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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Rural health centers are specialized care facilities in remote locations with very few medical personnel. The primary care providers who run the centers are mostly Registered Nurse Practitioners. Here, emergency treatment is provided to critically ill or injured patients before they are transferred to the closest hospital. Fortunately, due to advancement in technology, many rural healthcare facilities and professionals have easy access to diagnostic and treatment...
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Specialized care settings or centers are situated in convenient locations within the community and offer care to a specific group or population. They consist of daycare facilities, mental health facilities, rural health facilities, educational institutions, industries, shelters for the homeless, and rehabilitation facilities.
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Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...
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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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Priorities for the Priority Review Voucher.

David B Ridley1

  • 1Duke University, Durham, North Carolina.

The American Journal of Tropical Medicine and Hygiene
|August 31, 2016
PubMed
Summary

The U.S. Priority Review Voucher program incentivizes drug development for rare diseases. Analysis shows program strengths, weaknesses, and suggests legislative improvements are needed.

Area of Science:

  • Health Economics
  • Pharmaceutical Policy
  • Drug Development

Background:

  • The U.S. Congress established the Priority Review Voucher (PRV) program in 2007.
  • This initiative aims to stimulate the creation of medicines for neglected tropical diseases and rare pediatric conditions.
  • Approved drugs for these conditions grant developers a voucher for priority review of a subsequent drug.

Purpose of the Study:

  • To evaluate the effectiveness and identify areas for improvement in the Priority Review Voucher program.
  • To analyze recent experiences and outcomes associated with the voucher program.
  • To inform potential legislative modifications for the program.

Main Methods:

  • Review of the U.S. Priority Review Voucher program's legislative history and operational framework.

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  • Analysis of data on voucher utilization and financial transactions up to 2016.
  • Assessment of the program's strengths and weaknesses based on available evidence.

    • Main Results:

    • As of 2016, four vouchers had been utilized.
    • The average sale price for these vouchers reached $200 million.
    • The program demonstrates both successes and challenges in incentivizing drug development.

    Conclusions:

    • The Priority Review Voucher program has potential but requires adjustments.
    • Legislative changes are necessary to optimize the program's impact on neglected disease drug development.
    • Further evaluation is recommended to ensure the program's long-term success and efficiency.