Social Class and Delinquent Behavior in a National Youth Panel: 1976–1980

This article addresses the question of whether or not a more adequate measure of self-reported delinquency applied to a representative national sample would reveal class differences in r l e l i m that have not been found in earlier self-report studies. The methodological criticisms of earlier self-report measures are reviewed, a new self-report measure is described, annual sex-by-class-specific prevalence and incidence rates based on this measure are presented for a national youth panel for the years 1976 through 1980, and the implications of the class findings are discussed. Class differences in both prevalence and incidence are found for serious offenses. For males, class differences are also found in the incidence of nonserious offenses and global delinquency Class differences are more pervasive and stronger when using an incidence as opposed to a prevalence measure. Criticisms of earlier self report measures appear Justified, calling into Question conclusions about the distribution of delinquency in the adolescent population which are based on prim self-report data.     

The Suicide Mortality Rates between 1997–1998 and 2000–2001 in Nantou County of Taiwan Following the Earthquake of September 21 in 1999

Abstract:  The paper aims to show the different suicide mortality rate between 1997–1998 and 2000–2001 in Nantou County of Taiwan with earthquake on September 21 (often referred to as the "9-21 earthquake") in 1999. In additional, it also identifies the preventive strategies for the high-risk suicide population. The age-standardized mortality rates for suicide in Nantou County were calculated for the years 1997–1998 and 2000–2001. The suicide standardized mortality ratio (SMR for townships in Nantou were calculated by "type of township" as the standard rate). There is a statistically significant difference in male suicide rates for the years prior to the earthquake (1997–1998) when pooled and compared to the suicide rates for the years after the earthquake (2000–2001). The rate for four age groups (under 25, 25–44, 45–64, 65 and above) all increased, yet all but one (the group of age 45–64) was not statistically significant. The male SMR has slightly increased after the 9-21 earthquake. Yet there are no statistical significances in most townships, except in Kaohsiung and Puli after the 9-21 earthquake. The Kaohsiung SMRs were 1.36 (95% CI: 0.54–2.80) before the earthquake (1997–1998) and 2.01 (95% CI: 1.04–3.52) after the earthquake (2000–2001). The SMRs before and after the earthquake in the Puli Township were 1.51 (95% CI: 0.95–2.29) to 1.56 (95% CI: 1.03–2.27). This study suggests that monitoring high-risk population, especially males or 45–64 years of age who experienced the highest statistically significant suicide rate in this study. The study provides support for providing both the psychological restoration program and, to the extent feasible, financial support for the unemployed as useful public health strategies for suicide prevention in Taiwan.     

International Conference on Harmonisation; revised guidance on Q3B(R) Impurities in New Drug Products; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q3B(R) Impurities in New Drug Products.' The revised guidance, which updates a guidance on the same topic published in the Federal Register of May 19, 1997 (the 1997 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The revised guidance is intended to provide guidance to applicants for drug marketing registration on the content and qualification of impurities in new drug products produced by chemically synthesized new drug substances not previously registered in a country, region, or member State. The revised guidance clarifies the 1997 guidance, adds information, and provides consistency with more recently published ICH guidances. The revised guidance complements the ICH guidance entitled "Q3A(R) Impurities in New Drug Substances.'     

International Conference on Harmonisation; guidance on E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations to sponsors concerning clinical studies to assess the potential of a new drug to cause cardiac arrhythmias, focusing on the assessment of changes in the QT/QTc interval on the electrocardiogram as a predictor of risk. The guidance is intended to encourage the assessment of drug effects on the QT/QTc interval as a standard part of drug development and to encourage the early discussion of this assessment with FDA.     

International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first is a guidance entitled "Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV' (the Q1F guidance). The second is a revised guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products' (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations.     

Drunk drivers—Chances for and difficulties in giving medico-legal opinions on drivers’ alcohol intoxication levels, on the basis of the material analyzed in the Forensic Medicine Department, Medical University of Silesia, Katowice in the years 2003–2007

The authors have conducted a statistical analysis of 340 court files investigated in the Forensic Medicine Department Medical University of Silesia, Katowice in the years 2003–2007 with regard to chances for as well as difficulties in giving medico-legal opinions on drivers’ alcohol intoxication levels, which would be valid for court purposes.     

International Conference on Harmonisation; guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The purpose of the guidance is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. The guidance is intended to assist in the collection of relevant technical information that serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety, and efficacy of the drug product.