CLIA program; simplifying CLIA regulations relating to accreditation, exemption of laboratories under a state

    Federal Register
    |April 20, 1998
    PubMed

    Related Concept Videos

    Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

    Clinically Relevant Drug Product Specifications: Methods of Establishment

    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...
    Interdisciplinary Care: The Health Care Team-II01:18

    Interdisciplinary Care: The Health Care Team-II

    An interdisciplinary team includes many healthcare professionals working together and utilizing their skills, knowledge, and expertise to provide holistic and quality patient care. Here are a few more healthcare professionals.
    Physical Therapist
    A physical therapist (PT) aims to restore function or prevent additional impairment in a patient following an injury or disease. Massage, heat, cold, water, sonar waves, exercises, and electrical stimulation are some treatments used by PTs to treat...
    High-Performance Liquid Chromatography: Introduction01:11

    High-Performance Liquid Chromatography: Introduction

    High-performance liquid chromatography(HPLC), formerly referred to as High-pressure liquid chromatography, is a powerful technique used to separate, identify, and quantify components in complex mixtures. The term "high pressure" refers to using high pressure to push the liquid mobile phase through the tightly packed columns.
    In HPLC, two phases play a critical role in the separation process:
    Hazard Analysis and Critical Control Points (HACCP)01:30

    Hazard Analysis and Critical Control Points (HACCP)

    Hazard Analysis and Critical Control Points (HACCP) is a science-based, preventive system used globally to ensure food safety by identifying, evaluating, and controlling biological, chemical, and physical hazards throughout food production. Originally developed by NASA and the Pillsbury Company for astronaut food, HACCP is now a core component of the Codex Alimentarius.HACCP operates on prerequisite programs—such as Good Manufacturing Practices (GMPs), sanitation procedures, and supplier...
    Bioequivalence studies: Biowaivers01:13

    Bioequivalence studies: Biowaivers

    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...
    High-Performance Liquid Chromatography: Instrumentation00:57

    High-Performance Liquid Chromatography: Instrumentation

    High-performance liquid chromatography, or HPLC, is an analytical technique that separates liquid samples under high pressures. An HPLC instrument consists of glass bottles for storing solvents called mobile phase reservoirs. HPLC-grade solvents are used to maintain high purity, and the dissolved gases are removed using a degasser, such as a vacuum pumping system or sparging with helium. The solvents are then pumped into the analytical column using a screw-driven syringe or reciprocating pumps.