Considerations for 505(b)(2) Applications

By Michael J. Lamson, Ph.D. 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 and generally must show comparable bioavailability, although not

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., Director of Quality Assurance The FDA Guidance, “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products” addresses pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG), as well as pediatric study desi

5 Key Testing Considerations for Abbreviated New Drug Applications

By Bill Wargin, Ph.D. 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 Product. This information is covered under Food

2016 Holiday Donation to the National Organization for Rare Disorders

2016 Holiday Donation to the National Organization for Rare Disorders The votes are in! Moving into 2017, we wanted to give back by donating to research. We are pleased to announce that nearly 1,000 people voted and our Holiday donation will be awarded to the National Organization for
Drug Drug Interaction

Drug Interaction Studies Part 3: How In Vivo Studies Help Inform Drug Interactions

Drug Interaction Studies Part 3: How In Vivo Studies Help Inform Drug Interactions By: Celeste R. MacElrevey, PhD Previous posts in this series gave an overview of drug interaction studies  [Drug Interaction Studies Part 1] and in vitro studies [Drug Interaction Studies Part 2], based
Drug-Drug-InteractionStudies

Drug Interaction Studies Part 2: How In Vitro Studies Help Inform Drug Interactions

Drug Interaction Studies Part 2: How In Vitro Studies Help Inform Drug Interactions By: Celeste R. MacElrevey, PhD The previous post, Drug Interaction Studies Part 1: In Vitro, In Vivo Studies for NDAs and BLAs, introduced the 2012 FDA guidance titled, “Drug Interaction Studies – Stud
Drug Drug Interaction

Drug Interaction Studies Part 1: In Vitro, In Vivo Studies for NDAs and BLAs

Drug Interaction Studies Part 1:  In Vitro, In Vivo Studies for NDAs and BLAs By: Celeste R. MacElrevey, PhD Released in 2012, the guidance, “Drug Interaction Studies – Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations,” provides recommendations regard

How Food Interacts with Drugs in BA and BE Studies

How Food Interacts with Drugs in BA and BE Studies Written by: Bill Wargin, Ph.D., Executive Vice President, Pharmacokinetics Overview Food effect bioavailability (BA) studies and fed bioequivalence (BE) studies are both used during the investigational phase of drug research. BA studi

What is IVIVC?

What is IVIVC? Written By: Jessie Zhou, Ph.D. – Senior Pharmacokineticist An in vivo/in vitro correlation (IVIVC) adds in vivo relevance to in vitro dissolution specifications.  With this correlation model, the in vitro dissolution test can be used to predict the in vivo perform