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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Reading Scientific Services Ltd. (RSSL) is a British company that provides scientific analysis, consultancy, product development and training to the global food, drink, healthcare, pharmaceutical, biopharmaceutical and consumer goods sectors. It has been inspected by regulatory authorities including the U.S. Food and Drug Administration, the ...
With stability testing, pharmaceutical industry inspects the quality of drug substances and drug products as per the guidelines outlined by US Food and Drug Administration and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to make sure that they retained the quality over the period of time.
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
Chemical stability testing evaluates the long-term resistance of materials and products to chemical degradation. This form of testing is crucial for determining how substances react to environmental factors such as heat, humidity, oxidation, and exposure to aggressive chemicals.
The European Committee for Food Contact Materials and Articles (CD-P-MCA) [37] is tasked with developing and strengthening harmonised measures that supplement EU and national legislation to ensure the safety of packaging, containers, utensils and other materials and articles for food contact. It is supported by two subordinate bodies: the ...
Repeated Dose 90-Day Oral Toxicity Study in Non-Rodents 410: Repeated Dose Dermal Toxicity: 21/28-day Study 411: Subchronic Dermal Toxicity: 90-day Study 412: Subacute Inhalation Toxicity: 28-Day Study 413: Subchronic Inhalation Toxicity: 90-day Study 414: Prenatal Development Toxicity Study 415: One-Generation Reproduction Toxicity Study 416
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.