A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

March 28th, 2019 by aveciapharma

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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Posted in: Pharmaceutical Online

Nitto Avecia Pharma Services Addresses Questions About Extractables And Leachables Studies

March 20th, 2019 by aveciapharma

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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Posted in: Outsourced Pharma

Extractables And Leachables Studies Support Single-Use Systems

March 12th, 2019 by aveciapharma

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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Posted in: Pharmaceutical Online

Extractables And Leachables Studies Support Single-Use Systems

February 27th, 2019 by aveciapharma

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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Posted in: Outsourced Pharma

3 Steps To Better Extractables & Leachables Studies

February 20th, 2019 by aveciapharma

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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Posted in: Outsourced Pharma, Pharmaceutical Online

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

January 22nd, 2019 by aveciapharma

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...

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Posted in: Pharmaceutical Online

A Systematic Approach To Extractables And Leachables: A Review Of Guidance From The Industry

January 16th, 2019 by aveciapharma

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...

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Posted in: BioProcess Online, Outsourced Pharma


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