Related Experiment Video
Updated: May 25, 2026
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Overview of drug discovery and development
Mark A Ator1, John P Mallamo, Michael Williams
1Cephalon, Inc., West Chester, Pennsylvania, USA.
Current Protocols in Pharmacology
|February 2, 2012
Summary
This overview details the drug discovery and development journey, covering target identification, preclinical studies, chemistry, ADME, and regulatory steps like IND and NDA filings through Phase IV trials.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Drug Development and Regulatory Affairs
Background:
- The drug discovery and development process is a complex, multi-stage journey.
- Understanding each phase is critical for successful therapeutic innovation.
Purpose of the Study:
- To provide a comprehensive overview of core activities in drug discovery and development.
- To outline key stages from initial research to post-marketing surveillance.
Main Methods:
- Literature review and synthesis of established drug development pathways.
- Description of key scientific, chemical, and regulatory activities.
Main Results:
- Detailed explanation of target identification, preclinical biology, and chemistry.
- Encompasses pharmacokinetics, metabolism (ADME), and clinical trial phases (I-III).
- Includes regulatory milestones such as Investigational New Drug (IND) and New Drug Application (NDA) filings, and Phase IV post-marketing studies.
Conclusions:
- Successful drug development requires rigorous execution of preclinical and clinical activities.
- Adherence to regulatory guidelines (FDA, EMA, PMDA) is essential for drug approval and market access.
Related Concept Videos
01:26Drug Discovery: Overview
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
01:28Preclinical Development: Overview
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...
01:26Drug Administration and Therapy Phases: Overview
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:28Biopharmaceutics and Pharmacokinetics: Overview
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the appropriate...
01:10In Vitro Drug Release Testing: Overview, Development and Validation
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...