

A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing Process

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

Ammar Khawam, PhD, is a senior managing scientist of product development at Parsolex.

Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.

Process Performance as a Means of Quality Management

Yeli Zhang is North America Technical Manager IFF Pharma Solutions, Wilmington, DE.

Elizabeth Tocce is associate application development engineer, Dupont.

Holly Bertrand is Research Investigator IFF Pharma Solutions, Wilmington, DE.

Kevin McIntyre is Laboratory Supervisor, IFF Pharma Solutions, Wilmington, DE.

Fernanda Onofre, Americas Regional Applications Leader, IFF Pharma Solutions, Wilmington, DE.

Amina Faham is Global Director of Applications Development & Innovation; IFF Pharma Solutions, Wilmington, DE.

In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.

Peer-Reviewed Research