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

Preclinical Development: Overview01:28

Preclinical Development: Overview

5.1K
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...
5.1K
Clinical Trials: Overview01:11

Clinical Trials: Overview

3.7K
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...
3.7K
Drug Discovery: Overview01:26

Drug Discovery: Overview

9.3K
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...
9.3K
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

7
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
7
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

10
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
10
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

887
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
887

You might also read

Related Articles

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

Sort by
Same author

Computational modeling and simulation for medical devices: a summary of the 2024 FDA/MDIC Symposium.

Progress in biomedical engineering (Bristol, England)·2025
Same author

Virtual patients, digital twins and causal disease models: Paving the ground for in silico clinical trials.

Drug discovery today·2023
Same author

Maternal effects as drivers of sibling competition in a parent-offspring conflict context? An experimental test.

Ecology and evolution·2017
Same author

Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives.

Orphanet journal of rare diseases·2014
Same author

BioVision 2007, Immunization for all. 11-14 March 2007, Lyon, France.

IDrugs : the investigational drugs journal·2007

Related Experiment Video

Updated: Oct 8, 2025

Author Spotlight: Standardizing Mouse In Vivo PET Imaging with Body Conforming Molds and Automated Analysis
07:45

Author Spotlight: Standardizing Mouse In Vivo PET Imaging with Body Conforming Molds and Automated Analysis

Published on: October 25, 2024

519

Innovative medicine development.

Valerie Pimpaneau, Emmanuelle Voisin

    Technology and Health Care : Official Journal of the European Society for Engineering and Medicine
    |December 27, 2021
    PubMed
    Summary

    Developing innovative medicines like cell and gene therapies requires integrated strategies and early planning for manufacturing and regulatory approval. This ensures patient access to novel treatments despite challenges like short timelines and small patient populations.

    Keywords:
    Chemistry Manufacturing and Control (CMC)accelerated approvalinnovative drugsregulations

    More Related Videos

    Development of New Therapeutic Applications Using Microfluidics
    08:56

    Development of New Therapeutic Applications Using Microfluidics

    Published on: October 1, 2007

    5.5K
    In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing
    08:04

    In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing

    Published on: May 11, 2021

    3.0K

    Related Experiment Videos

    Last Updated: Oct 8, 2025

    Author Spotlight: Standardizing Mouse In Vivo PET Imaging with Body Conforming Molds and Automated Analysis
    07:45

    Author Spotlight: Standardizing Mouse In Vivo PET Imaging with Body Conforming Molds and Automated Analysis

    Published on: October 25, 2024

    519
    Development of New Therapeutic Applications Using Microfluidics
    08:56

    Development of New Therapeutic Applications Using Microfluidics

    Published on: October 1, 2007

    5.5K
    In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing
    08:04

    In Vitro Three-Dimensional Sprouting Assay of Angiogenesis Using Mouse Embryonic Stem Cells for Vascular Disease Modeling and Drug Testing

    Published on: May 11, 2021

    3.0K

    Area of Science:

    • Pharmaceutical Development
    • Regulatory Science
    • Biotechnology

    Background:

    • The pharmaceutical landscape is rapidly evolving with innovative therapies such as immunotherapy, regenerative medicine, and cell and gene therapy.
    • The COVID-19 pandemic accelerated the adoption of adaptive regulatory pathways for early access to novel treatments and vaccines.
    • Challenges include compressed development timelines, small patient populations, and unique manufacturing, testing, and distribution needs for advanced therapies.

    Discussion:

    • Successful development of innovative medicines necessitates fully integrated strategies spanning research, non-clinical, clinical, and manufacturing stages.
    • Adapted regulatory pathways and proactive market access planning, supported by risk-based approaches, are crucial for navigating complex drug development.
    • The critical path for these therapies involves developing robust manufacturing processes and test methods to ensure quality, safety, and efficacy.

    Key Insights:

    • A strong Chemistry, Manufacturing, and Controls (CMC) strategy must be established early in clinical development for innovative products.
    • Early and consistent interaction with regulatory agencies at key development milestones is vital for risk mitigation and efficient approval.
    • Prioritizing development efforts to support safety and facilitate early patient access is paramount.

    Outlook:

    • Continued adaptation of regulatory frameworks will be essential to accommodate the increasing number of innovative therapies.
    • Advancements in manufacturing technologies and analytical methods will be critical for the successful commercialization of cell and gene therapies.
    • Collaborative efforts between developers, regulators, and healthcare providers will accelerate the delivery of life-changing treatments to patients.