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 Experiment Videos

Safety considerations in product development.

A H Hayes1

  • 1EM Pharmaceuticals Inc., Hawthorne, New York, New York.

Drug Safety
|January 1, 1990
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

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

Sort by
Same author

Frequency of haemoglobin desaturation with the use of succinylcholine during rapid sequence induction of anaesthesia.

Acta anaesthesiologica Scandinavica·2001
Same author

Neostigmine antagonism of rocuronium block during anesthesia with sevoflurane, isoflurane or propofol.

Canadian journal of anaesthesia = Journal canadien d'anesthesie·2001
Same author

Postoperative residual block after intermediate-acting neuromuscular blocking drugs.

Anaesthesia·2001
Same author

Sevoflurane--nitrous oxide anaesthesia supplemented with remifentanil: effect on recovery and cognitive function.

Anaesthesia·2001
Same author

The process of drug decision making: perspectives of an FDA Commissioner.

Hospital formulary·1985
Same author

Consumer advertising of prescription drugs.

Pennsylvania medicine·1983
Same journal

Implementation Aspects of a Medicines Shortage Policy Tool: Evidence from Australia's Serious Scarcity Substitution Instruments.

Drug safety·2026
Same journal

Availability and Communication of Risk Management Strategies for Pregnancy Category X Medicines across Australian Medicine Information Sources.

Drug safety·2026
Same journal

The Bidirectionality of Lawyer Reporting Bias in Disproportionality Analysis.

Drug safety·2026
Same journal

Safety of Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: A Longitudinal Analysis.

Drug safety·2026
Same journal

Developing a Hierarchical Algorithm to Identify Pregnancies and Determine Gestational Age from Nationwide Linked Health Data in Taiwan.

Drug safety·2026
Same journal

Safety and Effectiveness of Direct Oral Anticoagulants Versus Low-Molecular-Weight Heparin for Cancer-Associated Thrombosis: A Systematic Review and Meta-analysis.

Drug safety·2026
See all related articles

Drug development is a rigorous process where few compounds reach the market. Evaluating drug safety and efficacy requires considering patient education, societal standards, and unique patient populations for optimal risk-benefit assessment.

Area of Science:

  • Pharmacology and Drug Development
  • Regulatory Science
  • Public Health

Background:

  • Drug development success rates are low, with approximately 1 in 1000 compounds reaching the market.
  • Drug safety is relative, intrinsically linked to efficacy, and societal standards ultimately define acceptable levels.
  • Patient education on disease and medication risks/benefits is crucial for enhancing drug safety.

Purpose of the Study:

  • To examine the complexities of drug development, focusing on safety, efficacy, and societal influences.
  • To advocate for re-evaluation of standard risk-benefit assessment methods for specific diseases and patient groups.
  • To highlight the impact of public pressure on regulatory processes and drug release policies.

Main Methods:

  • Review of drug development processes, including regulatory considerations and public health impacts.

Related Experiment Videos

  • Analysis of factors influencing drug safety, such as patient education, disease context, and drug properties.
  • Consideration of clinical and economic factors in drug development and market release.

    • Main Results:

    • Absolute toxicity is rare; relative toxicity is more common and influenced by numerous factors.
    • Clinical considerations include predicting adverse reactions, managing over-dosage, drug interactions, and patient monitoring.
    • Economic factors like cost, alternative therapies, and liability significantly influence drug development decisions.

    Conclusions:

    • The drug development process, while guided by general principles, involves unique clinical, safety, and toxicity considerations for each drug.
    • Re-evaluating standard risk-benefit assessments may be necessary for specific patient populations or diseases.
    • Societal expectations and public pressure can influence regulatory decisions, necessitating a balanced approach to drug approval and release.