Articles in this Issue
Kimber Barnett, Ph.D, Kevin Doyle, Ke Wang, PhD, James Morgado, Jeffrey Harwood
Quality by Design (QbD) concepts described
in ICH Q8-10 can be applied to understand,
reduce, and control sources of variability in
pharmaceutical manufacturing processes.
As explored in a recent USP stimuli article,bthese same concepts can be applied to an analytical method if the method is considered to be a process with the output being a reportable result.
Carolin Gallert, Ellen Vorberg, Thomas Roddelkopf, Steffen Junginger, Heidi Fleischer, Kerstin Thurow
Each year, 1.7 million people in the US are diagnosed with cancer; of these, approximately 580,000 will die from the disease. Demand
for pharmacological investigations, specifically the determination of drugs in real samples, has become increasingly important to optimize cancer treatment.
Molly Jenkins, PhD
The rates of malignant melanoma are on the rise and, in some populations, lifetime incidence is as high as 1 in 50 individuals. These frequencies are especially concerning given that the current 5-year
survival rate of patients with late-stage melanoma is only 15%.
Scott M. Krull, Meng Li, Ecevit Bilgili, PhD, Rajesh N. Davé, PhD
Polymer films have emerged as a promising platform for delivery of pharmaceutical products in recent years. These films, generally used for oral delivery, are roughly the size of a postage stamp and can
be placed on the tongue for immediate release as well as under the tongue (sublingual) or on the inside of the cheek (buccal) for sustained release.
Ken Seufert
A story about a woman named Lauren Singer made its way through social media recently. The 23-year-old recent graduate lives in New York City and has kept 2 years’ worth of trash in her apartment.
Guy Tiene, MA
Pharmaceutical excipients, a broad array of substances blended with active ingredients into desired finished dosage forms, have, in recent years, made significant gains in quantities used and revenue
captured. The pharmaceutical industry has gradually recognized excipients are able to aid active pharmaceutical ingredients achieve better functionality and competitive advantage.
Marla Stevens-Riley, PhD
For the purposes of this paper, parametric release is discussed specifically for drug products terminally sterilized by moist heat. Parametric release can be defined as a sterility assurance release program where demonstrated control of the sterilization process enables a firm to use defined critical process controls, in lieu of the sterility test, to fulfill the intent of 21 Code of Federal Regulations (CFR)
211.165(a) and 211.167(a) and then release a product for commercial sale (Guidance for Industry: Submission of Documentation of Applications
for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes, 2010).
Adam Lanzarotta, Nicola Ranieri, Douglas C. Albright, Mark R. Witkowski, JaCinta S. Batson, Moseley Fulcher
The United States Food and Drug Administration’s (FDA) Forensic Chemistry Center (FCC) has been involved in the analysis of counterfeit products since the early 1990s. The first counterfeit examinations
conducted by the FCC focused on active pharmaceutical ingredients (APIs) and have since expanded to include finished product packaging materials (cartons, bottles, etc), finished dosage forms (tablets, capsules, solutions for injection, etc) and other products regulated by FDA such those listed in Table I .
Khanh Ha, Peter Tattersall, John A. Castoro, PhD,
Development and subsequent application of robust analytical methods are critical in the generation of accurate and precise analytical data to ensure the quality and safety of pharmaceutical solid
dosage form products. Sample preparation is a critical component within the analytical method to generate quality data to support: QbD principle formulation design, real time analytics, stability, and
release testing.