Dietary Biotin Interference in Hybrid LBA-LC-MSMS Assays Characterization, Impact, and Recommendations
Safety Pharmacology Studies Review — A Review
Safety pharmacology studies are defined in the International Conference on Harmonization (ICH) S7A guidance as “those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above.”
In other words, they are a set of tests focused on potentially adverse effects of pharmaceutical or biological agents, differing from traditional toxicology studies as they are typically concentrated on a single organ or physiological system.
In Issue 13 of The Altascientist, we take a look at the requirements, best practices, and core and supplemental study considerations, including:
- Cardiovascular system
- Central nervous system
- Respiratory system
- Species selection
- Routes of administration
- Dose level selection and duration
- Supplemental (follow-up) studies
- Safety pharmacology endpoints on traditional toxicology studies
Selectivity, Selectivity, Selectivity - a New Dimension by Differential Mobility Spectrometry
Complimentary webinar to learn how Altasciences can tackle your most challenging bioanalytical assays by combining the high sensitivity of the SCIEX 6500+ TripleQuad with ion mobility technology to achieve next level detection limits with unprecedented selectivity.
Utilizing Nano Particulate Formulations in the Delivery of Poorly Soluble Drugs
Safety Tolerability and Pharmacokinetics of GIC-1001 Following Multiple Ascending Doses Administrations Through an Adaptive First-in-Human Study in Healthy Volunteers
Cognitive Performance and Psychedelic Effects Following Single and Multiple Ascending Doses of a New Cannabis Formulation
Determination of Pirfenidone and Metabolites in Rat Plasma by Coupling On-Line Fractionation with LC-MS-MS
Microsampling - Making a Difference in Drug Development
Microsampling volume
Blood microsampling is a less invasive and simplified alternative to traditional venipuncture, and provides significant ad
