Evaluation of Excipient Risk in BCS Class I and III Biowaivers

The objective of this review article is to summarize literature data pertinent to potential excipient effects on intestinal drug permeability and transit. Despite the use of excipients in drug products for decades, considerable research efforts have been directed towards evaluating their potential effects on drug bioavailability. Potential excipient concerns stem from drug formulation changes (e.g., scale-up and post-approval changes, development of a new generic product). Regulatory agencies have established in vivo bioequivalence standards and, as a result, may waive the in vivo requirement, known as a biowaiver, for some oral products. Biowaiver acceptance criteria are based on the in vitro characterization of the drug substance and drug product using the Biopharmaceutics Classification System (BCS). Various regulatory guidance documents have been issued regarding BCS-based biowaivers, such that the current FDA guidance is more restrictive than prior guidance, specifically about excipient risk. In particular, sugar alcohols have been identified as potential absorption-modifying excipients. These biowaivers and excipient risks are discussed here.

Bioprocess Control: Current Progress and Future Perspectives

Typical bioprocess comprises of different unit operations wherein a near optimal environment is required for cells to grow, divide, and synthesize the desired product. However, bioprocess control caters to unique challenges that arise due to non-linearity, variability, and complexity of biotech processes. This article presents a review of modern control strategies employed in bioprocessing. Conventional control strategies (open loop, closed loop) along with modern control schemes such as fuzzy logic, model predictive control, adaptive control and neural network-based control are illustrated, and their effectiveness is highlighted. Furthermore, it is elucidated that bioprocess control is more than just automation, and includes aspects such as system architecture, software applications, hardware, and interfaces, all of which are optimized and compiled as per demand. This needs to be accomplished while keeping process requirement, production cost, market value of product, regulatory constraints, and data acquisition requirements in our purview. This article aims to offer an overview of the current best practices in bioprocess control, monitoring, and automation.

Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution?

The pace of scientific progress over the past several decades within the biological, drug development, and the digital realm has been remarkable. The’omics revolution has enabled a better understanding of the biological basis of disease, unlocking the possibility of new products such as gene and cell therapies which offer novel patient centric solutions. Innovative approaches to clinical trial designs promise greater efficiency, and in recent years, scientific collaborations, and consortia have been developing novel approaches to leverage new sources of evidence such as real-world data, patient experience data, and biomarker data. Alongside this there have been great strides in digital innovation. Cloud computing has become mainstream and the internet of things and blockchain technology have become a reality. These examples of transformation stand in sharp contrast to the current inefficient approach for regulatory submission, review, and approval of medicinal products. This process has not fundamentally changed since the beginning of medicine regulation in the late 1960s. Fortunately, progressive initiatives are emerging that will enrich and streamline regulatory decision making and deliver patient centric therapies, if they are successful in transforming the current transactional construct and harnessing scientific and technological advances. Such a radical transformation will not be simple for both regulatory authorities and company sponsors, nor will progress be linear. We examine the shortcomings of the current system with its entrenched and variable business processes, offer examples of progress as catalysts for change, and make the case for a new cloud based model. To optimize navigation toward this reality we identify implications and regulatory design questions which must be addressed. We conclude that a new model is possible and is slowly emerging through cumulative change initiatives that question, challenge, and redesign best practices, roles, and responsibilities, and that this must be combined with adaptation of behaviors and acquisition of new skills.

Measuring Progress of Regulatory Convergence and Cooperation Among Asia–Pacific Economic Cooperation (APEC) Member Economies in the Context of the COVID-19 Pandemic

Purpose Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes—which can be achieved in part through regulatory convergence and cooperation—both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19. Methods The Asia–Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC’s 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence. Results This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation. Conclusions Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19.

Challenges of small-scale standalone solar energy supply in parts of Lagos via 39 years dataset

The adoption of solar energy as a sustainable clean type of energy can be seen globally by the patronage of solar devices. However, the high patronage photovoltaic (PV) module by the small-scale standalone user may be mitigated by the recent high maintenance cost via PV module damages by UV radiation. This study analyzed thirty-nine years (1980-2018) shortwave dataset in the tropics to chart the way forward for PV user, manufacturer, and regulatory organizations. It was observed that there is an increase in shortwave radiation in recent times that has led to more damages to PV modules. However, there is a statistical possibility that there may be lower shortwave radiation in the next decade, thereby reducing PV module damage. It is recommended that PV manufacture should modify the PV polymeric to shield the PV modules from UV radiation damage. Based on this research’s finding, it is recommended that product regulatory organizations develop a new technique to monitor PV modules.

64 E-cigarette and Vaporizer-related Burn Injury: Demographics and Injury Patterns

Introduction E-cigarettes and vaporizers (E-cigs) have seen a dramatic surge in popularity. The Centers for Disease Control now estimates that 1 in 4 United States (US) high school students use E-cigs. Recent recognition of E-cig-related lung injury has garnered significant attention. However, relatively little is known about E-cig-related burn injuries, which are often due to battery explosion and liquid ignition. The objective of this study was to characterize population demographics and injury patterns associated with E-cig burns. Methods A retrospective review of all patients presenting with E-cig-related cutaneous burn injury to a verified US burn center between January 2015 and August 2019 was performed using an institutional database. In addition, media reports covering the same mechanism of injury and date range were collected using databases for the National Electronic Injury Surveillance System, American Nonsmokers’ Rights Foundation, and international news outlets. Demographic data and injury metrics were recorded. Results 309 international media reports and 30 institutional cases of E-cig-related burn injuries were identified. Media-reported injuries varied with respect to geographic location: US-185, United Kingdom-35, Canada-6, all other countries-8, unclear-75. Annual incidence peaked in 2016 in media reports (2019-19, 2018–61, 2017–68, 2016–106, 2015–55) and institutional records (2019-3, 2018-5, 2017-6, 2016-16, 2015-0). Injuries predominantly involved men in both media (Male 75.7%, Female 13.9%, unknown 10.4%) and institutional (Male 93.3%, Female 6.7%) datasets. Average age was 31.0 years (media) and 30.3 years (institutional). The institutional data revealed an average TBSA of 3.5% (range 1–8.5%), an average length of stay of 3.8 days (range 0–14 days), and a median number of operations of 1 (range 0–2). 90% (n=27) of patients required inpatient admission and one patient required mechanical ventilation. On admission, 58% (n=14) of patients screened positive for cannabis use. A ranking of anatomic regions by frequency of involvement was consistent between datasets: lower extremity > hands > head/neck > torso > groin. Mortality rates were also similar: 1.62% (media) and 0% (institutional). Conclusions E-cig-related burns are non-trivial injuries, most of which require inpatient admission, operative management, and substantial resource use. They disproportionately affect young men and burns often involve sensitive areas like the hands and face. Applicability of Research to Practice Combined with rising popularity, lax regulation, proliferation of counterfeit products, and associated lung injury, E-cig-related burns represent an evolving health threat. This study highlights the importance of reporting injuries to consumer product regulatory agencies and the need for further research into the causes and consequences of E-cig explosion.

Bank Crisis: the Current Scenario of Merger and Acquisition in India

Banks are the pillars that support the financial structure of a modern economic system. Their successes and screw ups are inextricably connected to the Indian economy. Indian banks have additionally had their proportion of troubles with consequences for the country. Bank runs, awful debt, etc, are a number of the persistent issues confronted with the aid of banking structures globally. The study focus on how the banking crisis impact on the economy. These days, the banking system in India has been beset through a big terrible debt crisis, which is crimping credit score to the productive sectors of our economy. This weakening in financial institution credit score has dampening impact on domestic funding, leading to subdued increase in employment and Gross domestic Product. Regulatory interventions and oversight of central banks, government aid and stakeholder involvement arise widely a success in preserving stability, even though punctuated with obtrusive disasters. However, it may be the best time to reconsider the primary design of the banking device and restructure it by addressing the flaws in its present day shape through mergers and acquisitions. Furthermore the paper concludes that merger is a helpful strategy through this bank can expand their operations and the overall growth.