The European baseline series and recommended additions: 2023

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...

Profile leveling and cross-sections are surveying methods used to determine and document terrain elevations for infrastructure projects such as highways, railroads, canals, and pipelines. These methods provide data for earthwork planning and alignment of proposed routes.  Profile leveling involves measuring elevations along a fixed line to create a vertical terrain profile. A surveyor sets up a leveling instrument at the benchmark (BM) and records a backsight (BS) to determine the instrument's...