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Purpose: To review in vitro testing and simulation platforms that are in current use to predict in vivo performances of generic products as well as other situations to provide evidence for biowaiver and support drug formulations development. Methods: Pubmed and Google Scholar databases were used to review published literature over the past 10 years. The terms used were “simulation AND bioequivalence” and “modeling AND bioequivalence” in the title field of databases, followed by screening, and then reviewing. Results: A total of 22 research papers were reviewed. Computer simulation using software such as GastroPlus™, PK-Sim® and SimCyp® find applications in drug modeling. Considering the wide use of optimization for in silico predictions to fit observed data, a careful review of publications is required to validate the reliability of these platforms. For immediate release (IR) drug products belonging to the Biopharmaceutics Classification System (BCS) classes I and III, difference factor (ƒ1) and similarity factor (ƒ2) are calculated from the in vitro dissolution data of drug formulations to support biowaiver; however, this method can be more discriminatory and may not be useful for all dissolution profiles. Conclusions: Computer simulation platforms need to improve their mechanistic physiologically based pharmacokinetic (PBPK) modeling, and if prospectively validated within a small percentage of error from the observed clinical data, they can be valuable tools in bioequivalence (BE) testing and formulation development.

Background: Tobacco use is the major cause of preventable morbidity and mortality. The main objectives of this study were to identify smokers willing to participate in quit smoking campaigns using social media and to identify smoking habits of everyday smokers in Al Ain City, United Arab Emirates (UAE). Research Design and Methods: Everyday smokers from Al Ain city of the UAE were surveyed in different locations of the city including malls and specialized tobacco-selling shops. They were interviewed using a semi-structured survey and the information was recorded by one assessor. The information gathered included type and frequency of tobacco use, smoking history and habits, quitting history, desire to quit, and the preferred communication platform. Result: A total of 412 regular adult smokers were interviewed in which the majority (95%) reported first smoking at or before the age of 28 years. Participants were mainly UAE nationals (33.7%), Egyptians (14.1%), Syrians (12.9%), and Jordanians (10.9%). Manufactured cigarettes were the main form of tobacco consumption (59.5%), and smoking was mainly solitary (56.3%) and at home (26.3%) and coffee shops (24.9%). The majority of interviewed subjects (76.7%; 95% confidence interval [CI]: 72.4%–80.5%) expressed their interest to quit smoking in the future and 55.3% (95% CI: 50.5%–60.2%) were ready to get involved immediately in a smoking cessation program. Of those, 80.3% (95% CI: 74.6%–84.9%) preferred WhatsApp for receiving smoking cessation motivational education. Conclusion: The majority of smokers started at younger ages, which warrant the age of smoking restriction to be raised to 29 years instead of 18 years by the health authority. Everyday smokers were aware of the potentially hazardous effects of tobacco smoking and many were willing to accept help to quit smoking that involves the use of WhatsApp.