FDA Commissioner Emphasizes the Importance of Modeling and Simulation to Increase Efficiency and Reduce Costs in Drug Development

Dr. Scott Gottlieb, FDA Commissioner, delivered a speech to the Regulatory Affairs Professional Society Conference on September 11, 2017 highlighting the importance of advanced statistical and computational methodologies in the drug development and review process. Among these methodol
Life in the fast lane

Life in the Fast Lane: FDA Programs to Expedite Product Development and Review

Medical product development can be both challenging and time-consuming and while FDA reviews are often more rapid than international peers, every day that your product is not on the market is a missed opportunity for revenue and for helping patients. Timing is especially critical for

Seven Pitfalls to Avoid in Your Next Phase 1 Study

Study design and subject safety are of the utmost importance in a Phase 1 study. It is also important to be wary of pitfalls as you plan your clinical trial. Based on our extensive experience in clinical pharmacology, some of the challenges that we have come across include: Selecting

Understanding Adaptive Design Clinical Trials

By: Rex L. Williams, Ph.D., Associate Director, Program Management & Manager, Clinical Pharmacology The FDA released its draft guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” in 2010 and in so doing provided a framework for designing more efficient and often

A Winning Combination: Efficient Drug Development for Combination Products

By: Brandon D. Burch, M.S., Ph.D. Senior Manager, Scientific Writing & Regulatory Affairs In a previous post, we discussed how combination products are defined in the Code of Federal Regulations, introduced FDA’s Office of Combination Products, and touched on a few unique aspects

So Happy Together: Combination Products and the FDA

By: Brandon D. Burch, M.S., Ph.D. Senior Manager, Scientific Writing & Regulatory Affairs Drug, biologic and device combinations have the potential to make treatments safer, more effective and/or more convenient for patients. But obtaining approval for a combination product involv

Three Steps to Gauge Biosimilarity

By: M. Alexander Shaw, Ph.D., Chief Operating Officer Biosimilarity refers to the relationship between a proposed protein therapeutic (biologic) product and an approved reference product. Biosimilarity is similar to bioequivalence in proposed generic drugs in the small molecule world.
Repeat Dose Image

Understanding the Pharmacokinetics of Repeated Doses

By: Mark Bush, Ph.D., Senior Consultant, Pharmacokinetics & Clinical Pharmacology Most prescription drugs are administered repeatedly for a limited duration (for acute illnesses) or for an extended period of time (for chronic conditions).  As such, it is important to understand th

Pharmacogenomics: What is it and how is it used?

By: Todd Shearer, Ph.D., Executive Director, Nonclinical & Clinical Pharmacology What is Pharmacogenomics? Pharmacogenomics (PGx) refers to the study of drug exposure and/or response as it relates to potential individual genetic variations. Genetic variation in drug metabolizers,

Considerations When Designing Studies for Elderly Populations

By: Mark Bush, Ph.D., Senior Consultant, Pharmacokinetics & Clinical Pharmacology The aging of the American population has resulted in an increased interest in developing drugs for elderly patients.  A key principle of drug development is that drugs should be evaluated in all age