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Previous major infection outbreaks have shown the importance of timely information about local conditions in guiding support and health care interventions. During the COVID-19 pandemic, UNICEF deve...

This study was conducted to evaluate the current status of the intensive white-leg shrimp farming in earthen system and tarpaulin pond system in Tra Vinh Province by interviewing 110 farmers in Trà Vinh from May to December of 2019. The results of the study showed that an average stocking density in earthen systemand tarpaulin pond system were at 195 and 87 inds/m2 and the number of crops for earthen and tarpaulin ponds are respectively from 1 - 2 crops and 2 - 3 crops per year. The harvested shrimp size and the productivity in tarpaulin ponds (35 inds /kg; 48 tons/ha/crop) were significantly higher than those in the in earthen ponds (58 inds /kg; 12 tons/ha/crop). The net income obtained from the tarpaulin ponds model (1.760 millionVND/ha/crop) was significantly higher than that in the earthen ponds (267 million VND/ha/crop). Food change ratio in tarpaulin ponds was higher than in earthen ponds. The advantages and disadvantages of white - leg shrimp farmers in two models are also mentioned in this report.

The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions.Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.

The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Control (CMC) Community hosted a virtual panel discussion on December 9, 2020, to provide a forum to discuss N-nitrosamine control strategies in the pharmaceutical and biotechnology industries. The panel included staff from the US Food and Drug Administration (FDA) and industry subject matter experts. Meeting topics included acceptable intake levels for nitrosamine impurities, definitions of "acceptable level of risk," water as a contributor in nitrosamine risk assessments, nitrosamine impurity control strategies based upon fate/purge data, early vs. late development assessment expectations, application to oncology programs developed under ICH S9, and Drug Master File (DMF) regulatory expectations. During the meeting, divergence in global health authority expectations was additionally discussed. One of the most important outputs from this AAPS panel discussion was the criticality of continued dialog between industry and health authorities to help understand actual versus perceived risks and provide pragmatic, scientifically justified solutions to ensure patients are provided with an uninterrupted supply of safe medicines based on globally harmonized requirements.

Background In 2016-2017, 68 women in Southern Vietnam had RT-PCR confirmed Zika virus (ZIKV) infection during pregnancy. We report here the outcomes of the pregnancies and the virological analyses related to this outbreak. Methods We collected clinical and epidemiological information from the women who were enrolled in the study. Medical records related to the pregnancy in 2016–2017 were retrieved for those who were not able to be enrolled in the study. Children born to women with ZIKV infection during pregnancy were also enrolled. Serum samples were evaluated for presence of ZIKV antibodies. Phylogenetic analyses were performed on Zika virus genomes sequenced from the 2016–2017 serum samples. Findings Of the 68 pregnancies, 58 were livebirths and 10 were medically terminated. Four of the medical records from cases of fetal demise were able to be retrieved, of which one was consistent with congenital ZIKV infection. Of the 58 women with a livebirth, 21 participated in the follow-up investigation. All but two women had serologic evidence of ZIKV infection. Of the 21 children included in the study (mean age: 30.3 months), 3 had microcephaly at birth. No other clinical abnormalities were reported and no differences in neurodevelopment were observed compared to a control group. Phylogenetic analysis revealed a clade within the ZIKV Asian lineage and branch at the root of samples from the 2013–2014 French Polynesian outbreak. The prM S139N mutation was not observed. Interpretation We have been able to demonstrate a clade within the ZIKV Asian lineage implicated in adverse pregnancy outcomes in Southern Vietnam. Funding INCEPTION project (PIA/ANR-16-CONV-0005) and a grant received from BNP Paribas Simplidon.

BackgroundThe risk factors for scrub typhus in Vietnam remain unknown. Scrub typhus caused byOrientia tsutsugamushioften presents as an undifferentiated febrile illness and remains under appreciated due to the limited availability of diagnostic tests. This tropical rickettsial illness is increasingly recognized as an important cause of non-malaria acute undifferentiated fever in Asia. This study aimed to investigate behavioural and ecological related risk factors of scrub typhus to prevent this potentially life-threatening disease in Vietnam.MethodsWe conducted a clinical hospital-based active surveillance study, and a retrospective residence-enrolment date-age-matched case–control study in Khanh Hoa province, Vietnam, from August 2018 to March 2020. Clinical examinations, polymerase chain reaction and enzyme-linked immunosorbent assay IgM tests were applied to define cases and controls. All enrolled participants filled out a questionnaire including demographic socio-economic status, personal behaviors/protective equipment, habitat connections, land use, and possible exposure to the vector. Multivariable conditional logistic regression was used to define the scrub typhus associated risk factors.ResultsWe identified 44 confirmed cases and matched them with 152 controls. Among cases and controls, the largest age group was the 41–50 years old and males accounted for 61.4% and 42.8%, respectively. There were similarities in demographic characteristics between the two groups, with the exception of occupation. Several factors were significantly associated with acquisition of scrub typhus, including sitting/laying directly on household floor [adjustedOR(aOR) = 4.9, 95%CI:1.6–15.1,P = 0.006], household with poor sanitation/conditions (aOR = 7.9, 95%CI:1.9–32.9,P = 0.005), workplace environment with risk (aOR = 3.0, 95%CI:1.2–7.6,P = 0.020), always observing mice around home (aOR = 3.7, 95%CI:1.4–9.9,P = 0.008), and use of personal protective equipment in the field (aOR = 0.4, 95%CI:0.1–1.1,P = 0.076).ConclusionsEcological and household hygiene-related factors were more associated with scrub typhus infection, than individual-level exposure activities in the hyper-endemic area. These findings support local education and allow people to protect themselves from scrub typhus, especially in areas with limitations in diagnostic capacity.Graphical abstract

Summary Background The Millennium Villages Project (MVP) was a 10 year, multisector, rural development project, initiated in 2005, operating across ten sites in ten sub-Saharan African countries to achieve the Millennium Development Goals (MDGs). In this study, we aimed to estimate the project's impact, target attainment, and on-site spending. Methods In this endline evaluation of the MVP, we retrospectively selected comparison villages that best matched the project villages on possible confounding variables. Cross-sectional survey data on 40 outcomes of interest were collected from both the project and the comparison villages in 2015. Using these data, as well as on-site spending data collected during the project, we estimated project impacts as differences in outcomes between the project and comparison villages; target attainment as differences between project outcomes and prespecified targets; and on-site spending as expenditures reported by communities, donors, governments, and the project. Spending data were not collected in the comparison villages. Findings Averaged across the ten project sites, we found that impact estimates for 30 of 40 outcomes were significant (95% uncertainty intervals [UIs] for these outcomes excluded zero) and favoured the project villages. In particular, substantial effects were seen in agriculture and health, in which some outcomes were roughly one SD better in the project villages than in the comparison villages. The project was estimated to have no significant impact on the consumption-based measures of poverty, but a significant favourable impact on an index of asset ownership. Impacts on nutrition and education outcomes were often inconclusive (95% UIs included zero). Averaging across outcomes within categories, the project had significant favourable impacts on agriculture, nutrition, education, child health, maternal health, HIV and malaria, and water and sanitation. A third of the targets were met in the project sites. Total on-site spending decreased from US$132 per person in the first half of the project (of which $66 was from the MVP) to $109 per person in the second half of the project (of which $25 was from the MVP). Interpretation The MVP had favourable impacts on outcomes in all MDG areas, consistent with an integrated rural development approach. The greatest effects were in agriculture and health, suggesting support for the project's emphasis on agriculture and health systems strengthening. The project conclusively met one third of its targets. Funding The Open Society Foundations, the Islamic Development Bank, and the governments of Japan, South Korea, Mali, Senegal, and Uganda.

Background and Aims: The Asia-Pacific (APAC) Myeloma and Related Diseases Registry (MRDR) collects data on epidemiology, treatment and outcome trends for patients with multiple myeloma (MM) in participating regional countries. Prevalence of MM is expected to continue to increase with ageing populations and improvements in survival. Although some MM data are available for Asia, very few exist at regional level. Generation of 'real world evidence' on practice and outcomes is important to complement data from clinical trials. In the APAC MRDR, regional clinical experts provide local clinical context and registry oversight, and participating hospitals obtain local ethics approval and manage patient recruitment and data collection. Methods: The APAC MRDR prospectively collects observational data on patient characteristics, diagnosis, medical history, treatment (including supportive therapies), and outcomes (overall and progression-free survival, and quality of life using the EQ-5D-5L) on newly diagnosed MM (NDMM), plasma cell leukaemia, plasmacytoma, and MGUS patients via a secure, country-specific, web-based database. Participants are reviewed 4-monthly for a minimum of 2 years. Preliminary data from October 2018 to June 2020 were analysed. Results: 20 hospitals have ethics approval to participate and patient recruitment has commenced at 14 hospitals in Korea, Singapore, and Malaysia. Sites in Taiwan will also start recruitment in 2020, and sites in China have been identified. To date, a total of 469 patients (419 NDMM) have been enrolled, of which, data from 348 (83%) NDMM participants from Korea, Singapore, and Malaysia were available for analysis. Results are presented in Table 1. Summary and Conclusions: The APAC MRDR is now successfully established and expanding. As data mature, these will provide important new information on the epidemiology and treatment of MM across the APAC region, and provide opportunities for regional benchmarking and collaborative research. Disclosures Spencer: Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Sanofi: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding; Secura Bio: Consultancy, Honoraria; Pharmamar: Research Funding; Roche: Honoraria; Servier: Consultancy, Honoraria, Research Funding; HaemaLogiX: Consultancy, Honoraria, Research Funding.

BK DNAemia in renal transplant recipients is a significant cause of allograft dysfunction and can lead to graft loss due to BK polyomavirus-associated nephropathy or to graft rejection due to immunosuppression reduction. Currently, the first-line treatment for BK DNAemia is immunosuppression reduction. Second-line treatment for BK DNAemia has not been well-established. In this report, we present a case of a highly sensitized second-time pediatric renal transplant recipient with severe and persistent BK DNAemia and rising DSA, who was treated with IVIG and subsequently found to have clearance of BK viremia with concomitant reduction in DSA.

This paper presents a case study for assessing the effect of emoticoding during the students’ first encounter with text-based coding interfaces, in which period a student could have a deeply disappointing experience that may lead to “blank page trauma” as well as negative attitude towards the subject. A prototype metaphor-based source code editor was developed using novel human-computer interaction mechanics based on the concept of emoticon-like scripting. Similarly to the use of shortcuts for typing emoticons in social media, visual or textual replacements appear in the proposed text editor when the user types complete valid tokens from a given programming language. Appropriate metaphors can be used in the design of the token replacements so that they are appealing to a particular age, gender, or cultural groups of users. Quantitative analysis of data from 5th-grade students (n = 40) shows that metaphor-based emoticoding improves significantly the students’ performance in terms of syntax recall when they transition from block- to text-based programming in comparison to transitioning without emoticoding.

An American Association of Pharmaceutical Scientists (AAPS) workshop on stability challenges for clinical supplies and commercial distribution of drug product that are not addressed in the International Conference on Harmonization (ICH) Quality documents was held from April 3rd – 4th, 2017 in Rockville, MD. Seventeen subject matter experts (SME), from industry and the Food & Drug Administration (FDA) presented and facilitated the round-table discussions. A total of fifty-five participants that included experienced pharmaceutical scientists, both from small and large pharmaceutical companies and service providers, benefited from the opportunity to interact face-to-face with industry partners and regulatory agency SMEs. The two-day meeting was divided into five major sections to ensure face-to-face interactions and round-table discussions between participants and SMEs: 1) statistical approaches to stability, dissolution, and shelf life testing, 2) microbiological quality of drug products, 3) strategies to support distribution, unplanned excursions, and transportation of drug products, 4) regulatory considerations on stability testing of biologics, and 5) in-use stability during clinical and commercial phases. All in all, this interactive workshop focused on challenges and successes of addressing stability concerns that affect pharmaceutical development, manufacturing, distribution, and use of drug substances/products for which no or limited ICH guidance exists. The interactive meeting provided a unique opportunity to industrial scientists and regulatory agency liaisons to facilitate the discourse on how to address stability challenges that are not addressed in harmonized guidelines: this paper summarizes those discussions.

Microdeletion on the Y chromosome is one of the causes that makes men infertile, accounting for 2-10 % of all infertility cases, and occurs frequently at 3 regions of the Ychromosome long arm namely AZFa, AZFb and AZFc (azoospermia factor). Currently, the diagnosis of microdeletion on the Y chromosome is almost mandatory in institutes and centers for infertility diseases before selecting treatment or assisting methods. To detect microdeletion in AZF, SRY and ZFY regions, the current approach is a Multiplex – PCR assay offering by European Academy of Andrology/European Molecular Genetics Quality Network (EAA/ EMQN). However, the drawback of this method is the PCR products posess similar size and then the DNA electrophoresis bands were very close on gels causing the difficult in diagnosis. Therefore, in this study, we have redesigned primer pairs matching with genes that were recommended by EAA/EMQN but the PCR products are clearly different in sizes, making the DNA electrophoresis bands take apart further to facilitate the diagnosis. Besides, we have also created recombinant plasmids carrying the marker genes for the control sample in kits.

In this paper a new method is proposed for learning computer programming. This method utilizes a set of human-readable graphemes and tokens that interactively replace the grammatical tokens of programming languages, using a concept similar to emoticons in social media. The theoretical framework of the proposed method is discussed in detail and two implementations are presented for the programming language ECMAScript (JavaScript). The results from user testing with undergraduate students show that the proposed technique improves the student’s learning outcomes in terms of syntax recall and logic comprehension, in comparison to traditional source code editors.

This paper studies how the congestion of its editorial process affects an academic journal. In a publishing game played by researchers and editors, we assume that quality screening by editors depends on their ability to properly process the flow of submissions. When too many papers arrive, this ability declines and editors may reject good papers or accept papers with little contribution to scientific knowledge. In this game, a separating equilibrium always exists in which only good researchers submit their papers to the journal. Each paper is accepted and the quality of the journal reaches its highest level. However, when the researchers’ reward for each publication exceeds a given threshold, two hybrid equilibria are also feasible. In these equilibria, authors of low-quality papers submit their papers to the journal and, as the flow of papers exceeds the editors’ capacity of perfect assessment, the selection process becomes imperfect. This creates an opportunity for authors to submit poor quality papers, a behaviour which contributes to the congestion of the editorial process. The various strategies implemented by the editors to oppose congestion are then discussed.

Uniform and large area synthesis of bulk insulating ultrathin films is an important subject toward applications of a surface of three dimensional topological insulators (3D-TIs) in various electronic devices. Here we report epitaxial growth of bulk insulating three dimensional topological insulator (3D-TI) Bi2-xSbxTe3-ySey (BSTS) ultrathin films, ranging from a few quintuple to several hundreds of layaers, on mica in a large-area (1 cm2) via catalyst free physical vapor deposition. These films can nondestructively be exfoliated using deionized water and transferred to various kinds of substrates as desired. The transferred BSTS thin films show good ambipolar characteristics as well as well defined quantum oscillations arising from the topological surface states. Carrier mobility of 2500-5100 cm2(Vs)-1 is comparable to the high quality bulk BSTS single crystal. Moreover, tunable electronic states from the massless to the massive Dirac fermion were observed with a decrease in the film thickness. Both the feasible large area synthesis and the reliable film transfer process can promise that BSTS ultrathin films will pave a route to many applications of 3D-TIs., Comment: 18 page, 4 figures

This article focuses attention on monitoring and evaluation approaches that will help resource managers to manage for change and uncertainty in adaptive co-management (ACM). ACM is a learning-by-doing approach that aims to build flexible community-based natural resource governance systems through collaborative or otherwise participatory means. We describe the framework for monitoring and evaluation that we developed and applied in ten African countries, which includes fixed indicators and measures for co-management performance monitoring, a process evaluation element, a platform for repeat ecological surveillance, and a longitudinal household survey. We comment on the usefulness of this framework, and its applicability to a wide range of geographic contexts. We then present a four step model to assist managers in applying the framework to specific co-management problems. The model suggests a cascade approach to defining key evaluations questions at a systems, network, individual and synthesis level. We illustrate the application of our model and framework by means of a case study of a co-managed agroforestry program in western Kenya.

The goal of this paper is to investigate the influence of parameters of the Bosch deep reactive ion etching (DRIE) process on etched surface profile, sidewall profile and etch rate of micrometre silicon features. By investigating these parameters, we found the conditions to obtain smooth sidewall, high etch rate and balance of chemical and physical etching in the DRIE process. In this paper, the silicon surface was covered by a thin silver patterning, created by lift-off, as a hard mask for the DRIE process. The etched samples were characterised by optical microscopy and mechanical profilometry. The results show smooth sidewall of 136 μm-deep silicon trenches obtained at a high etch rate of 4 μm/min using 5 sccm C4F8, 8 sccm O2 and 24 W of bias power.

The American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products: Product Development and Regulatory Issues was held on 13–14 October 2012 at the McCormick Place in Chicago, IL, USA. The goal of the workshop was to discuss control strategies of chemical and physical changes of active pharmaceutical ingredients (API) and drug products in the drug development process. These changes can affect both the safety and efficacy of drugs; therefore, the ability to rapidly predict and assess the potential for drug product performance changes for impurity formation and the associated safety concerns are important parts of speeding the development of innovative drug therapies without compromising quality. The workshop comprised four different sessions. Each session focused on separate fundamental issues to build a comprehensive understanding of the physical and chemical processes that affect drug impurities and drug degradation products, the control of impurities, and the impact of these factors on safety and regulatory areas. Taken together, this comprehensive understanding is used to achieve a more robust development approach that enables predictability with a concomitant assurance of safety and efficacy. Innovative methodologies for development of effective stability control strategies were also presented. This article summarizes sessions 3 and 4 of the American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products: Product Development and Regulatory Issues and addresses issues of safety considerations of impurities in pharmaceutical products and surveying the impurity landscape. Sessions 1 and 2 of the American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products: Product Development and Regulatory Issues are summarized in Recent Trends in Product Development and Regulatory Issues on Impurities in active Pharmaceutical Ingredient (API) and Drug Products Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms published separately.

The American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products: Product Development and Regulatory Issues was held on October 13–14, 2012 at the McCormick Place in Chicago, IL, USA. The goal of the workshop was to discuss control strategies of chemical and physical changes of active pharmaceutical ingredients (API) and drug products in the drug development process. These changes can affect both the safety and efficacy of drugs; therefore, the ability to rapidly predict and assess the potential for drug product performance changes for impurity formation and the associated safety concerns are important parts of speeding the development of innovative drug therapies. The workshop consisted of four different sessions. Each session focused on separate fundamental issues to build a comprehensive understanding of the physical and chemical processes that impact drug degradation, the control of impurities and the impact of these factors on safety and regulatory areas. Taken together, this comprehensive understanding is used to achieve a more robust development process that enables predictability with a concomitant assurance of safety and efficacy. Innovative methodologies for development of effective stability control strategies were also presented. This article summarizes Sessions 1 and 2 of the American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products: Product Development and Regulatory Issues and addresses of predicting degradation related impurities and impurity considerations for pharmaceutical dosage forms. Sessions 3 and 4 of the American Association for Pharmaceutical Scientists (AAPS) Workshop on Predicting and Monitoring Impurities in API and Drug Products: Product Development and Regulatory Issues are summarized in Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape published separately.

Summary Background Simultaneously addressing multiple Millennium Development Goals (MDGs) has the potential to complement essential health interventions to accelerate gains in child survival. The Millennium Villages project is an integrated multisector approach to rural development operating across diverse sub-Saharan African sites. Our aim was to assess the effects of the project on MDG-related outcomes including child mortality 3 years after implementation and compare these changes to local comparison data. Methods Village sites averaging 35 000 people were selected from rural areas across diverse agroecological zones with high baseline levels of poverty and undernutrition. Starting in 2006, simultaneous investments were made in agriculture, the environment, business development, education, infrastructure, and health in partnership with communities and local governments at an annual projected cost of US$120 per person. We assessed MDG-related progress by monitoring changes 3 years after implementation across Millenium Village sites in nine countries. The primary outcome was the mortality rate of children younger than 5 years of age. To assess plausibility and attribution, we compared changes to reference data gathered from matched randomly selected comparison sites for the mortality rate of children younger than 5 years of age. Analyses were done on a per-protocol basis. This trial is registered with ClinicalTrials.gov, number NCT01125618. Findings Baseline levels of MDG-related spending averaged $27 per head, increasing to $116 by year 3 of which $25 was spent on health. After 3 years, reductions in poverty, food insecurity, stunting, and malaria parasitaemia were reported across nine Millennium Village sites. Access to improved water and sanitation increased, along with coverage for many maternal-child health interventions. Mortality rates in children younger than 5 years of age decreased by 22% in Millennium Village sites relative to baseline (absolute decrease 25 deaths per 1000 livebirths, p=0·015) and 32% relative to matched comparison sites (30 deaths per 1000 livebirths, p=0·033). Interpretation An integrated multisector approach for addressing the MDGs can produce rapid declines in child mortality in the first 3 years of a long-term effort in rural sub-Saharan Africa. Funding UN Human Security Trust Fund, the Lenfest Foundation, Bill & Melinda Gates Foundation, and Becton Dickinson.

Given the myriad of journal titles in economics and business administration, scholars can sometimes target the wrong journal. This paper provides a dynamic analysis of the market for academic publications that brings into the picture this type of informational friction. The key modelling device is a paper-tojournal matching function, similar to the matching function traditional in labor economics. An equilibrium is defined as a situation where both editors and authors implement their optimal publication strategies. The model is then solved for the equilibrium submission fee, desk rejection rate and ratio between the number of editors and the number of authors., L'article propose un modèle d'appariement pour étudier le fonctionnement du marché des publications académiques. Il permet d'analyse le phénomène de "desk-rejection" et propose une explication pour la montée en puissance de droits de soumission d'articles.

The Millennium Villages Project (MVP) is a community-based comprehensive multi-sectoral approach to achieving the Millennium Development Goals (MDGs) in Africa over a five-year period. MVP and Ericsson's Consumer Lab collaborated to investigate the baseline conditions for enhanced connectivity and integrating mobile telephony in MVP sites. It is hypothesized that this will accelerate the achievement of the MDGs through improved communication and availability of information. Using quantitative and qualitative methods, the research team aimed to assess the effects of network strengthening and strategic integration in the context of a rural village in a low-income African country. Four Millennium Village sites were examined for this study on connectivity: Bonsaaso, Ghana; Dertu, Kenya; Ikaram, Nigeria; and Mbola, Tanzania. The survey results from the sites showed common attributes for mobile phone owners but usage trends differed across study sites. Given the results, in three of the four sites, there is a significant market to be explored for voice services to be strengthened and made more easily available in terms of infrastructure and costs. Lessons drawn from these sites can provide us with useful insights into the potential for development and use of mobile phones in the rest of the continent, in addition to providing useful policy implications.

Qualification of analytical instruments has been a complex undertaking, not because the process of qualifying instruments is complex, but because several opinions abound on how to perform a successful qualification. Recently, the United States Pharmacopeia issued General Chapter to provide guidance for Analytical Instrument Qualification (AIQ). The draft chapter has been published in Pharmacopeial Forum (latest in PF 32:6) and has gone through multiple cycles of public comments. The chapter is scheduled to become official in 2008 (USP 31). The purpose of this chapter is to provide general guidance for the qualification of analytical instrument establishing a common terminology and defining roles and responsibilities of those associated with an instrument’s qualification.

This paper considers the search for the best papers by the editors of an academic journal. Editors' search is sequential. At each period, each editor receives one submission from a researcher and has to decide if she accepts or rejects the paper. The editorial board is heterogeneous, some editors being more demanding than others. On the academic side, researchers choose the quality level of their papers in order to maximize their utility function taking as given the composition of the editorial board. We show that three equilibria may occur. When the number of the less demanding editors is high, or if the editors exhibit great differences in their demand for quality, the journal will attract fewer submissions, publish a small number of papers and these papers will be of low quality. When the editorial board is composed by a homogeneous set of very demanding editors, the journal will publish a high number of high quality papers. For some intermediate structure of the board, a situation of multiple equilibria allows a hybrid equilibrium to exist in which the journal receives both good and bad papers. The long run and welfare implications of these equilibria are analyzed.

An AAPS joint face-to-face meeting was held on April 6th, 2016 at MedImmune, Gaithersburg, MD. The meeting was organized by members of the Steering Committees of the Stability Focus Group, the Pharmaceutical Impurities Focus Group and the Chemistry, Manufacturing and Controls (CMC) Statistics Focus Group. Twenty two subject-matter-experts (SME) from the Industry and the Food & Drug Administration (FDA) participated as discussion facilitators or discussion leaders. The total participants reached 65 people representing various sizes of pharmaceutical companies. Four contemporary technical topics on analytical approaches to ensure product quality were selected to be discussed and shared information: (1) Approaches to set release limits and managing method variability; (2) Ensure product quality through lifecycle management; (3) Best practices for predictive stability programs; and (4) ICH Guideline M7 and mutagenic impurities. The purpose of the meeting was to share the best practices in the industry related to the topics; therefore, it is not intended for the participants to reach a consensus on the key issues discussed. This paper summarizes the discussions in the meeting.

The American Association of Pharmaceutical Scientists (AAPS) covers the full range of areas of expertise associated with the resolution of concerns pertaining to drugs and drug products. This editorial highlights the initiatives, issues, and challenges that are the forefront of the pharmaceutical sciences in 2007. It also provides an overview of how these difficult questions are being addressed through the programs and events associated with the AAPS 2007 Annual Meeting that will be held at the San Diego, California, Convention Center from November 11 to 15, 2007.