Bioanalysis
Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides
Current Strategies for Using Commercial LBA Kit in Regulated Bioanalysis
ISSUE NO. 33 — End-to-End CNS Drug Development Solutions
In Issue 33 of The Altascientist, we explore how a comprehensive, end-to-end integrated approach to drug development for central nervous system (CNS) therapeutics can take you seamlessly from lead candidate selection to market.
Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning.
With detailed case studies, study considerations, and more, this Issue covers:
- preclinical safety and toxicity testing,
- formulation and manufacturing,
- early-phase clinical trials, and
- bioanalysis.
Four Key Steps to Optimizing a Large Molecule Bioanalytical Program
Biologics are large, complex molecules that can undergo structural changes during the manufacturing process, storage, or administration to patients. This means bioanalysis of biologics is a critical aspect of the drug development process, and one that requires sensitivity, specificity, and selectivity.
Hybridization LC-MS/MS Workflow to Quantify an siRNA Drug Candidate in Plasma, CSF, and Tissues
Dr. Keyhani Reflects on International Day of Women and Girls in Science
Opinion | A Day to Celebrate, and a Call to Action
Dr.
ISSUE NO. 30 — The Evolution and Advancement of Liquid Chromatography-Mass Spectrometry in Drug Development
The drug development landscape is constantly evolving, with science and technology advancing hand-in-hand to improve the essential steps of determining drug concentration profiles and the characterization of drug transformation products. The ultimate goal is to better understand drug distribution, metabolism, and pharmacokinetic characteristics, and to present regulatory bodies with a complete and comprehensive submission package driven by current guidelines.
To this end, liquid chromatography (LC) coupled with mass spectrometry (MS) via an atmospheric pressure ionization (API) interface is a well-established analytical approach to support each phase of drug development, from early discovery through to clinical studies.
In Issue 30 of The Altascientist, we explore the numerous benefits of incorporating a stable isotope labelled internal standard for quantitative LC-MS, and detail recent advances in MS technology, including:
- stable isotope labelled internal standards (SLIS) for LC-MS quantitation
- dried blood microsampling
- anti-epileptic drug panel
- COVID-19 neutralizing monoclonal antibodies
- differential mobility spectrometry
- bioequivalence
- large molecule bioanalysis
- oligonucleotides
Also included are several case studies, which exemplify novel bioanalytical workflows that are required to meet the challenges faced in both nonclinical and clinical development, across a variety of drug classes.
Ophthalmic End-to-End Drug Development Solutions
Test Your Knowledge of PCR Applications
PCR testing continues to be in the spotlight as a reliable way of screening for COVID-19 and other viruses in patients. Its amplification process enables it to detect small portions of genetic material in these viruses. But PCR can be also used for a broad range of additional applications.
Immunogenicity Target Interference: A Novel Blocking Approach