| Description |
1 online resource (158 pages) : illustrations, portraits |
| Physical Medium |
polychrome |
| Description |
text file |
| Note |
"4th international conference, 27-28 September 2011, The Ashling Hotel, Dublin. Maintaining the integrity of drug products through best practice extractables and leachables testing"--Cover. |
| Bibliography |
Includes bibliographical references. |
| Contents |
9781847356642_FrontCover; Contents; Paper 1 Origins of extractables and leachables from polymer products; Paper 2 An update of ELSIE activities; Paper 3 PQRI PODP Extractables & Leachables Working Group: Research project on container closure systems used in parenteral and ophthalmic drug products -- accomplishments and next steps; Paper 4 The simulation study: the replacement of controlled extraction studies for PODP E & L documentation?; Paper 5 Closing the gap between extractables and leachables; Paper 6 Extractables and Leachables: Scientific and Regulatory considerations. |
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Paper 7 Extractables and leachables: UK regulatory perspectivePaper 8 Extractables & Leachables from CCS: Life-Cycle Management and Patient Safety; Paper 9 How to set acceptance criteria for leachable studies: selection and toxicological evaluation of analytical targets; Paper 10 Current extractables/leachables thinking and its impact on the E & L approach of an elastomeric closure supplier; Paper 11 Best practice from a seal manufacturer's view; Paper 12 Extractables/leachables from single-use systems components. |
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Paper 13 Extraction studies on the development of packaging materials for dialysis solutions: presentation of a standard procedure and some resultsPaper 14 Thermodesorption GC/MS as a powerful analytical tool for E & L screenings in pharma or medical grade polymers; Paper 15 Producing processed plastic materials for controlled extractables testing by the ELSIE Materials Working Group; Paper 16 A control strategy for leachables in a dry powder inhaler; Paper 17 Characterisation of drug and drug product related contaminates: when is a leachable not a leachable? |
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Paper 18 Extractables & leachables for medical devices: meeting the 510 (k) requirementsReach For Polymers Advert for all books; 9781847356642_BackCover. |
| Summary |
The examination of extractables and leachables from materials in contact with a drug product or the patient is growing in importance due to increased regulatory scrutiny from organisations such as the Food and Drugs Administration (FDA) and the European Medicines Agency (EMEA). Regulators are concerned with the interaction of various drug delivery devices, such as metered dose and dry powder inhalers (MDI and DPI) and now parenterals and ophthalmics are of increasing interest, as well as pharmaceutical process equipment. Extractables and leachables assessment of all materials and especially fr. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Drugs -- Congresses.
|
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Drugs. |
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Pharmaceutical industry -- Congresses.
|
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Pharmaceutical industry. |
| Genre/Form |
Electronic books.
|
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Conference papers and proceedings.
|
| Subject |
Medication. |
| Genre/Form |
Conference papers and proceedings.
|
| Added Author |
Smithers.
|
| Added Title |
Extractables and Leachables for Pharmaceutical Products 2011 |
| Other Form: |
Print version: ISmithers. Extractables and Leachables for Pharmaceutical Products 2011. Shrewsbury : iSmithers Rapra Publishing, ©2011 9781847356642 |
| ISBN |
9781847356659 (electronic book) |
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1847356656 (electronic book) |
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9781847356642 |
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