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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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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...
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Related Experiment Video

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[Patient database and orphan drug development].

Hiroshi Mizushima1, Mai Tanabe, Yasuhiro Kanatani

  • 1National Institute of Public Health.

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|May 3, 2014
PubMed
Summary

Japan is enhancing its rare disease (RD) initiatives by adopting the Orphanet platform. This aims to improve international collaboration, information sharing, and research for intractable diseases (Nambyo).

Area of Science:

  • Medical Research
  • Public Health Policy

Context:

  • Japan has historically addressed rare diseases (RD) as intractable diseases (Nambyo) since 1972.
  • The definition of Nambyo evolved in 1995 to include rareness, with a prevalence of less than 50,000 in the Japanese population.
  • Current measures for Nambyo, while including research support and medical expense treatment, are not yet comprehensive.

Purpose:

  • To outline Japan's strategic plan to enhance rare disease (RD) management and research.
  • To detail the objectives of establishing Orphanet Japan for improved international collaboration and information dissemination.
  • To highlight the necessity of a patient registry for rare diseases and integration with global efforts.

Summary:

  • Japan is implementing new measures for rare diseases (RD), including joining Orphanet to foster international collaboration and provide up-to-date information in Japanese.

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  • The initiative aims to improve research, information exchange, and network establishment for intractable diseases (Nambyo).
  • Plans include developing a rare disease patient registry and aligning with international efforts like the International Rare Disease Research Consortium (IRDiRC), incorporating patient-reported outcomes.

    • Impact:

    • Expected to enhance international collaboration in rare disease (RD) research and information sharing.
    • Will provide Japanese patients and researchers with access to international, up-to-date rare disease information.
    • Aims to establish a robust patient registry infrastructure, facilitating integrated research and patient advocacy.