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

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

328
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
328
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

71
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
71
Drug Regulation01:25

Drug Regulation

3.3K
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...
3.3K
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.7K
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...
1.7K
Clinical Trials: Overview01:11

Clinical Trials: Overview

5.4K
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...
5.4K
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

352
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...
352

You might also read

Related Articles

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

Sort by
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2015
Same author

Long-Acting Therapies Will Expand Growth Hormone Deficiency Market.

P & T : a peer-reviewed journal for formulary management·2015
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2015
Same author

Multiple Sclerosis: Progress, but No Cure.

P & T : a peer-reviewed journal for formulary management·2015
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2015
Same author

Exciting Therapies Ahead in Prostate Cancer.

P & T : a peer-reviewed journal for formulary management·2015

Related Experiment Video

Updated: Mar 30, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.7K

Pharmaceutical Approval Update.

Kunj Gohil

    P & T : a Peer-Reviewed Journal for Formulary Management
    |November 5, 2015
    PubMed
    Summary

    Four new medications offer treatment options for high cholesterol, hypoactive sexual desire disorder in women, and two types of chronic hepatitis C virus infections. These advancements provide new therapeutic avenues for patients.

    Area of Science:

    • Pharmacology
    • Hepatology
    • Endocrinology

    Background:

    • High cholesterol, sexual desire disorder, and chronic hepatitis C virus (HCV) infections represent significant public health challenges.
    • Existing treatments may have limitations or be unsuitable for certain patient populations.

    Purpose of the Study:

    • To introduce novel therapeutic agents for specific medical conditions.
    • To expand treatment options for hypercholesterolemia, female sexual dysfunction, and HCV genotypes 3 and 4.

    Main Methods:

    • Review of clinical data and regulatory approvals for alirocumab, flibanserin, daclatasvir, and ombitasvir/paritaprevir/ritonavir.
    • Analysis of efficacy and safety profiles for each medication.

    Main Results:

    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

    10.3K
    Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
    06:34

    Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

    Published on: November 29, 2024

    677

    Related Experiment Videos

    Last Updated: Mar 30, 2026

    Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
    09:30

    Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

    Published on: March 17, 2023

    4.7K
    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

    10.3K
    Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices
    06:34

    Validation of Therapeutic Agent Conjugation to Polyvinyl Alcohol-Coated Medical Devices

    Published on: November 29, 2024

    677
    • Alirocumab (Praluent) demonstrates efficacy in managing high cholesterol.
    • Flibanserin (Addyi) is indicated for hypoactive sexual desire disorder in premenopausal women.
    • Daclatasvir (Daklinza) and ombitasvir/paritaprevir/ritonavir (Technivie) show effectiveness against specific HCV genotypes.

    Conclusions:

    • These newly approved medications offer valuable additions to the clinical armamentarium.
    • Targeted therapies provide improved management strategies for diverse patient needs.