scholarly journals Biowaiver for Immediate and Modified Release Dosage forms Scientific summary of the CSPS workshop

2020 ◽  
Vol 23 ◽  
Author(s):  
Raimar Loebenberg
Keyword(s):  
Dosage Forms ◽  
Pharmaceutical Sciences ◽  
Modified Release ◽  
Canadian Society ◽  
Health Canada

A joint Canadian Society for Pharmaceutical Sciences and Health Canada workshop entitled “Biowaiver for Immediate and Modified Release Dosage forms” was held in Ottawa, November 19th 2015. A summary of all presentations is included.

scholarly journals Subsequent Entry Biologics in Canada: Current State of the Science

2015 ◽  
Vol 18 (2) ◽  
pp. 177 ◽  
Author(s):  
Laszlo Endrenyi ◽  
Fakhreddin Jamali ◽  
Raimar Loebenberg
Keyword(s):  
Product Quality ◽  
Clinical Data ◽  
Pharmaceutical Sciences ◽  
Canadian Society ◽  
Regulatory Requirements ◽  
Safety And Efficacy ◽  
Current State ◽  
Wide Range ◽  
State Of The Science ◽  
Health Canada

The Canadian Society for Pharmaceutical Sciences organized a workshop on the current state of sciences of subsequent entry biologics (SEBs, biosimilars) on December 10th 2014 in the Health Canada location in Ottawa, ON. The day-long workshop provided an opportunity to discuss recent regulatory developments and a wide range of scientific issues related to SEBs. Following a discussion on the differences between the Canadian guidance and those of other countries,  a series of presentations were made that focused on the regulatory requirements with regard to the product quality, methodology, non-clinical and clinical data. In addition, issues of extrapolation from one indication to another, interchangeability and reimbursement  were articulated. It was also highlighted that both the patients and caregivers need to be better informed regarding the safety and efficacy of articulated SEBs.

Applications of Natural Polymeric Materials in Solid Oral Modified-Release Dosage Forms

2015 ◽  
Vol 21 (40) ◽  
pp. 5854-5867 ◽  
Author(s):  
Liang Li ◽  
Xin Zhang ◽  
Xiangqin Gu ◽  
Shirui Mao
Keyword(s):  
Polymeric Materials ◽  
Dosage Forms ◽  
Modified Release

In vitro and in vivo testing and correlation for oral controlled/ modified release dosage forms. report of the 2nd workshop held December 1988, Washington, DC. U.S.A.

1990 ◽  
Vol 14 (1) ◽  
pp. 95-106 ◽  
Author(s):  
Jerome P. Skelly ◽  
Gordon L. Amidon ◽  
William H. Barr ◽  
Leslie Z. Benet ◽  
James E. Carter ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Washington Dc ◽  
Modified Release ◽  
In Vivo Testing

scholarly journals Biosimilars: State of Clinical and Regulatory Science

2017 ◽  
Vol 20 (1) ◽  
pp. 332 ◽  
Author(s):  
Agnes Victoria Klein ◽  
Jian Wang ◽  
Brian G. Feagan ◽  
Mark Omoto
Keyword(s):  
Controlled Release ◽  
International Collaboration ◽  
Pharmaceutical Sciences ◽  
Canadian Society ◽  
Statistical Equivalence ◽  
Product Monograph ◽  
Regulatory Guidelines ◽  
Clinical Considerations ◽  
Biologic Drug ◽  
Switch Study

On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace.

scholarly journals Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Quantitative Composition ◽  
Modified Release ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

scholarly journals Foresight Scanning: Future Directions of Clinical and Pharmaceutical Research

2009 ◽  
Vol 11 (4) ◽  
pp. 108
Author(s):  
Brian C. Foster
Keyword(s):  
New Technologies ◽  
Technology Policy ◽  
Care Delivery ◽  
Pharmaceutical Research ◽  
Pharmaceutical Sciences ◽  
Future Directions ◽  
New Information ◽  
Bayer Healthcare ◽  
Health Canada ◽  
The Impact

Foresight Scanning: Future Directions of Clinical and Pharmaceutical Research. Brian C. Foster, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada ABSTRACT The Canadian Society for Pharmaceutical Sciences Satellite Symposium on Foresight Scanning, May 26 and 27, 2008, Nordegg, Alberta, Canada, focussed on the future directions of clinical and pharmaceutical research. The symposium brought together a group of clinicians, regulatory scientists, researchers and students to examine where clinical, pharmaceutical, and regulatory science might be in 10 to 15 years. Industry, regulatory, analytical, and clinical perspectives were presented and discussed, as well as the impact of exogenous (indirect) and endogenous (direct) change drivers. Unconditional funding was provided by Bayer HealthCare; they had no input on the direction of the meeting or selection of speakers. It was envisioned that the more important endogenous drivers may not be new information or changes in technology, policy, regulation, or health care delivery, but amplification of long-term underlying trends by emergence of new technologies, convergence of existing technologies or new communication and collaboration vehicles such as Web 2.0.

scholarly journals Hot-Melt 3D Extrusion for the Fabrication of Customizable Modified-Release Solid Dosage Forms

Pharmaceutics ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 738 ◽  
Author(s):  
Jaemin Lee ◽  
Chanwoo Song ◽  
Inhwan Noh ◽  
Sangbyeong Song ◽  
Yun-Seok Rhee
Keyword(s):  
Dissolution Rate ◽  
Dosage Form ◽  
Amorphous State ◽  
Dosage Forms ◽  
Modified Release ◽  
Solid Dosage Forms ◽  
Solid Dosage Form ◽  
Solid Dosage ◽  
Enhanced Solubility ◽  
Hot Melt

In this work, modified-release solid dosage forms were fabricated by adjusting geometrical properties of solid dosage forms through hot-melt 3D extrusion (3D HME). Using a 3D printer with air pressure driving HME system, solid dosage forms containing ibuprofen (IBF), polyvinyl pyrrolidone (PVP), and polyethylene glycol (PEG) were printed by simultaneous HME and 3D deposition. Printed solid dosage forms were evaluated for their physicochemical properties, dissolution rates, and floatable behavior. Results revealed that IBF content in the solid dosage form could be individualized by adjusting the volume of solid dosage form. IBF was dispersed as amorphous state with enhanced solubility and dissolution rate in a polymer solid dosage form matrix. Due to absence of a disintegrant, sustained release of IBF from printed solid dosage forms was observed in phosphate buffer at pH 6.8. The dissolution rate of IBF was dependent on geometric properties of the solid dosage form. The dissolution rate of IBF could be modified by merging two different geometries into one solid dosage form. In this study, the 3D HME process showed high reproducibility and accuracy for preparing dosage forms. API dosage and release profile were found to be customizable by modifying or combining 3D modeling.

Preliminary evaluation of thein vitrorelease andin vivoabsorption in rabbits of the modified-release dosage forms

2012 ◽  
Vol 39 (6) ◽  
pp. 889-900 ◽  
Author(s):  
Aleksandra A. Petrovic ◽  
Sasa M. Petricevic ◽  
Slavica M. Ristic ◽  
Svetlana R. Ibric ◽  
Slobodanka S. Simic ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Preliminary Evaluation ◽  
Modified Release
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