

Regulatory Guidance
Drug-Drug Interaction (DDI) Prediction Models Following In Vitro Studies in Preclinical Development
- Drug Drug Interactions (DDI)
- August 12, 2020
- Madison Knapp, Dr. Pallavi Limaye, Andrea Wolff, Dr. Maciej Czerwinski
In preclinical development, a drug will be evaluated for potential to cause a drug-drug interaction (DDI) using in vitro experiments and then calculations that...
What is ADME and how does it fit into drug development?
- Test Systems & Methods
- April 10, 2020
- Madison Knapp, Dr. Brian Ogilvie
The main aim of drug development is to get a compound that has a therapeutic effect into the form of...
How can in vitro and in vivo studies help me understand my drug’s clearance?
- Regulatory Guidance
- March 5, 2020
- Madison Knapp, Dr. Joanna Barbara
Systemic clearance, denoting how much drug is cleared from a volume of blood per unit of time, is of critical...
Timing of In Vitro Studies: Early, Thorough ADME for Your Compound’s Success
- Regulatory Guidance
- February 13, 2020
- Madison Knapp, Dr. Chris Bohl, Greg Loewen
Beyond the need for evidence that a drug works, Food and Drug Administration (FDA) and other regulatory bodies around the...
How Can I Make Sure My Data Meets Regulatory Expectations?
- Regulatory Guidance
- January 10, 2020
- Madison Knapp, Greg Loewen
Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to...
What In Vitro Metabolism and DDI Studies Do I Actually Need?
- Regulatory Guidance
- November 25, 2019
- Madison Knapp, Greg Loewen
Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...
I Have My Data… Now What?
- Consultancy
- October 16, 2019
- Madison Knapp
As a drug moves through the development pipeline, it undergoes a rigorous battery of safety assessments to prove it will...
The FDA has requested follow-up data… how do I fill in the gaps?
- Regulatory Guidance
- October 9, 2019
- Madison Knapp
Because each new drug is unique in characteristics, such as chemical structure, mechanism of action, and physicochemical properties, there can...
Why You Need QWBA for Human Radiolabeled ADME Studies
- Regulatory Guidance
- October 4, 2019
- Satoshi Ito
A quantitative whole body autoradiography (QWBA) study provides data required for Human Radiolabeled ADME Studies1. Quantitative whole body autoradiography (QWBA) is an in...
Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents
- Regulatory Guidance
- June 25, 2019
- Madison Knapp, Dr. Brian Ogilvie
Dr. Ogilvie’s presentation discussed critical literature and case studies which have been published since the FDA’s most recent guidance revision issued in...
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