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 In this section:

                Regulatory Science in Action

Regulatory Science in Action

                        CDER Scientists in their Own Words
          Dr. Woodcock on Regulatory Science Home
          Drugs
          Science and Research | Drugs
          Regulatory Science in Action
          Impact StoriesRegulatory Science in Action Impact Stories
  
  	
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    PrintTo illustrate the unique value of CDER’s regulatory science investments we have developed a series of “impact stories” that describe recent  advances by our researchers and the impacts of these discoveries on drug development and the public health.

Bioequivalence testing for highly variable drugs


**An adaptive trial design for testing the bioequivalence of generics of highly variable drugs**

December 15, 2023


Pharmaceutical Drugs


**Biorelevant Pediatric Dissolution Methodology**

December 11, 2023


Woman working at desk monitoring multiple screens


Gadolinium-based contrast agents for MRI: safety in pregnancy

August 15, 2023


lamotrigine


FDA shows generic lamotrigine extended-release tablets are bioequivalent to innovator drug in fully replicated crossover bioequivalence study

July 26, 2023


BBB QSAR Model


New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability

April 19, 2023


Impact Story AI Thumbnail


Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics

February 8, 2023


hands holding cell phone


Prescription drug promotion in online character space limited (CSL) communication

December 27, 2022


Scientists using tablet in lab


Assessing the Impact of Opioid Overdose and Opioid Antagonist Dosing to Support Medical Product Development

December 22, 2022


Impact Story ASD


Formulating Drug Products for Optimized Absorption: Elucidating Amorphous Solid Dispersions

August 30, 2022


Women pointing at figure on monitor screen


Designing Sound Clinical Trials That Incorporate Real-World Data

August 19, 2022


OTS Adult to Pediatric


Applying the Non-inferiority Paradigm to Assess Exposure-Response and Dosing Comparisons Between Pediatric and Adult Patients

August 16, 2022


Impact Story In Vitro Test Factors


Effects of Realistic In Vitro Test Factors on the Aerosol Properties of Metered-Dose Inhalers

May 23, 2022


Raman scattering


Through-Container Quantitative Screening of Hand Sanitizers

March 18, 2022


Diclofenac


How Modeling Was Used to Support the FDA Approval of a Topical Generic Drug Product

December 1, 2021


Injectable suspension impact story thumbnail from OTS


New In Vitro Methods to Understand and Mitigate Clinical Variability Associated with Injectable Suspensions

December 2, 2021


Impact Story - Pediatric dosing


Improving Dose Selection In Children through Better Estimates of Renal Function

November 19, 2021


Impact Story - Antibiotics


Exploiting Real-World Data to Optimize the Use of Antibiotics

November 9, 2021


Microphysiology


Three-Dimensional (3D) Cell Culture (Microphysiological) Platforms as Drug Development Tools

August 23, 2021


Manufacturuing


Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins

August 20, 2021


Drug Advertising


Advancing Our Understanding of How Drug Promotion Influences Consumers and Health Care Providers

August 19, 2021


Pregnant Woman holding a pill and a glass of water


Physiologically Based Pharmacokinetic Modeling of Sertraline Dosing in Pregnancy

August 16, 2021


A man holding nasal spray canister in one hand, and inserting canister tip into nose.


How computational analysis of a 3D mucociliary clearance model can help predict drug uptake and lead to more generic nasal drug products

April 28, 2021


cyber brain


A New Approach to Pharmacometrics: Recurrent Neural Networks for Modeling Drug Exposure and Drug Response

April 26, 2021


Person sitting at desk typing on laptop with clipboard and stethoscope nearby


Public Posting of a Comprehensive Surrogate Endpoint Table for CDER- and CBER-Regulated Products

December 11, 2020


Impact Story - Metastatic Breast Cancer


Use of Cyclin-Dependent Kinase 4/6 Inhibitor with Hormonal Therapy in Metastatic Breast Cancer—Efficacy in Patient Subgroups

November 16, 2020


Impact Story - Schizophrenia


Improving the Design of Clinical Trials of Drugs to Treat Schizophrenia

November 10, 2020


ANDAs Impact Story


A CDER Study of Factors that May Predict the Likelihood of Generic Drug Marketing Applications

October 28, 2020


Figure 2. Comparison of DOM and ROM statistical analyses.


CDER Statistical Studies Innovate Measures of Adhesion to Assess Generic Products

June 23, 2020


Modeling Tools Could Modernize Generic Drug Development

June 2, 2020


CDER Assessment of Drug Impurity Mutagenicity by Quantitative Structure-Activity Relationship Modeling

May 15, 2020


Improved Assessment of Cardiotoxic Risk in Drug Candidates: The Comprehensive in vitro Proarrhythmia Assay

March 6, 2020


Using innovative statistical approaches to provide the most reliable treatment outcomes information to patients and clinicians

June 10, 2019


Determining the Clinical Benefit of Treatment Beyond Progression with Immune Checkpoint Inhibitors

February 21, 2019


Supporting Drug Development Through Physiologically Based Pharmacokinetic Modeling

February 21, 2019


Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics

December 4, 2018


Evaluating the Potential of Microengineered Human Cellular Systems to Predict Drug Effects in the Clinic

October 5, 2018


A Flexible Clinical Trial Design Suitable for Emerging Disease Outbreaks

August 13, 2018


Capturing Patient Experience Through Deep Learning

August 13, 2018


Preclinical Research to Achieve Safer Prescribing of Psychoactive Therapeutics for Patients Who Use Opioids

August 9, 2018


Developing the Tools to Evaluate Complex Drug Products: Peptides

October 2, 2017


Finding a Better Test for Predicting the Risk Drugs Pose to the Heart

June 22, 2017


Regulatory Science is Strengthening U.S. Drug Product Manufacturing

June 22, 2017


Developing New Ways to Evaluate Bioequivalence for Topical Drugs

September 22, 2017


Addressing Concerns About the Quality of Generic Drugs for Treating Epilepsy

September 22, 2017





Helping to Better Communicate the Risks and Benefits in Prescription Drug Advertising

September 22, 2017

                                                                                  Content current as of:
      12/14/2023
              
              
Regulated Product(s)
		 DrugsRegulatory Science in Action

          
                        CDER Scientists in their Own Words
          Dr. Woodcock on Regulatory Science
 
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