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

343
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,...
343
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

97
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...
97
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

1.9K
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...
1.9K
Drug Regulation01:25

Drug Regulation

3.0K
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...
3.0K
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

369
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...
369
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.7K
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...
4.7K

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·2014
Same author

Pharmaceutical approval update.

P & T : a peer-reviewed journal for formulary management·2014
Same author

Pharmaceutical approval update.

P & T : a peer-reviewed journal for formulary management·2014
Same author

Pharmaceutical approval update.

P & T : a peer-reviewed journal for formulary management·2014
Same author

Pharmaceutical approval update.

P & T : a peer-reviewed journal for formulary management·2014
Same author

Pharmaceutical approval update.

P & T : a peer-reviewed journal for formulary management·2014
Same journal

Formulary Substitution of Proton Pump Inhibitors Based on Acquisition Price: Changes in Usage and Costs of Acid-Suppressant Therapies.

P & T : a peer-reviewed journal for formulary management·2021
Same journal

Is Ciprofloxacin in Combination With Beta-lactam Antibiotics a Recipe for Thrombocytosis?: A Case Report of Thrombocytosis in a Patient Receiving Ciprofloxacin and Ceftriaxone.

P & T : a peer-reviewed journal for formulary management·2021
Same journal

Looking for Trouble: Identifying and Treating Hypotension.

P & T : a peer-reviewed journal for formulary management·2019
Same journal

Research Briefs.

P & T : a peer-reviewed journal for formulary management·2019
Same journal

The Impact of Self-Monitoring Blood Glucose Adherence On Glycemic Goal Attainment in an Indigent Population, With Pharmacy Assistance.

P & T : a peer-reviewed journal for formulary management·2019
Same journal

Continuous Glucose Monitoring: A Review of Available Systems.

P & T : a peer-reviewed journal for formulary management·2019
See all related articles

Related Experiment Video

Updated: May 4, 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

4.4K

Pharmaceutical approval update.

Marvin M Goldenberg

    P & T : a Peer-Reviewed Journal for Formulary Management
    |January 7, 2014
    PubMed
    Summary
    This summary is machine-generated.

    This summary covers Duavee (oral contraceptive), riociguat (Adempas) for pulmonary hypertension, and macitentan (Opsumit) for pulmonary arterial hypertension, highlighting key therapeutic areas.

    More Related Videos

    Primed Mycobacterial Uveitis PMU as a Model for Post-Infectious Uveitis
    10:33

    Primed Mycobacterial Uveitis PMU as a Model for Post-Infectious Uveitis

    Published on: December 17, 2021

    4.3K
    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

    741

    Related Experiment Videos

    Last Updated: May 4, 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

    4.4K
    Primed Mycobacterial Uveitis PMU as a Model for Post-Infectious Uveitis
    10:33

    Primed Mycobacterial Uveitis PMU as a Model for Post-Infectious Uveitis

    Published on: December 17, 2021

    4.3K
    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

    741

    Area of Science:

    • Pharmacology and Therapeutics
    • Cardiovascular Medicine

    Background:

    • Review of novel pharmacological agents for cardiovascular conditions.
    • Focus on treatments for pulmonary hypertension and related disorders.

    Purpose of the Study:

    • To provide an overview of Duavee, an oral contraceptive.
    • To discuss riociguat (Adempas) for treating specific types of pulmonary hypertension.
    • To examine macitentan (Opsumit) in the context of pulmonary arterial hypertension management.

    Main Methods:

    • Literature review and synthesis of existing data.
    • Analysis of drug approvals and indications.
    • Pharmacological profile assessment.

    Main Results:

    • Duavee is an oral contraceptive.
    • Riociguat (Adempas) is indicated for two types of pulmonary hypertension.
    • Macitentan (Opsumit) is approved for pulmonary arterial hypertension.

    Conclusions:

    • These medications represent significant advancements in their respective therapeutic areas.
    • Understanding the specific indications for these drugs is crucial for effective patient care.
    • Further research may explore combination therapies or expanded uses.