Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Doctors and Scientists

Biopharmaceutics

Biopharmaceutics is essentially comparing the dissolution of a drug to its in-vivo performance and its effectiveness. The drug under evaluation is studied carefully to determine the interrelationship between the dissolution of the drug and the consequent accumulation of the drug in key sites in the body. Since the rate of absorption is initially controlled by the rate of dissolution, the resulting plasma profiles and the elimination are subsequently affected. A good foundation of biopharmaceutics information will allow the pharmaceutical scientist to predict the time required for a therapeutic concentration to be achieved and to calculate its plasma concentration profile.

We study the physical and chemical properties of drugs and predict the biopharmaceutical characteristics of the drug. We use the Biopharmaceutics Classification System is a guide for predicting the intestinal drug absorption and for designing dissolution tests that can be used for establishing bioequivalence of different formulations. We will use biopharmaceutics to predict potential formulation development issues or to prevent possible adverse events in humans. One or our unique uses is to provide new intellectual property or new barriers to competition for drugs that are already approved.

Whether you are developing new formulations or interpreting clinical results, PharmaDirections’ biopharmaceutical experts can help you design and implement studies for maximum impact as well as making the most of the data you have on hand.

We use industry standard tools, such as WinNonLin and GastroPlus to go a step further in providing a deep scientific insight into how PK parameters can be changed by the design of controlled dosage forms. Activities we support include:

  • Calculation of Bioavailability Parameters
  • Bioavailability Studies in animals
  • Physical-Chemical Factors Affecting Oral Absorption
  • Formulation effects on bioavailability
  • In-Vivo performance predictions
  • Dissolution study and test design
  • New IP and new barriers to competition