Related Experiment Video

Updated: Jun 12, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

WHO Expert Committee on specifications for pharmaceutical preparations

    World Health Organization Technical Report Series
    |June 22, 2010
    PubMed

    More Related Videos

    A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients11:27

    A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

    Published on: August 9, 2022

    An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment08:59

    An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

    Published on: December 3, 2020

    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...
    Pharmaceutical Equivalents01:26

    Pharmaceutical Equivalents

    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.
    Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

    Biopharmaceutical Factors Influencing Drug Product Design: Overview

    Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
    Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

    Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

    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...
    Drug Dissolution: Requirements and Profile Comparison01:14

    Drug Dissolution: Requirements and Profile Comparison

    The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
    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,...