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[1] 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.
Version 2.0 of eCTD – an upgrade over the original CTD – was finalized on February 12, 2002, [1] and version 3.0 was finalized on October 8 of the same year. [2] As of August 2016, the most current version is 3.2.2, released on July 16, 2008. [3] A Draft Implementation Guide (DIG) for version 4.0 of eCTD was released in August 2012. [4]
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.
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles. [1]
Particle size distribution/ fibre length and diameter distributions 111: Hydrolysis as a function of pH 112: Dissociation constants in water 113: Screening test for thermal stability and stability in air 114: Viscosity of liquids 115: Surface tension of aqueous solutions: 116: Fat solubility of solid and liquid substances 117
The ASEAN Charter [1] is a constituent instrument of the Association of Southeast Asian Nations (ASEAN). It was adopted at the 13th ASEAN Summit in November 2007. [2]The intention to draft the Charter had been formally proposed at the 11th ASEAN Summit held in December 2005 in Kuala Lumpur, Malaysia.