Generic substitution and prescription drug prices : economic effects of state drug product selection laws /

Item 535.

Pharmacy benefit managers : early results on ventures with drug manufacturers : report to the Honorable Ron Wyden, House of Representatives /

"B-257388"--P. 1.

Simultaneous kinetic spectrophotometric determination of norfloxacin and rifampicin in pharmaceutical formulation and human urine samples by use of chemometrics approaches

A kinetic spectrophotometric method with aid of chemometrics is proposed for the simultaneous determination of norfloxacin and rifampicin in mixtures. The proposed method was applied for the simultaneous determination of these two compounds in pharmaceutical formulation and human urine samples, and the results obtained are similar to those obtained by high performance liquid chromatography.

Multicomponent kinetic spectrophotometric determination of pefloxacin and norfloxacin in pharmaceutical preparations and human plasma samples with the aid of chemometrics

A spectrophotometric method for the simultaneous determination of the important pharmaceuticals, pefloxacin and its structurally similar metabolite, norfloxacin, is described for the first time. The analysis is based on the monitoring of a kinetic spectrophotometric reaction of the two analytes with potassium permanganate as the oxidant. The measurement of the reaction process followed the absorbance decrease of potassium permanganate at 526 nm, and the accompanying increase of the product, potassium manganate, at 608 nm. It was essential to use multivariate calibrations to overcome severe spectral overlaps and similarities in reaction kinetics. Calibration curves for the individual analytes showed linear relationships over the concentration ranges of 1.0–11.5 mg L−1 at 526 and 608 nm for pefloxacin, and 0.15–1.8 mg L−1 at 526 and 608 nm for norfloxacin. Various multivariate calibration models were applied, at the two analytical wavelengths, for the simultaneous prediction of the two analytes including classical least squares (CLS), principal component regression (PCR), partial least squares (PLS), radial basis function-artificial neural network (RBF-ANN) and principal component-radial basis function-artificial neural network (PC-RBF-ANN). PLS and PC-RBF-ANN calibrations with the data collected at 526 nm, were the preferred methods—%RPET not, vert, similar 5, and LODs for pefloxacin and norfloxacin of 0.36 and 0.06 mg L−1, respectively. Then, the proposed method was applied successfully for the simultaneous determination of pefloxacin and norfloxacin present in pharmaceutical and human plasma samples. The results compared well with those from the alternative analysis by HPLC.

Internal audit department characteristics/activities and audit fees : some evidence from Hong Kong firms

This study provides preliminary support for the notion that internal audit function assists in reducing external audit effort and fees. Data on internal audit characteristics and activities are obtained from survey respondents of Hong Kong companies and audit fee model data are acquired from their annual reports. The results of this study suggest that the external auditor of firms in Hong Kong rely on the internal audit function and subsequently charge a lower fee. Lower external audit fees are associated with a larger internal audit department and certain activities carried out by the internal audit. Specifically, lower external audit fees are associated with more internal audit effort spent on activities relating to financial statements, systems development and maintenance, operating efficiency and effectiveness, fraud investigations and unlimited access to internal auditors’ working papers. The results of this study suggest that the contribution of the internal audit may substitute for some substantive external auditing processes and lower monitoring costs.

Termination fees in a ‘bright line’ jurisdiction

We seek to statistically inform the debate regarding the Australian Takeovers Panel’s ‘bright line’ policy towards break fees. Based on 313 takeovers from 2002 to 2006, 85 involving break fees, we find post-bid competition to be unrelated to break fee usage and inversely related to bid success. We also find that break fee usage has a detrimental effect on shareholder wealth as measured by both the final bid premium and abnormal returns. Therefore, although break fees appear to be neither anticompetitive nor coercive within the Australian context, they do appear to have had a deleterious effect on shareholder wealth.

Book review: "English for telecoms and information technology" by T. Ricca and M. Duckworth; "English for legal professionals" by A. Frost; "English for the pharmaceutical industry" by M. Buchler, K. Jaehnig, G. Matzig, and T. Weindler; "English for cabin crews" by S. Ellis and L. Lansford; and "English for negotiating" by C. Lafond, S. Vine, and B. Welch.

This review examines five books in the Oxford Business English Express Series, including "English for telecoms and information technology" by T. Ricca and M. Duckworth; "English for legal professionals" by A. Frost; "English for the pharmaceutical industry" by M. Buchler, K. Jaehnig, G. Matzig, and T. Weindler; "English for cabin crews" by S. Ellis and L. Lansford; and "English for negotiating" by C. Lafond, S. Vine, and B. Welch.

Take care with 'care and consideration', and keep an eye on fees for reasons

In Southwell v Jackson [2012] QDC 65, McGill DCJ examined a number of rules in Chapter 17A of the Uniform Civil Procedure Rules 1999 (Qld) dealing with costs assessment as well as relevant provisions of the Legal Profession Act 2007 (Qld). This article looks at issues of general principle raised by the decision.

Impact fees and new housing cost: A comparative analysis of the empirical models

Developers and policy makers are consistently at odds over the debate as to whether impact fees increase house prices. This debate continues despite the extensive body of theoretical and empirical international literature that discusses the passing on to home buyers of impact fees, and the corresponding increase to housing prices. In attempting to quantify this impact, over a dozen empirical studies have been carried out in the US and Canada since the 1980’s. However the methodologies used vary greatly, as do the results. Despite similar infrastructure funding policies in numerous developed countries, no such empirical works exist outside of the US/Canada. The purpose of this research is to analyse the existing econometric models in order to identify, compare and contrast the theoretical bases, methodologies, key assumptions and findings of each. This research will assist in identifying if further model development is required and/or whether any of these models have external validity and are readily transferable outside of the US. The findings conclude that there is very little explicit rationale behind the various model selections and that significant model deficiencies appear still to exist.

Australia and its impact fees

Australia is a country, which has much of its legislative roots in its Commonwealth heritage. However due to its size and nature, its planning and development processes are more aligned to countries such as the United States. This paper will present an overview of the Australian urban land market, its infrastructure funding mechanisms (property taxes) and current provisions in each of Australia’s seven States and Territories that provide for developer contributions for local infrastructure (impact fees).

An analysis of Australia's legal regime for imposing liability on manufacturers of pharmaceutical drugs

Following a trial in June 2009 where the Federal Court heard submissions regarding whether Merck Sharpe and Dohme Australia should be held liable for an increased risk of cardiovascular conditions noted in patients who had taken the anti-inflammatory drug Vioxx, a judgment was handed down against MSDA in March 2010. MSDA appealed to the Full Federal Court, where they were successful. Special leave to appeal to the High Court of Australia was rejected in May 2012. This article will examine the themes raised in the trial judgment and the appropriateness of Australia’s statutory consumer protection regime through the lens of pharmaceutical drug injuries and side effects.

The global public health issue of pharmaceutical waste : what role for pharmacists?

Purpose Pharmaceuticals have played an important role in improving the quality of life of the human population in modern times. However, it must also be acknowledged that both the production and use of pharmaceuticals have a significant, negative impact on the environment and consequently, a negative impact on the health of humans and wildlife. This negative impact is due to the embedded carbon in pharmaceuticals' manufacture and distribution and the waste generated in their manufacture, consumption and disposal. Pharmaceutical waste is comprised of contaminated waste (unwanted pharmaceuticals and their original containers) and non-contaminated waste (non-hazardous packaging waste). The paper aims to discuss these issues. Design/methodology/approach The article is a literature review. Findings The article identified a gap in the literature around pharmacist attitudes and behaviour toward the environmentally responsible handling of pharmaceutical waste. Originality/value Pharmacists, with their professional commitment to the quality use of medicines and their active participation in the medicines management pathway, already play an important role in the more sustainable use of pharmaceuticals. Even so, they have the potential to play an even greater role with the environmentally responsible disposal of pharmaceutical waste (including packaging waste) and the education of other health professionals and the general public on this topic.

Audit fees and asset securitization risks

The thesis investigates “where were the auditors in asset securitizations”, a criticism of the audit profession before and after the onset of the global financial crisis (GFC). Asset securitizations increase audit complexity and audit risks, which are expected to increase audit fees. Using US bank holding company data from 2003 to 2009, this study examines the association between asset securitization risks and audit fees, and its changes during the global financial crisis. The main test is based on an ordinary least squares (OLS) model, which is adapted from the Fields et al. (2004) bank audit fee model. I employ a principal components analysis to address high correlations among asset securitization risks. Individual securitization risks are also separately tested. A suite of sensitivity tests indicate the results are robust. These include model alterations, sample variations, further controls in the tests, and correcting for the securitizer self-selection problem. A partial least squares (PLS) path modelling methodology is introduced as a separate test, which allows for high intercorrelations, self-selection correction, and sequential order hypotheses in one simultaneous model. The PLS results are consistent with the main results. The study finds significant and positive associations between securitization risks and audit fees. After the commencement of the global financial crisis in 2007, there was an increased focus on the role of audits on asset securitization risks resulting from bank failures; therefore I expect that auditors would become more sensitive to bank asset securitization risks after the commencement of the crisis. I find that auditors appear to focus on different aspects of asset securitization risks during the crisis and that auditors appear to charge a GFC premium for banks. Overall, the results support the view that auditors consider asset securitization risks and market changes, and adjust their audit effort and risk considerations accordingly.

Aligning off-balance sheet risk, on-balance sheet risk and audit fees: a PLS path modelling analysis

This study focuses on using the partial least squares (PLS) path modelling technique in archival auditing research by replicating the data and research questions from prior bank audit fee studies. PLS path modelling allows for inter-correlations among audit fee determinants by establishing latent constructs and multiple relationship paths in one simultaneous PLS path model. Endogeneity concerns about auditor choice can also be addressed with PLS path modelling. With a sample of US bank holding companies for the period 2003-2009, we examine the associations among on-balance sheet financial risks, off-balance sheet risks and audit fees, and also address the pervasive client size effect, and the effect of the self-selection of auditors. The results endorse the dominating effect of size on audit fees, both directly and indirectly via its impacts on other audit fee determinants. By simultaneously considering the self-selection of auditors, we still find audit fee premiums on Big N auditors, which is the second important factor on audit fee determination. On-balance-sheet financial risk measures in terms of capital adequacy, loan composition, earnings and asset quality performance have positive impacts on audit fees. After allowing for the positive influence of on-balance sheet financial risks and entity size on off-balance sheet risk, the off-balance sheet risk measure, SECRISK, is still positively associated with bank audit fees, both before and after the onset of the financial crisis. The consistent results from this study compared with prior literature provide supporting evidence and enhance confidence on the application of this new research technique in archival accounting studies.