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 Abstracts of poster presentations at the 2021 virtual annual of the Canadian Society for Pharmaceutical Sciences.

2021 ◽  
Vol 24 ◽  
Author(s):  
Kristine Warman
Keyword(s):  
Controlled Release ◽  
Infectious Diseases ◽  
Nobel Laureate ◽  
Pharmaceutical Sciences ◽  
Canadian Society ◽  
University Of Alberta ◽  
Medical Microbiology ◽  
Pharmaceutical Society ◽  
Poster Presentations

In 2021, the Canadian Society for Pharmaceutical Sciences (CSPS) partnered with he Pharmaceutical Society of Japan (PSJ) and the Canadian Chapter of Controlled Release Society (CC-CRS) and presented its annual matting in virtual style. Keynote speakers included Professor Michael Houghton – 2020 Nobel Laureate, Director of Li Ka Shing Applied Virology Institute (LKSAVI), Professor, Department of Medical Microbiology & Immunology, University of Alberta and Professor Yoshiharu Matsuura, Director, Center for Infectious Diseases Education and Research (CIDER), Osaka University, Japan.

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.

Chitosan: A Multifunctional Polymer

2017 ◽  
Vol 3 (1) ◽  
pp. 256-276
Author(s):  
Rupinder Kaur ◽  
Ujjwal Nautiyal ◽  
Alok Semwal
Keyword(s):  
Drug Delivery ◽  
Controlled Release ◽  
Oral Delivery ◽  
Chemical Reactivity ◽  
Research Effort ◽  
Biological Properties ◽  
Pharmaceutical Sciences ◽  
Natural Polysaccharide ◽  
Potential Applications ◽  
Novel Drug

Chitin is the most important natural polysaccharide after cellulose, found in crustaceous shell or in cell walls of fungi. Chitosan, one of the natural multifunctional polymers, due to its unique and versatile biological properties is regarded as a useful compound in medical and pharmaceutical technology. In recent times chitosan has been far and wide used as a popular formulation excipient due to its inimitable characteristics in the field of pharmaceutical sciences as binding, disintegrating, stabilizing, suspending, tablet coating, and film forming material. Recently, considerable research effort has been made in order to develop safe and efficient chitosan products. Chitosan has been comprehensively investigated for its suitability for its controlled release characteristics in various studies. Oral delivery of genes and peptides by means of different formulations based on chitosan is also investigated in various examinations by the capability of its absorption and penetration enhancing properties. It is possessing tremendous mucoadhesive and inherent anti-microbial properties, so that it can be used as a carrier for novel drug delivery. In addition to the above mentioned reasons, tailoring the controlled release and to improve the therapeutic efficacy of the low molecular weight drug compounds can also be achieved by this polymer and moreover in combination with various polymers is feasible due its compatibility i.e. low chemical reactivity. This brief editorial epitomizes the potential applications of chitosan in novel drug delivery systems.

scholarly journals Comparative Evaluation of HPMC, PVA and Gelatin as Matrices for Controlled Release Drug Delivery

1970 ◽  
Vol 2 (1) ◽  
pp. 51-55
Author(s):  
Mohammad Anwarul Basher ◽  
Abul Kalam Lutful Kabir ◽  
Mohammad Musarraf Hussain ◽  
Mir Mohammad Abdullah Al Mamun
Keyword(s):  
Controlled Release ◽  
Drug Release ◽  
Diclofenac Sodium ◽  
Magnesium Stearate ◽  
Matrix Tablets ◽  
Matrix Tablet ◽  
Pharmaceutical Sciences ◽  
Drug Release Profile ◽  
Compression Process ◽  
Model Drug

The present study was undertaken to compare three different polymeric gums- HPMC, PVA and gelatin as controlled release matrices. Diclofenac sodium, a potent analgesic, was used as the model drug. Different ratio of HPMC, PVA and gelatin were incorporated into the lactose loaded Diclofenac tablet to explore their impact on drug release. Matrix tablets of Diclofenac were prepared by using individual polymer with magnesium stearate and aerosil by direct compression process at 5 ton pressure. The release of drug from these matrices was studied over 2 hrs in acidic media where insignificant release was observed. Then, the same formulations were studied over 8 hours in buffer media of pH 6.8 at a temperature of 37± 0.5°C. Statistically significant differences in drug release profile was found among the tablets prepared from different matrices. The study revealed that the average % release of drug from different types of polymer loaded matrix tablet varied with the ratio of different polymers. Among the three polymers, PVA showed best dissolution pattern. A comparison of Higuchi curve and bi-exponential curve was also performed. Key words: HPMC; PVA; Gelatin; Controlled release; Diclofenac DOI: 10.3329/sjps.v2i1.5816Stamford Journal of Pharmaceutical Sciences Vol.2(1) 2009: 51-55

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.

Controlled Release Drugs in Overdose Clinical Considerations

Drug Safety ◽  
1995 ◽  
Vol 12 (1) ◽  
pp. 73-84 ◽  
Author(s):  
Nicholas A. Buckley ◽  
Andrew H. Dawson ◽  
David A. Reith
Keyword(s):  
Controlled Release ◽  
Clinical Considerations
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