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Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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 (CHF).
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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,...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Drug Regulation01:25

Drug Regulation

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

Drug Products: Biologics, Biosimilars and Interchangeables

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...

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Updated: Jun 12, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Formulary decisions: then and now.

Bradley A Boucher1

  • 1Department of Clinical Pharmacy, University of Tennessee Health Science Center, Memphis, Tennessee 38163-0001, USA. bboucher@uthsc.edu

Pharmacotherapy
|May 27, 2010
PubMed
Summary

Hospital formularies are evolving beyond simple drug lists to complex cost-management tools. Pharmacists must consider safety protocols, risk evaluation and mitigation strategies (REMS), and potential penalties when making formulary decisions.

Area of Science:

  • Health Administration
  • Pharmacoeconomics
  • Drug Management

Background:

  • Hospital formularies have evolved from basic drug lists to integral components of healthcare administration.
  • The scope of formulary management has expanded significantly due to increased regulatory scrutiny and safety considerations.

Purpose of the Study:

  • To highlight the evolving complexities of hospital formulary decision-making.
  • To emphasize the need for a broader assessment beyond cost-effectiveness and acquisition prices.

Main Methods:

  • Review of current trends in drug management and institutional policies.
  • Analysis of factors influencing formulary decisions, including regulatory requirements and safety protocols.

Main Results:

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Improving IV Insulin Administration in a Community Hospital
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Improving IV Insulin Administration in a Community Hospital

Published on: June 11, 2012

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Last Updated: Jun 12, 2026

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

Improving IV Insulin Administration in a Community Hospital
12:08

Improving IV Insulin Administration in a Community Hospital

Published on: June 11, 2012

  • Formulary decisions now encompass a wide range of financial and operational considerations.
  • Costs associated with black-box warnings, safety protocols, and risk evaluation and mitigation strategies (REMS) significantly impact drug choices.

Conclusions:

  • Pharmacists face a complex environment requiring comprehensive evaluation of formulary agents.
  • Future formulary considerations may include "never events" and their financial implications, necessitating strategic planning.