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A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators...
by
Garcia Arieta, Alfredo
,
Simon, Craig
,
Lima Santos, Gustavo Mendes
,
Calderón Lojero, Iván Omar
,
Rodríguez Martínez, Zulema
,
Rodrigues, Clare
,
Park, Sang Aeh
,
Kim, Ji Myoung
,
Kuribayashi, Ryosuke
,
Okada, Yusuke
,
Nolting, Arno
,
Pfäffli, Chantal
,
Hung, Wen-Yi
,
Crane, Christopher
,
Braddy, April C
,
Van Oudtshoorn, Joy
,
Gutierrez Triana, Diego
,
Clarke, Mitch
Published in
Journal of pharmacy & pharmaceutical sciences
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A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulat...
by
Van Oudtshoorn, Joy Elizabeth
,
García-Arieta, Alfredo
,
Santos, Gustavo Mendes Lima
,
Crane, Christopher
,
Rodrigues, Clare
,
Simon, Craig
,
Kim, Ji Myoung
,
Park, Sang Aeh
,
Okada, Yusuke
,
Kuribayashi, Ryosuke
,
Pfäffli, Chantal
,
Nolting, Arno
,
Lojero, Iván Omar Calderón
,
Martínez, Zulema Rodríguez
,
Hung, Wen-Yi
,
Braddy, April C
,
Leal, Nancy Arciniegas
,
Triana, Diego Gutierrez
,
Clarke, Mitch
,
Bachmann, Peter
Published in
Journal of pharmacy & pharmaceutical sciences
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The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and...
by
Fernandes, Eduardo Agostinho Freitas
,
van Oudtshoorn, Joy
,
Tam, Andrew
,
González, Liliana Carolina Arévalo
,
Aurela, Erwin Guzmán
,
Potthast, Henrike
,
Mettke, Katalina
,
Kuribayashi, Ryosuke
,
Shimojo, Kohei
,
Kasuga, Miho
,
Morales, Lázaro
,
Rodríguez, Zulema
,
Jones, Ben
,
Ahn, Choongyul
,
Yun, Eunju
,
Kim, So Hee
,
Rodrigues, Clare
,
Tiong, Toh
,
Crane, Christopher
,
Walther, Chantal
,
Roost, Matthias S
,
Chen, Tzu-Ling
,
Hsu, Li-Feng
,
Braddy, April C
,
García-Arieta, Alfredo
,
Abalos, Ivana
,
Divinsky, Milly
,
Alsuwyeh, Abdulaziz
,
Alzenaidy, Bader
,
Alharf, Adel
Published in
Journal of pharmacy & pharmaceutical sciences
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The Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and...
by
Crane, Christopher
,
Santos, Gustavo Mendes Lima
,
Fernandes, Eduardo Agostinho Freitas
,
Simon, Craig
,
Tam, Andrew
,
Triana, Diego Gutierrez
,
Potthast, Henrike
,
Kuribayashi, Ryosuke
,
Okada, Yusuke
,
Myoenzono, Aya
,
Calderon, Ivan Omar
,
Rodriguez, Zulema
,
Jones, Ben
,
Park, Sang Aeh
,
Eum, So Young
,
Rodrigues, Clare
,
Van Oudsthoorn, Joy
,
Nolting, Arno
,
Walther, Chantal
,
Roost, Matthias S
,
Hung, Wen-Yi
,
Braddy, April C
,
Garcia-Arieta, Alfredo
Published in
Journal of pharmacy & pharmaceutical sciences
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