Výsledky vyhledávání - "Maik Jornitz"

Autor: Maik Jornitz

Publikováno v: Handbook of Validation in Pharmaceutical Processes ISBN: 9781003163138
Handbook of Validation in Pharmaceutical Processes

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::bfe9b542190fa4f12a0afeaec121b4be
https://doi.org/10.1201/9781003163138-47

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Test Process and Results of Potential Masking of Sterilizing-Grade Filters

Autor: Maik Jornitz, Leesa McBurnie, Stephanie S Ferrante, Brian Joseph, Mandar Dixit

Publikováno v: PDA journal of pharmaceutical science and technology. 74(5)

Pre-use/post-sterilization integrity testing (PUPSIT) has been a widely debated topic for the last several years. To a large extent, the debate is because of the fact that scientific data were not available to provide additional clarity that could in

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8954615957469e7596c57e4917483c14
https://pubmed.ncbi.nlm.nih.gov/32467175

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PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities

Autor: Lisa Skeens, Morten Munk, Marcello Colao, Melissa Seymour, Ursula Busse, Julia Edwards, Mihaela Simianu, Maik Jornitz, Emma Ramnarine, Anders Vinther

Publikováno v: PDA Journal of Pharmaceutical Science and Technology. 71:163-169

Changes occur throughout a product's commercial life—changes in raw materials, manufacturing equipment, processes, sites, analytical methods, and suppliers. A product Marketing Authorization Holder (MAH) can introduce manufacturing changes as part

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3deda6accf6937920e1287713f6b154a
https://doi.org/10.5731/pdajpst.2016.007492

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PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?

Autor: Rich Levy, Anders Vinther, Suzanne Kiani, Lisa Skeens, Marcello Colao, Ursula Busse, Kevin O'Donnel, Julia Edwards, Denyse Baker, Karolyn Gale, Mihaela Simianu, Morten Munk, Kara Follman, Kassidy Good, Melissa Seymour, Maik Jornitz, Emma Ramnarine

Publikováno v: PDA Journal of Pharmaceutical Science and Technology. 71:421-427

PDA's PAC iAM (Post-Approval Change: Innovation for Availability of Medicines) program has been established with the objective to identify, assess, and address current barriers to implementation of post-approval changes (PACs) that are intended to en

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e66df7f1caa9ae01d6e74750f9e81092
https://doi.org/10.5731/pdajpst.2017.008219

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