Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Structure-Activity Relationships and Drug Design01:28

Structure-Activity Relationships and Drug Design

915
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
915
Drug Regulation01:25

Drug Regulation

1.7K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.7K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

157
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
157
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.5K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.5K
Analysis of Population Pharmacokinetic Data01:12

Analysis of Population Pharmacokinetic Data

345
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
345
Pharmacovigilance01:19

Pharmacovigilance

951
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
951

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Rooting Nursing Education in Creation Life: A Whole-Person Framework.

Journal of Christian nursing : a quarterly publication of Nurses Christian Fellowship·2026
Same author

AND-logic MRI contrast by water flux modulation.

Chemical science·2026
Same author

Slowing Down Water: Enhanced and Cation-responsive MRI Contrast.

Angewandte Chemie (International ed. in English)·2026
Same author

Replication-associated base excision repair/single-strand break repair regulates PARG inhibitor response via the PRMT1/PRMT5/ATR axis.

NAR cancer·2026
Same author

Navigating the Future: Considerations for use of Continuous Glucose Monitoring in Diabetes Trials.

Therapeutic innovation & regulatory science·2025
Same author

US Food and Drug Administration Approval Summary: Imetelstat for Selected Patients With Low- to Intermediate-1 Risk Myelodysplastic Syndromes With Transfusion-Dependent Anemia.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology·2025

Related Experiment Video

Updated: Aug 19, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

17.8K

Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER.

Alexei C Ionan1, Jennifer Clark2, James Travis2

  • 1Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, MD, USA. Alexei.Ionan@fda.hhs.gov.

Therapeutic Innovation & Regulatory Science
|December 2, 2022
PubMed
Summary

The U.S. Food and Drug Administration (FDA) explores Bayesian methods as an alternative to traditional significance testing for demonstrating drug and biological product effectiveness. This approach offers a new framework for regulatory approval.

Keywords:
Adaptive designBayesian methodsClinical trialsFDA

More Related Videos

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.7K
Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications
09:39

Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications

Published on: January 27, 2014

12.7K

Related Experiment Videos

Last Updated: Aug 19, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

17.8K
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

9.7K
Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications
09:39

Drug-induced Sensitization of Adenylyl Cyclase: Assay Streamlining and Miniaturization for Small Molecule and siRNA Screening Applications

Published on: January 27, 2014

12.7K

Area of Science:

  • Regulatory Science
  • Biostatistics
  • Pharmaceutical Development

Background:

  • The U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), ensures public health by approving safe and effective drugs and biologics.
  • Null hypothesis significance testing (NHST) is the conventional statistical method for demonstrating treatment efficacy in drug and biological product development.
  • The increasing complexity of clinical trials and the need for more nuanced interpretations of evidence necessitate exploring alternative statistical frameworks.

Purpose of the Study:

  • To discuss the application of the Bayesian framework as an alternative statistical approach in drug and biological product development.
  • To identify specific scenarios and settings where Bayesian methods are particularly suitable for regulatory decision-making.
  • To present recent examples of Bayesian approaches utilized within CDER and CBER.

Main Methods:

  • Review of statistical methodologies employed in drug and biological product evaluation.
  • Discussion of the principles and advantages of the Bayesian statistical framework.
  • Case study analysis of Bayesian applications in regulatory submissions to CDER and CBER.

Main Results:

  • The Bayesian framework offers a flexible and interpretable alternative to NHST for assessing treatment effectiveness.
  • Bayesian methods can be advantageous in situations with prior information, adaptive trial designs, and complex data structures.
  • CDER and CBER have experience with and are increasingly considering Bayesian approaches in their reviews.

Conclusions:

  • The Bayesian framework is a viable and valuable tool for drug and biological product development, complementing traditional statistical methods.
  • Adoption of Bayesian approaches can enhance the efficiency and interpretability of evidence for regulatory approval.
  • Continued exploration and implementation of Bayesian statistics within regulatory agencies like the FDA are expected to advance public health.