Christopher Crane
Therapeutic Goods Administration
5 Papers
9 Citations
Christopher Crane is an academic researcher from Therapeutic Goods Administration. The author has contributed to research in topics: Comparator & Voltage. The author has an hindex of 2, co-authored 3 publications.
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Papers
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme.
Alfredo Garcia Arieta,Craig Simon,Gustavo Mendes Lima Santos,Iván Omar Calderón Lojero,Zulema Rodríguez Martínez,Clare Rodrigues,Sang Aeh Park,Ji Myoung Kim,Ryosuke Kuribayashi,Yusuke Okada,Arno Nolting,Chantal Pfäffli,Wen-Yi Hung,Christopher Crane,April C Braddy,Joy Van Oudtshoorn,Diego Alejandro Gutierrez Triana,Mitchell R. Clarke +17 more
TL;DR: There is currently no consensus amongst regulators on the acceptability of foreign comparator products for generic medicines marketed globally.
The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities
E. F. Fernandes,Joy van Oudtshoorn,Andrew Tam,Liliana Carolina Arévalo González,Erwin Guzmán Aurela,Henrike Potthast,Katalina Mettke,Ryosuke Kuribayashi,Kohei Shimojo,Mihoko Kasuga,Lázaro Morales,Zulema Rodríguez,Choongyul Ahn,Eunju Yun,So Hee Kim,Clare Rodrigues,Toh Tiong,Christopher Crane,Chantal Walther,Matthias S Roost,Tzu-Ling Chen,Li-feng Hsu,April C. Braddy,Alfredo García-Arieta,Ivana S. Abalos,Milly Divinsky,Abdulaziz Alsuwyeh,Bader Alzenaidy,Adel Alharf +28 more
- 21 Mar 2024
TL;DR: The BEWGG recommendations for immediate-release solid oral dosage forms provide guidance on the conduct and acceptance criteria for BE studies, highlighting similarities and differences among members.
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A Survey of the Criteria Used for the Selection of Alternative Comparator Products by Participating Regulators and Organizations of the International Pharmaceutical Regulators Programme.
Andrew Tam,Alfredo García-Arieta,Ivana S. Abalos,Eduardo Agostinho Freitas Fernandes,Gustavo Mendes Lima Santos,Zulema Rodríguez Martínez,Milly Divinsky,Rami Kariv,Henrike Potthast,April C. Braddy,Clare Rodrigues,Erwin Guzmán Aurela,Liliana Carolina Arevalo Gonzalez,Diego Gutierres Triana,Ben Jones,Cho Rong Ahn,Hyuna Kim,So-Hee Kim,Ryosuke Kuribayashi,Aya Myoenzono,Kohei Shimojo,Joy Van Oudtshoorn,Cornelia Bigler,Ricarda Meincke,Matthias S Roost,Chantal Walther,Li-feng Hsu,Christopher Crane,Tony Jarman +28 more
TL;DR: A survey conducted within the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP) indicated that the criteria for selecting an alternative comparator product varies as mentioned in this paper .
A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme.
Alfredo Garcia Arieta,Craig Simon,Andrew Tam,Gustavo Mendes Lima Santos,Eduardo Agostinho Freitas Fernandes,Zulema Rodríguez Martínez,Clare Rodrigues,Sang Aeh Park,Jayoung Kim,Kwansoo Kim,Ryosuke Kuribayashi,Aya Myoenzono,Kohei Shimojo,Chantal Walther,Matthias Shona Roost,Wen-Yi Hung,Li-Feng Hsu,Christopher Crane,April C Braddy,Joy Van Oudtshoorn,Diego Alejandro Gutierrez Triana,Erwin Guzmán Aurela,Ben Jones,Henrike Potthast,Ivana Abalos +24 more
TL;DR: The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers for dosage forms such as injectable products may also be allowed if certain criteria are met as mentioned in this paper.
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 Regulators Programme
Joy Van Oudtshoorn,Alfredo García-Arieta,Gustavo Mendes Lima Santos,Christopher Crane,Clare Rodrigues,Craig Simon,Ji Myoung Kim,Sang Aeh Park,Yusuke Okada,Ryosuke Kuribayashi,Chantal Pfäffli,Arno Nolting,Iván Omar Calderón Lojero,Zulema Rodríguez Martínez,Wen-Yi Hung,April C Braddy,Nancy Arciniegas Leal,Diego Alejandro Gutierrez Triana,Mitchell R. Clarke,Peter Bachmann +19 more
TL;DR: This survey compared the criteria for BCS-based biowaivers applied by the participating regulators and organisations and identified several opportunities for greater convergence of regulatory requirements amongst the surveyed jurisdictions.