March 28th, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services
Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it is...
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Tags: extractables and leachables, presentations, case studies
Posted in: Pharmaceutical Online
March 20th, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Nitto Avecia Pharma Services
Extractable and leachable safety assessments can be some of the most challenging review issues in an FDA application, according to an agency official.1 That is because they require a coordinated effort between review staff from Chemistry,...
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Tags: extractables and leachables, presentations, Xtalks
Posted in: Outsourced Pharma
March 12th, 2019 by Aryo A. Nikopour
By Aryo Nikopour, Senior Vice President, Scientific & Technical Services, Nitto Avecia Pharma Services
Single-use systems have gained a surprisingly strong foothold in the drug manufacturing market thanks to improved extractables and leachables studies.
Not long ago, concerns about leachables...
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Tags: extractables and leachables, case studies
Posted in: Pharmaceutical Online
February 27th, 2019 by Aryo A. Nikopour
By Aryo Nikopour, Senior Vice President, Scientific & Technical Services, Nitto Avecia Pharma Services
Single-use systems have gained a surprisingly strong foothold in the drug manufacturing market thanks to improved extractables and leachables studies.
Not long ago, concerns about leachables...
Read Full Story »
Tags: extractables and leachables, case studies
Posted in: Outsourced Pharma
February 20th, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Nitto Avecia Pharma Services
There is no shortage of guidance for conducting extractables and leachables studies.
For instance, U.S. Pharmacopeia and the Product Quality Research Institute (PQRI) offer separate and useful recommendations.
However, an ideal approach...
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Tags: extractables and leachables, case studies
Posted in: Outsourced Pharma, Pharmaceutical Online
January 22nd, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services
Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it...
Read Full Story »
Tags: extractables and leachables, presentations, case studies
Posted in: Pharmaceutical Online
January 16th, 2019 by Aryo A. Nikopour
By Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services, Nitto Avecia Pharma Services
Aryo A. Nikopour, Senior Vice President of Scientific and Technical Services with Nitto Avecia Pharma Services, discusses the basic definitions of extractables and leachables and why it is important...
Read Full Story »
Tags: extractables and leachables, presentations, compliance and guidelines
Posted in: BioProcess Online, Outsourced Pharma