Blog
So, You Want to Be A Pharmaceutical Consultant?
So, you decided you want to try being a consultant. You may be ‘retiring’ after a long, successful career in corporate life, and you feel that you still have something to offer. Or, your position has been eliminated as part of restructuring/downsizing activities, and...
Knowledge and Technical Transfer Basics
The Pharmaceutical Industry currently embraces advanced digital technologies and automation but is moving towards the combined strengths of human creativity and machine efficiency to continue to drive technological innovation while prioritizing individual patient...
Dealing with Impurities in the Drug Substance and/or Drug Product during Development
As part of the development of any new drug substance and its conversion into an elegant commercially viable dosage form, it is necessary to have some understanding of its safety profile prior to it being administered in clinical studies to patients in therapeutic...
Formulation Development for Toxicology versus Clinical Studies
Formulation development of novel drug entities may be considered a combination of science and ‘art’. The ‘art’ part being based on the formulator’s ability to apply prior knowledge and experiences from other drug entities with non-similar and similar physicochemical...
Water Quality for Pharmaceutical Applications – Does It Matter?
Water is composed of two atoms of hydrogen and one atom of oxygen. Water comprises about 50-70% of the human body. It is essential for life. From a pharmaceutical perspective, it is a key component in the development, manufacture and stability of a variety of dosage...
Drug Product Quality
Introduction Drug Product Quality is a term one should be familiar with as part of routine drug development and manufacture. Recently while working with a small pharmaceutical company and their contracted development organization, an Incident Report documented the...
Drug Development Lessons Learned
The discovery, development and commercialization of a novel drug entity is not a quick or easy endeavor. Many compounds fail during safety and/or clinical testing for a variety of reasons. In addition, the compound may demonstrate chemical or physical characteristics...
Document Retention
Keeping track of data, development reports and other important documents for a given project for potential future need is always a concern for companies. Individuals working on a project may change; some will leave for other opportunities, and individual’s memories...
Manufacture, Retest and Expiry Date Revisited
Several years ago, I wrote about the relationships among date of manufacture, in-process hold times and drug product expiration date. Since then, there have been some developments that are worth revisiting. The corresponding guidelines of EMA (The European Medicines...
Botanical Drug Development
Introduction The use of plants as to treat various human maladies has been known since ancient times. Many of today’s drug products contain plant-derived ingredients. Botanical products may be classified as foods, dietary supplements, drugs, medical devices,...