A Proposal for an Alternative Approach to Particle Size Method Development During Early-Stage Small Molecule Pharmaceutical Development

Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation conforms to the true value. Defining a “true” value for the size of a particle can be challenging as the output of its measurement will differ because of variations in measurement approaches, instrumental differences and calculation methods. Consequently, for “real” particles, a universal “true” value does not exist and accuracy is therefore not a definable characteristic. Accordingly, precision is then a measure of the ability to reproducibly achieve a measurement of unknown relevance.This article proposes, in place of accuracy, a means to define the “appropriateness” of a measurement in line with the critical quality attributes (CQA) of the material being characterized. The decision as to whether the measurement is correct should involve a link to the CQA; that is, correlation should be demonstrated, without which the measured particle size cannot be defined as a critical material attribute.Correspondingly, methods should also be able to provide sufficient precision to demonstrate discrimination relating to variation in the CQA. The benefits and challenges of this approach are discussed.     

The history of ideas of Nordic midwives’ excursions from the early 19th century to the millennium

The midwifery art has emphasised the uniqueness of human beings throughout its Nordic history. The educated Nordic midwife has in the last decade celebrated several hundred years of memories. This article studies how the key ideas of the midwifery art and patterns of ideas become evident in the zeitgeist from the beginning of the 19th century to the millennium in the Nordic countries. The legacy and pattern of ideas of the art of midwifery are interpreted in relation to the texts of the selected historical sources and based on Ricoeur's phenomenological-hermeneutic approach to the text and further to the dedication of understanding and interpretation. The historical sources refer to unprinted primary sources from historical archives and printed secondary and tertiary sources. The patterns of ideas include a tripartite whole: the true cultivation of the head, the philosophy and aesthetics of the hand, the strength of the heart and the drive of calling. These ideas open for unique visions and attest to the evident in modern midwives. Today's midwives have academic training with examinations, and the education is based on scientific evidence. The midwife profession is authorised by the state and supervised by the authorities.     

Subjective leisure experiences of older Australians

Background:  Previous studies into leisure have employed methodologies that may understate the significance of experiential components. This exploratory study investigated the leisure experiences of retired Australians over 65 years of age.
Methods:  Five semistructured interviews were used to explore the leisure experience of older people from metropolitan Adelaide. Data were coded and analysed thematically.
Results:  Relaxation and engrossment emerged as commonly expressed experiences, yet were found to emerge as a result of engagement in occupations predefined as leisure. Experiences of freedom from both necessary duties and a sense of obligation were discussed as potential determinants of leisure consciousness.
Practice implications:  This study highlights a need for therapists to actively access clients' subjective leisure experiences to enable engagement in personally meaningful leisure occupations.     

Reflections and Perspectives on Pediatric Psychology: Editor's Vale Dictum

Reviews major activities of the Editor and changes in the Journalof Pediatric Psychology (JPP) for issues published in 1993 through1997. Significant trends and accomplishments are reviewed, includingthe increased use of Special Issues and Special Sections tohighlight current pediatric psychological research. Articlespublished during the term are analyzed interms of article typeand population type Comarisons are made to earlier trends inJPP publication as reported by Roberts (1 992).