Introduction The intent of this article is to provide practical advice based upon gaps that the author has observed...
Archive for category: Analytical Discussion
Evaluation of an Automated Solid-Phase Extraction Method Using Positive Pressure
Pharma Live, , Analytical Discussion, 0Introduction Each year, 1.7 million people in the US are diagnosed with cancer; of these, approximately 580,000 will die...
Applying Quality by Design Principles to Analytical Methods to Gain Enhanced Method Understanding
Pharma Live, , Analytical Discussion, 0Introduction Quality by Design (QbD) concepts described in ICH Q8-101-3 can be applied to understand, reduce, and control sources of...
A Generic UHPLC-UV-MS Method for Cleaning Verification of Highly Potent Drugs
Pharma Live, , Analytical Discussion, 0Abstract Cleaning validation (CV) is a Good Manufacturing Practices (GMP) requirement in the manufacturing of drug substances and drug...
Analytical Method Development in the Quality by Design Framework
Pharma Live, , Analytical Discussion, 0The development of analytical methods in the Quality by Design (QbD) framework is currently gaining great momentum in the...
Investigation of Excipient Compatibility and Associated Degradations for the Formulation Development of a Small Molecule Pharmaceutical Compound
Pharma Live, , Analytical Discussion, 0Introduction Drug formulation starts with the selection of various suitable excipients for the desired or required dosage forms. Drug-excipient interactions can...
Automated Microbial Identification: A Comparison of USP and EP Approaches
Pharma Live, , Analytical Discussion, 0Introduction Microbial identification places an important role in pharmaceutical processing. Microbial identification can be defined as “microbial characterization by a...
Limulus Amoebocyte Lysate (LAL) users are exploring regimens to study the effects of adding endotoxin to undiluted biologics in reaction to Chen’s...
Introduction The Limulus amebocyte lysate (LAL) assay is the compendial test for the examination of bacterial endotoxin in pharmaceutical products (as described in...
The blood brain barrier and drug delivery to cns
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