One of the most critical factors to understand during drug development is bioavailability, which refers to the rate at which the drug product becomes available for bodily absorption. Dissolution testing can measure bioavailability by using a tablet dissolution apparatus, and we perform this practically every day. This instrument simulates the environment of the human gastrointestinal tract. Samples are taken throughout the study and assayed by HPLC to measure drug product concentration. A plot of the measured samples is created that show the concentration over time of the study to showing the rate of drug release from the dosage form.
VxP Pharma has the analytical scientists and laboratories to provide tablet dissolution testing services for all types of release profiles and drug product dosage forms.
GLP and cGMP Analytical Chemistry Services
Employing state-of-the-art instrumentation in HPLC and Dissolution testing, VxP Pharma develops analytical chemistry methods from initial concept to validation and can verify or improve existing methods for the analysis with a wide range of active compounds. All analytical services can be provided to meet GLP/GMP guidelines (or non-GLP as requested) for both small molecule synthetic drugs and large molecule biologics.
We follow all QA verified standard operating procedures in accordance with strict FDA guidelines. All testing is performed by experienced analytical chemists with documented training on cGMP and GLP guidelines. We offer a complete range of analytical testing services including method transfer, dissolution, assay and related compounds, and forced degradation and other stability testing.
The state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.