The US Food and Drug Administration (FDA) issued new draft guidance in December 2016 indicating that generic manufacturers can demonstrate bioequivalence for a specific semi-solid dosage form using predictive in vitro testing as a surrogate for in vivo testing. In this paper, we explain how bioequivalence can be achieved for generics in semi-solid dosage forms, including the role of in vitro release testing (IVRT) and in vitro permeation testing (IVPT).
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The diagnosis and treatment of human diseases and the development of new drugs increasingly rely on our ability to determine patient genotypes using accurate and sensitive pharmacogenomic tests. Many PCR and next-generation sequencing (NGS) based assay platforms are currently available.
However, the type of DNA sequence variants, the number of targets, and the sensitivity requirements are highly diverse in different studies. Here Dr. Peter Zhang describes the design, performance, and regulatory considerations of several assay platforms that are accurate, high throughput, cost-effective and customizable. These platforms provide high-quality pharmacogenomic data ideally suited to meet the needs of individual studies.
With more monoclonal antibody (mAb) drug conjugates (ADC’s) under preclinical development and in clinical studies, comprehensive and reliable pharmacokinetic evaluation of ADC moieties is increasingly demanded. Liquid chromatography coupled to mass spectrometry (LC-MS) methods have served as sensitive, selective, and versatile tools for ADC PK profiling. In this poster, we present ADC LC-MS methodology approaches used at Frontage.