Promoting GMP implementation: developing training materials for the international audience.

This paper outlines the development of a CD-ROM training package entitled: The WHO Basic Training Modules on GMP, intended to support the creation of training courses aimed particularly at government compliance officials who inspect pharmaceutical manufacturing facilities. The material was created over a three-year period in collaboration with a team of external experts, WHO regional and local offices, and Drug Regulatory Authorities of participating countries. The nine training workshops and courses that contributed to the development and evaluation processes were attended by approximately 240 participants from 47 countries.

Six rapid tests for direct detection of Clostridium difficile and its toxins in fecal samples compared with the fibroblast cytotoxicity assay.

Clostridium difficile is one of the most frequent causes of nosocomial gastrointestinal disease. Risk factors include prior antibiotic therapy, bowel surgery, and the immunocompromised state. Direct fecal analysis for C.

Improved insulin sensitivity and body fat distribution in HIV-infected patients treated with rosiglitazone: a pilot study.

The insulin-sensitizing drugs thiazolidinediones (TZDs), such as rosiglitazone, improve insulin sensitivity and also promote adipocyte differentiation in vitro. The authors hypothesized that TZDs might be beneficial to patients with HIV disease to improve insulin sensitivity and the distribution of body fat by increasing peripheral fat. The ability of rosiglitazone (8 mg/d) to improve insulin sensitivity (from hyperinsulinemic-euglycemic clamp) and to improve body fat distribution (determined from computed tomography measurements of visceral adipose tissue [VAT] and subcutaneous adipose tissue [SAT]) was determined in 8 HIV-positive patients.

The outer membrane localization of the Neisseria gonorrhoeae MsrA/B is involved in survival against reactive oxygen species.

The PilB protein of Neisseria gonorrhoeae has been reported to be involved in the regulation of pilin gene transcription, but it also possesses significant homology to the peptide methionine sulfoxide reductase family of enzymes, specifically MsrA and MsrB from Escherichia coli. MsrA and MsrB in E. coli are able to reduce methionine sulfoxide residues in proteins to methionines.

Ritonavir: an extraordinary example of conformational polymorphism.

Purpose: In the summer of 1998, Norvir semi-solid capsules supplies were threatened as a result of a new much less soluble crystal form of ritonavir. This report provides characterization of the two polymorphs and the structures and hydrogen bonding network for each form.

Methods: Ritonavir polymorphism was investigated using solid state spectroscopy and microscopy techniques including solid state NMR, Near Infrared Spectroscopy, powder X-ray Diffraction and Single crystal X-ray.

The use of near-infrared spectroscopy to monitor the mobility of water within the sarafloxacin crystal lattice.

Near-infrared spectroscopy (NIRS) is proposed as a technique to study the mobility of water within the sarafloxacin crystal lattice. An investigation of two samples of sarafloxacin revealed that NIRS can distinguish between acceptable and unacceptable batches for formulation purposes. X-ray powder diffraction (XRPD), mid-infrared (mid-IR) spectroscopy, differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) could not detect any differences between the two samples.

Role of an isomorphic desolvate in dissolution failures of an erythromycin tablet formulation.

The investigation of dissolution failures for erythromycin dihydrate tablet formulation over a 12-month period using a near-infrared spectroscopy technique revealed the role of a desolvated dihydrate in the retardation of dissolution. Near infrared spectroscopy (NIR) indicated a dehydrated dihydrate of erythromycin is produced during formulation and gradually binds with Mg(OH)2. The binding delays the process of dissolution.

Occupational health psychology: historical roots and future directions.

Occupational health psychology (OHP) is a term first coined by Jonathan Raymond in 1990, yet OHP has historical, international roots dating at least to the early decades of the twentieth century. It involves research and practice to create healthy workplaces. This article has 4 sections.

Introduction to the measurement of stress at work.

This article introduces a special section on the measurement of stress in occupational and work environments. It discusses stress as a creatively ambiguous term that, nonetheless, has important medical, behavioral, and psychological health consequences for people at work as well as away from work. The article discusses the importance of multiple medical and psychological measures for occupational stress assessments and offers an abbreviated conceptual framework for such measures.

Partnerships for health in the 21st century.

This paper presents the results of a working group on partnerships in preparation for the WHO Health for All Policy for the 21st Century. The working group aimed to clarify the nature of partnerships for health, proposed six categories of partnerships and outlined principles and criteria for partnerships. It concluded that partnership building was a key strategic component of health development and underlined that WHO must increasingly see its role as one of mustering support for health from many players.

Sexual harassment at work. Introduction.

This article introduces the special section on sexual harassment at work. It discusses the importance of sexual harassment as a continuing, chronic occupational health psychology problem to which the public health and preventive medicine notions of prevention may be applied. The article discusses the dilemmas in conducting and reviewing research on harassment, briefly examining some alternative methods of inquiry.

Evaluation of Resistance of Winter Wheat to Fusarium acuminatum by Inoculation of Seedling Roots with Single, Germinated Macroconidia.

Fusarium acuminatum is one of the causal agents of dryland root rot of winter wheat in Colorado. The effect of F. acuminatum seedling root infection, recorded at heading, on winter wheat cultivars Sandy and CO84 was investigated in the greenhouse.

Undercover careseekers: simulated clients in the study of health provider behavior in developing countries.

The simulated client method (SCM) has been used for over 20 years to study health care provider behavior in a first-hand way while minimizing observation bias. In developing countries, it has proven useful in the study of physicians, drug retailers, and family planning services. In SCM, research assistants with fictitious case scenarios (or with stable conditions or a genuine interest in the services) visit providers and request their assistance.

Creating healthier workplaces: The American Psychological Association/National Institute of Occupational Safety and Health cooperative agreement. Introduction and historical overview.

This article introduces the special section on the American Psychological Association/National Institute for Occupational Safety and Health (APA/NIOSH) collaboration. The section includes an overview statement of National Institute for Occupational Safety and Health research by Linda Rosenstock and 5 competitively peer-reviewed articles submitted to the Journal of Occupational Health Psychology following their presentation in an earlier form at the 3rd APA/NIOSH conference in September 1995. This article provides a brief history of the APA/NIOSH collaboration forged at the turn of this decade.

Advancing public policy, social science, and biomedical inquiry: state-of-the-art reviews. IV.

In this article, the author introduces the fourth special section of state-of-the-art reviews. He discusses the public policy and epistemological contributions of the 2 articles in this section in terms of the translation of scientific research findings into public policy actions.

Contributing concepts and methods across disciplinary boundaries: state-of-the-art reviews. III.

This article introduces the third special section of state-of-the-art reviews. The conceptual and methodologic contributions of the 3 articles in this section are framed, noting the importance of the public health, preventive medicine, and sociological disciplines represented.