Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications.

Stress testing (also known as forced degradation) of pharmaceutical drug substances and products is a critical part of the drug development process, providing insight into the degradation pathways of drug substances and drug products. This information is used to support the development of stability-indicating methods (SIMs) capable of detecting pharmaceutically relevant degradation products that might potentially be observed during manufacturing, long-term storage, distribution, and use. Assessing mass balance of stressed samples is a key aspect of developing SIMs and is a regulatory expectation.

Pharmaceutical Forced Degradation (Stress Testing) Endpoints: A Scientific Rationale and Industry Perspective.

Forced degradation (i.e., stress testing) of small molecule drug substances and products is a critical part of the drug development process, providing insight into the intrinsic stability of a drug that is foundational to the development and validation of stability-indicating analytical methods.

Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study.

Stress testing (also known as forced degradation) of pharmaceutical products has long been recognized as a critical part of the drug development process, providing foundational information related to intrinsic stability characteristics and to the development of stability-indicating analytical methods. A benchmarking study was undertaken by nine pharmaceutical companies and the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, or ANVISA) with a goal of understanding the utility of various stress testing conditions for producing pharmaceutically-relevant chemical degradation of drugs. Special consideration was given to determining whether solution phase stress testing of solid drug products produced degradation products that were both unique when compared to other stress conditions and relevant to the formal drug product stability data.

The impact of California's full-service partnership program on mental health-related emergency department visits.

Objective: This study examined the effects of California's 2005 Mental Health Services Act (MHSA) on the use of mental health-related emergency department visits. It focused on one MHSA program, the full-service partnership program, and hypothesized that individuals with public insurance who participate in the higher-quality full-service partnership program would have fewer emergency department visits compared with clients with public insurance who receive usual care.

Methods: Data were obtained from the Short-Doyle/Medi-Cal (Medicaid) file, the Data Collection and Reporting system, and the Consumer and Service Information System, all maintained by the California Department of Mental Health.

Recovery in the USA: from politics to peer support.

Efforts to transform the mental health service delivery system to a more consumer-driven and recovery-orientated approach has its roots in a somewhat radical anti-psychiatry and civil-rights movement dating back to the 1970s. This grass-roots effort gained momentum and credibility with Harding's landmark study published in 1988 followed by the work of Anthony et al. from Boston University in beginning to define the term 'recovery'.

The mitochondrial permeability transition pore regulates nitric oxide-mediated apoptosis of neurons induced by target deprivation.

Ablation of mouse occipital cortex induces precisely timed and uniform p53-modulated and Bax-dependent apoptosis of thalamocortical projection neurons in the dorsal lateral geniculate nucleus (LGN) by 7 d after lesion. We tested the hypothesis that this neuronal apoptosis is initiated by oxidative stress and the mitochondrial permeability transition pore (mPTP). Preapoptotic LGN neurons accumulate mitochondria, Zn(2+) and Ca(2+), and generate higher levels of reactive oxygen species (ROS), including superoxide, nitric oxide (NO), and peroxynitrite, than LGN neurons with an intact cortical target.

Involuntary civil commitments after the implementation of California's Mental Health Services Act.

Objective: As of fiscal year 2008-2009, California's Mental Health Services Act (MHSA) has distributed $3.2 billion in new tax revenues to county mental health systems. This voter-approved act attempts to address the needs of unserved and underserved consumers with severe mental illness by implementing a "whatever it takes" approach.

What predicts recovery orientation in county departments of mental health? A pilot study.

In this pilot study we examined the determinants of recovery orientation among employees and influential stakeholders in a sample of 12 county departments of mental health in California. A two-level hierarchical linear model with random intercepts was estimated. Analyses show that recovery orientation has a U-shaped relationship with the age of staff/influential stakeholders and is negatively related to the difference between the desired level of adhocracy and the current level of adhocracy.

Scales to evaluate quality of medication management: development and psychometric properties.

This paper describes the psychometric properties of two fidelity scales created as part of the Substance Abuse and Mental Health Services Administration (SAMHSA) sponsored medication management toolkit and their metric properties when used in 26 public mental health clinics with 50 prescribers. A 23-item scale, based on chart reviews, was developed to assess whether prescribers are following good medication practices, in conjunction with a 17-item scale to assess organizational support for and evaluation of prescriber adherence to recommended medication-related practices. Fundamental gaps in routine practice, including poor documentation of medication history and infrequent monitoring of symptoms and side effects were found.

Transformation of the California mental health system: stakeholder-driven planning as a transformational activity.

Objective: This study describes strategies developed by California counties to transform their mental health systems under the 2004 Mental Health Services Act (MHSA). This voter initiative places a 1% tax on annual incomes over $1 million; tax monies are earmarked to transform county-operated mental health services into systems that are oriented more toward recovery. MHSA implementation itself can be considered "transformational" by balancing greater standardization of mental health service delivery in the state with a locally driven planning process.

Safety of intravitreal ketorolac and diclofenac: an electroretinographic and histopathologic study.

Objective: To determine the clinical, histologic, and electroretinographic effects in the rabbit retina of escalating doses of two intravitreally delivered nonsteroidal anti-inflammatory drugs (NSAIDs): ketorolac and diclofenac.

Methods: Right eyes received a single 0.1 mL injection of either ketorolac (500-6000 microg/0.

Report of recommendations: the Annapolis Coalition Conference on Behavioral Health Work Force Competencies.

In May 2004, the Annapolis Coalition on Behavioral Health Workforce Education convened a national meeting on the identification and assessment of competencies. The Conference on Behavioral Health Workforce Competencies brought leading consumer and family advocates together with other experts on competencies from diverse disciplines and specialties in the fields of both mental health care and substance use disorders treatment. Aided by experts on competency development in business and medicine, conference participants have generated 10 consensus recommendations to guide the future development of workforce competencies in behavioral health.

Millionaires and mental health: Proposition 63 in California.

In November 2004 California passed Proposition 63, a landmark piece of mental health and fiscal legislation. This initiative places a 1 percent tax on adjusted gross income over dollar 1 million, affecting about 30,000 taxpayers and raising dollar 1.8 billion (a 31 percent increase) in new revenues over the first three years to support county-operated mental health systems.

Sometimes a great notion ... a common agenda for change.

In the midst of a sea of change in the behavioral health care field, there is emerging a common agenda regarding critical issues and challenges. This article briefly examines the implications for education and training as we pursue this common agenda. Understanding the process of social change helps to chart a course for addressing the identified challenges.