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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Cancer Prevention02:59

Cancer Prevention

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Several factors can increase the risk of cancer in an individual. About 50% of cancer cases can be prevented by adopting a healthy lifestyle, regular exercise, eating healthy, and following a modest cancer prevention diet. Epidemiological studies have consistently shown that populations with vegetable and fruit-rich diets have reduced the incidence of cancer. On the other hand, populations who have a diet rich in animal fat, red meat, junk food, or high calories are predisposed to cancer.
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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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...
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Prevention of Further Absorption of Poison01:14

Prevention of Further Absorption of Poison

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In cases of acute poisoning, the primary objective is to prevent further absorption of the toxic substance into the body. Immediate interventions using various decontamination techniques targeting the gastrointestinal (GI) tract can achieve this. Decontamination is crucial to prevent poison from entering the systemic circulation, which involves washing affected areas with water and mild soap and removing contaminated clothing. Once external decontamination is done, attention must be turned to...
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Preventive Healthcare Services01:30

Preventive Healthcare Services

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Preventive healthcare services keep people healthy via frequent check-ups, screening, and counseling. They primarily aid in disease prevention rather than treating an acute or chronic illness. Preventive treatment also keeps individuals productive and energetic, allowing them to work well into their retirement years. Examples of preventive care services include:
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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

189
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Related Experiment Video

Updated: Feb 12, 2026

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
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How to prevent the next Marathon Pharmaceuticals.

Frank S David1, Richa Dixit1

  • 1Pharmagellan LLC, Milton, MA, , 02186, USA.

F1000Research
|April 12, 2018
PubMed
Summary

Drug companies are exploiting regulatory loopholes to raise prices on therapies like Emflaza (deflazacort). Current policies may not prevent future price hikes on newly approved drugs.

Area of Science:

  • Pharmaceutical policy
  • Drug pricing
  • Regulatory affairs

Background:

  • Recent exploitation of U.S. regulatory policies by drug companies to increase prices of therapies.
  • Marathon Pharmaceuticals' Emflaza (deflazacort) case is unique as the drug was previously unavailable in the U.S.

Purpose of the Study:

  • Analyze the unique aspects of the Emflaza case compared to other drug price increases.
  • Assess the potential for similar situations in the future.
  • Explore legislative and administrative strategies to prevent such occurrences.

Main Methods:

  • Comparative analysis of Emflaza case with other drug pricing incidents.
  • Review of existing U.S. regulatory policies.
  • Identification and evaluation of potential legislative and administrative solutions.
Keywords:
FDAorphanpharmaceuticalpriceregulation

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Main Results:

  • Emflaza's situation differs from typical drug price hikes due to its novel U.S. market entry.
  • Existing policies targeting price increases on established drugs are insufficient to address Emflaza-like scenarios.
  • Further legislative and administrative actions are needed to prevent similar drug pricing issues.

Conclusions:

  • The Emflaza case highlights a gap in current regulations regarding price manipulation of newly approved drugs.
  • Future drug pricing strategies may exploit this regulatory loophole.
  • Proactive policy interventions are necessary to ensure fair drug pricing and prevent exploitation.