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.
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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

Considerations for 505(b)(2) Applications

By: Michael J. Lamson, Ph.D., Vice President, Pharmacokinetics & Clinical Pharmacology Overview Section 505(b)(2) is a new drug application (NDA) that represents a hybrid of 505(b)(1) and 505(j) applications. It is used for approved drugs for which an “improvement” has been made a

When Should You Hire a Clinical Pharmacologist?

To outsource or to insource? The decision whether to hire a Pharmacokineticist or outsource clinical pharmacology work to a consultant is difficult.  When do pharmaceutical companies have enough work to support an in-house, full-time Pharmacokineticist?  Where is the inflection point

PK Considerations for Designing Pediatric Studies

By: Mary Roach, M.S., Senior Director, Quality Assurance; Senior Pharmacokineticist The FDA Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products” addresses pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG)

5 Key Testing Considerations for Abbreviated New Drug Applications

By: Bill Wargin, Ph.D., Executive Vice President, Pharmacokinetics To receive approval for an Abbreviated New Drug Application (ANDA), an applicant must demonstrate, among other things, that the proposed drug product is bioequivalent to the Reference Listed Drug (RLD) or Reference Pro