39 research outputs found

    Is There a Role for Adversariality in Teaching Critical Thinking?

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    Although there has been considerable recent debate on the topic of adversariality in argumentation, this debate has rarely found its way into work on critical thinking theory and instruction. This paper focuses on the implications of the adversariality debate for teaching critical thinking. Is there a role for adversarial argumentation in critical thinking instruction? Is there a way to incorporate the benefits of adversarial argumentation while mitigating the problems

    Innovating a Writing Group for Female Cancer Patients: A Counselling Field Description

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    The effects of a cancer diagnosis can be devastating and far-reaching. Expressive-supportive group therapy has proven useful for treating patients struggling with many of these effects. In addition, individual therapeutic writing methods have shown benefit for many individuals addressing a variety of difficult life circumstances including cancer. In this article, we describe specific techniques and processes of an innovative expressive journaling group for cancer patients offered at a comprehensive cancer centre in western Canada. Further, we discuss existential and constructivist connections to our clients' experiences and our work. In addition, we note specific practice considerations and references. Finally, implications for research into journal writing groups are provided.Un diagnostic de cancer peut avoir des conséquences dévastatrices et d'une grande portée. Une thérapie de groupe par l'expression et par soutien s'est révélée efficace pour traiter les patientes devant faire face à plusieurs de ces conséquences. De plus, des méthodes individuelles d'écriture thérapeutique se sont révélées utiles pour de nombreuses personnes affrontant des circonstances de vie difficiles, y compris le cancer. Dans cet article, nous décrivons les techniques et les processus particuliers employés par un groupe novateur d'expression par l'écriture, destiné aux patientes atteintes de cancer et offert à un centre de soins anticancéreux intégrés de l'Ouest canadien. De plus, nous discutons des rapports existentiels et constructivistes entre nos travaux et les expériences de nos clientes. Nous offrons des considérations d'intérêt aux praticiens et praticiennes, ainsi que des références bibliographiques. Finalement, nous indiquons des implications pour d'éventuelles recherches sur les groupes d'écriture thérapeutique

    Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants

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    Although plant biotechnology has been widely investigated for the production of clinical-grade monoclonal antibodies, no antibody products derived from transgenic plants have yet been approved by pharmaceutical regulators for clinical testing. In the Pharma-Planta project, the HIV-neutralizing human monoclonal antibody 2G12 was expressed in transgenic tobacco (Nicotiana tabacum). The scientific, technical and regulatory demands of good manufacturing practice (GMP) were addressed by comprehensive molecular characterization of the transgene locus, confirmation of genetic and phenotypic stability over several generations of transgenic plants, and by establishing standard operating procedures for the creation of a master seed bank, plant cultivation, harvest, initial processing, downstream processing and purification. The project developed specifications for the plant-derived antibody (P2G12) as an active pharmaceutical ingredient (API) based on (i) the guidelines for the m anufacture of monoclonal antibodies in cell culture systems; (ii) the draft European Medicines Agency Points to Consider document on quality requirements for APIs produced in transgenic plants; and (iii) de novo guidelines developed with European national regulators. From the resulting process, a GMP manufacturing authorization was issued by the competent authority in Germany for transgenic plant-derived monoclonal antibodies for use in a phase I clinical evaluation. Following preclinical evaluation and ethical approval, a clinical trial application was accepted by the UK national pharmaceutical regulator. A first-in-human, double-blind, placebo-controlled, randomized, dose-escalation phase I safety study of a single vaginal administration of P2G12 was carried out in healthy female subjects. The successful completion of the clinical trial marks a significant milestone in the commercial development of plant-derived pharmaceutical proteins
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