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As per available reports about 3 Conferences, 15 symposiums are presently dedicated exclusively to Parenteral leachables.
Parenteral leachables are chemical entities, each organic and inorganic, that migrate from elements of a instrumentality closure system or device into a drug product over the course of its shelf-life. Parenteral leachables are usually present in drug product matrices as advanced mixtures at trace levels relative to the active pharmaceutical ingredient (API). Leacheables testing capabilities embody evaluations for:
• Drug Delivery Systems
• instrumentality Closure Systems
etc.. The sensible thanks to conduct a restrictive parenteral leachables study is as a part of a restrictive stability study. The substances of concern and to be controlled will have been identified via toxicological consideration of the ex-tractables data. Conduct parenteral leachables studies (during drug product stability testing) supported ways used for controlled extractables studies. once attainable establish a correlation between extractables & leachables–Could be attainable to eliminate leachables testing and develop routine extractables testing. Parenteral leachables studies give qualitative and quantitative knowledge to make a comprehensive profile of removable elements and verify the extent to that such elements truly leach and doubtless contaminate a drug substance or drug product.
Leachable analytes is also compared to established in-house standards generated from:
–Knowledge of CCS element composition
–Additional info from CCS suppliers
Leachable impurities generally reported in units of ppm ought to be known once attainable (e.g., CAS written record variety, structure, name) to permit materia medica assessment.
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Scope and Importance:
It is important that the suitable packaging selected or the device design will preserve the integrity of the drug product or medical device. These systems may include:
These studies identify organic and inorganic materials released or migrated from packaging components. The FDA typically requests that potential impurities are identified and then monitored throughout the life of the product. However there are many variables that determine the type of extractable and leachable study to perform and to what degree a product is tested. EAG scientists are adept at navigating this uncharted territory, applying fresh and novel thinking to extractable and leachable study designs.
The global revenue for single use technology reached $1.4 billion and $1.7 billion in 2013 and 2014, respectively. This market is expected to grow at a compound annual growth rate (CAGR) of 11.7% to nearly $3.0 billion for the period 2014-2019.
International symposium and workshops:
International conference on polymers in medical devices for parenteral drug administration
Workshop on Assuring quality and performance of sustained and controlled release parenterals.
Symposium on Impact of New-Generation Parenteral Lipid Emulsions in Pediatric Nutrition
PDA/FDA Joint Regulatory Conference, 13-16 Sept 2010, Washington DC.
The new FDA Approach to Analytical Methods Validation of Drugs and Biopharmaceuticals November 2014, Berlin, Germany
IPAC RS Workshop on Extractables and Leachables 2011 March.
PDA Extractables and Leachables Nov 6-8, 2007, Bethesda, MD.
PharmaEd’s Extractables and Leachables 2010, May 2010, San Francisco
Extractables and Leachables for Pharmaceuticals Products, 14-15 Sept 2010 (London).
Workshop on Trends in Manufacturing of Parenteral Pharmaceuticals Date: 26.11.2014 - 26.11.2014
Relevant Society and Associations
1. Parenteral Drug Associations
2. American Society for Parenteral and Enteral Nutrition
3. Australian Medical Association
4. American Pharmacists Association
5. American Association of Pharmaceutical Scientists
6. International Academy of Compounding Pharmacists
7. European Medicines Agency
8. American College of Clinical Pharmacy
9. European Society for Clinical Nutrition and Metabolism
10.American Society for Nutrition
2. Accredo Therapeutics
3. Actelion Pharmaceuticals US, Inc
4. Bayer HealthCare
5. CRITICAL CARE
6. Cané Medical Technology
7. CVS Caremark
9. Fairview Specialty Pharmacy
This page will be updated regularly.
This page was last updated on 11th Sep, 2015
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