PC₂₀ versus PD₂₀: Why Change a Scientifically Well-Established and Clinically Relevant Test?

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...

Chemistry is an empirical science. Scientists often pose questions to understand the chemistry in everyday life and seek answers to these questions. To achieve this, scientists follow a definitive series of steps that together make up the Scientific Method. This approach involves making observations, asking questions, building a hypothesis, conducting experiments, analyzing results, and forming a conclusion. 

The scientific method is a detailed, empirical problem-solving process used by biologists and other scientists. This iterative approach involves formulating a question based on observation, developing a testable potential explanation for the observation (called a hypothesis), making and testing predictions based on the hypothesis, and using the findings to create new hypotheses and predictions.
Generally, predictions are tested using carefully-designed experiments. Based on the outcome of these...

Research is what makes the difference between facts and opinions. Facts are observable realities, and opinions are personal judgments, conclusions, or attitudes that may or may not be accurate. In the scientific community, facts can be established only using evidence collected through empirical research.

Scientific Laws

A system at equilibrium is in a state of dynamic balance, with forward and reverse reactions taking place at equal rates. If an equilibrium system is subjected to a change in conditions that affects these reaction rates differently (a stress), then the rates are no longer equal and the system is not at equilibrium. The system will subsequently experience a net reaction in the direction of a greater rate (a shift) that will re-establish the equilibrium. This phenomenon is summarized by Le...