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Hashan H.,Saudi Food and Drug Authority | Aljuffali I.,Al Nafal Unit | Aljuffali I.,King Saud University | Patel P.,Center for Innovation in Regulatory Science | And 2 more authors.
Pharmaceutical Medicine | Year: 2016

Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence. Methods: A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore’s Health Sciences Authority, and Australia’s Therapeutic Goods Administration. Results: All four regulatory agencies have established target times for scientific assessment and regulatory review, examine dossier sections in parallel, and separate company response time from overall timing. Additionally, all four agencies have instituted good review practices including standard operating procedures, templates, dossier monitoring, and continuous improvement processes, and assign a high priority to transparency in their relationships with the public, healthcare professionals and industry. Of the four agencies, however, only the SFDA requires a Certificate of Pharmaceutical Product (CPP) at the time of the submission and pricing negotiations before final product approval. Conclusions: To assist the SFDA in its efforts to become a Regional Centre of Excellence, it is suggested that the agency explore a risk stratification approach to select dossiers for verification, abridged, or full reviews; use forms of certification other than the CPP; make pricing negotiations independent to the review process; and introduce a feedback process for the quality of the dossier. © 2015, Springer International Publishing Switzerland.

Al Ghobain M.,King Saud bin Abdulaziz University for Health Sciences | Konbaz M.S.,Saudi Arabian Anti Doping Committee | Almassad A.,Saudi Arabian Anti Doping Committee | Alsultan A.,Saudi Food and Drug Authority | And 2 more authors.
Substance Abuse: Treatment, Prevention, and Policy | Year: 2016

Background: To estimate the lifetime prevalence and address the attitudes and knowledge of using prohibited substances (doping) among sport players in Saudi Arabia. Methods: A cross-sectional survey carried out using systematic random sampling technique among Saudi players of variable sports attending the sport clubs, stadiums, and sport fields (70 sport clubs, 22 types of sports belong to 22 Saudi sport federations were visted in 18 cities from all regions of Saudi Arabia). Results: A total of 1142 male sport players were interviewed with main age of 24. The prevalence of using prohibited substances (doping) was 4.3 %. The main reason for using prohibited substances was to improve performance (69 %). The prevalence of using food supplements (not prohibited) was 38.4 %. Among the players, 30 % of them believe that such behavior is against the spirit of sport while 70 % of the players are aware of punishment against doping. 65 % of players admitted that they received advice on prohibited substances. Higher rate of using prohibited substances (doping) among Saudi players was associated with low education, age below 20 years, previous use of food supplements and lack of punishment awareness. Conclusion: Using prohibited substances (doping) among Saudi sport players is common. Players believe that such use is against the spirit of the sport and they are aware about its punishment, despite this, they are still using prohibited substances. © 2016 Al Ghobain et al.

Ibrahim W.M.,Saudi Food and Drug Authority | AlOmrani A.H.,King Saud University | Yassin A.E.B.,King Saud bin Abdulaziz University for Health Sciences
International Journal of Nanomedicine | Year: 2014

Background: Solid lipid nanoparticles (SLN), novel drug delivery carriers, can be utilized in enhancing both intestinal permeability and dissolution of poorly absorbed drugs. The aim of this work was to enhance the intestinal permeability of sulpiride by loading into SLN. Methods: A unique ultrasonic melt-emulsification method with minimum stress conditions was used for the preparation of SLN. The mixture of the drug and the melted lipids was simply dispersed in an aqueous solution of a surfactant at a temperature that was 10°C higher than the melting points of the lipids using probe sonication, and was then simultaneously dispersed in cold water. Several formulation parameters were optimized, including the drug-to-lipid ratio, and the types of lipids and surfactants used. The produced SLN were evaluated for their particle size and shape, surface charge, entrapment efficiency, crystallinity of the drug and lipids, and the drug release profile. The rat everted sac intestine model was utilized to evaluate the change in intestinal permeability of sulpiride by loading into SLN. Results: The method adopted allowed successful preparation of SLN with a monodispersed particle size of 147.8-298.8 nm. Both scanning electron microscopic and atomic force microscopic images showed uniform spherical particles and confirmed the sizes determined by the light scattering technique. Combination of triglycerides with stearic acid resulted in a marked increase in zeta potential, entrapment efficiency, and drug loading; however, the particle size was increased. The type of surfactant used was critical for particle size, charge, drug loading, and entrapment efficiency. Generally, the in vitro release profile demonstrated by all formulations showed the common biphasic mode with a varying degree of burst release. The everted sac model showed markedly enhanced sulpiride permeability in the case of the SLN-loaded formulation. The in situ results showed a very good correlation with the in vitro release data. Conclusion: Incorporation of sulpiride into SLN results in enhanced intestinal permeability of sulpiride, that may in turn increase overall oral absorption of the drug. The superior attributes of the prepared SLN, specifically the high particle size uniformity and drug loading capacity, is considered novel, especially given the simplicity and modest nature of the sonication method used. © 2014 Ibrahim et al.

Sasich L.D.,Saudi Food and Drug Authority | Sukkari S.R.,1201 North Shore Blvd.
Saudi Pharmaceutical Journal | Year: 2012

On November 18, 2011, the US Food and Drug Administration (US FDA) announced that breast cancer indication for Avastin (bevacizumab) had been withdrawn after concluding that the drug has not been shown to be safe and effective for the treatment of breast cancer. The specific indication that was withdrawn was for the use of bevacizumab in metastatic breast cancer, with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.The US FDAs decision has been met with emotion and confusion among the public and health professionals. The purpose of this article is to review the regulatory history of bevacizumab for breast cancer and to examine the scientific evidence that led to the approval and subsequent withdrawal of this indication. Bevacizumab also provides the opportunity to illustrate the value of free publicly available US FDA reviews that may contain rigorously reviewed unpublished data and analyses and to contrast the decisions made in the US and Europe about bevacizumab and breast cancer. © 2011.

Greenwood K.P.,University of Queensland | Hafiz R.,Saudi Food and Drug Authority | Ware R.S.,University of Queensland | Lambert S.B.,University of Queensland
Vaccine | Year: 2016

Measles is one of the most contagious human diseases. Administration of the live attenuated measles vaccine has substantially reduced childhood mortality and morbidity since its licensure in 1963. The live but attenuated form of the vaccine describes a virus poorly adapted to replicating in human tissue, but with a replication yield sufficient to elicit an immune response for long-term protection. Given the high transmissibility of the wild-type virus and that transmission of other live vaccine viruses has been documented, we conducted a systematic review to establish if there is any evidence of human-to-human transmission of the live attenuated measles vaccine virus. We reviewed 773 articles for genotypic confirmation of a vaccine virus transmitted from a recently vaccinated individual to a susceptible close contact. No evidence of human-to-human transmission of the measles vaccine virus has been reported amongst the thousands of clinical samples genotyped during outbreaks or endemic transmission and individual case studies worldwide. © 2016 Elsevier Ltd.

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