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81.
Fontaine RG 《Clinical psychology review》2007,27(5):655-675
This paper reviews and organizes relevant theory and research toward a conceptual framework of instrumental antisocial decision-making and behavior in youth. To date, social cognitive study of the development of youth antisocial functioning has largely focused on response patterns (e.g., cognitive responses to aversive cues). Though instrumental decision making is paid significant attention in research on adult criminality, there exists no framework by which youths' goal-driven behavioral decisions that are made in pursuit of antisocial motives and interests may be understood. This is a problem in that lessons from research on children and adolescents suggest that there are meaningful differences in structure, phenomenology and function of subtypes of antisocial behavior (instrumental versus reactive). The absence of such a model may account, at least in part, for why the study of instrumental antisocial behavior in youth remains relatively limited. 相似文献
82.
Griffith J Gantz S Lowry J Dai H Bada H 《Journal of the National Medical Association》2007,99(9):1037-1041
OBJECTIVES: To compare third-party payor reimbursement for patients evaluated in a university-based pediatric weight management clinic in central Kentucky. STUDY DESIGN: Demographic and reimbursement data were reviewed for 120 patients evaluated January to December 2004. Statistical analysis included Kruskal-Wallis test and Friedman's test. RESULTS: Overall, median reimbursement was 60%. For new appointments, contracted (56%) and capitated (60%) reimbursements were higher than Medicaid (55%). For established appointments, Medicaid reimbursement (100%) was higher than contracted (37%) and capitated (58%). CONCLUSION: Our data suggest that reimbursement is influenced by regional factors and is improving in central Kentucky. 相似文献
83.
Griffith J Caron CD Desrosiers J Thibeault R 《Canadian journal of occupational therapy. Revue canadienne d'ergothérapie》2007,74(2):78-90
BACKGROUND: In the Canadian Model of Occupational Performance, meaningful occupation involves interaction between spirituality and environment. However little research exists on the process of giving meaning to occupation. PURPOSE: This study explored both meaningful occupation and the definition of spirituality from the perspective of community-dwelling older adults with autonomy loss. METHOD: Using a qualitative approach, grounded theory method of Glaser and Strauss (1967), eight cognitively intact persons were interviewed individually. RESULTS: The process of giving meaning to occupation involves an intrinsic link between identity and meaningful occupation, with identity being central to the person. Following autonomy loss, a process of adjusting identity, involving social, psychological and spiritual aspects, occurs over time. Spirituality is defined in terms of its close links to religion and belief in a benevolent greater power. IMPLICATIONS OF RESEARCH: This study contributes to the discussion of the concepts of spirituality, identity and meaning in occupational therapy. 相似文献
84.
85.
Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions’ information technology systems.Key Words: biologics, biosimilars, formulary, pharmacovigilance, reference productThe first biosimilar was licensed for use in humans in the European Union (EU) in 2006; since that time, a total of 11 distinct biosimilar products have been approved for marketing in the EU under 19 different trade names (2 have since been withdrawn) (1 As more patents for biologic drugs approach expiration, the number of biosimilars entering the market is expected to grow.2,3 Yet, as the market awaits the first US biosimilar approval, questions remain about how this new class of drugs will be evaluated for incorporation into US formularies. In the US, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)—a part of the Affordable Care Act of 2009—provided for an abbreviated regulatory approval pathway for biosimilars.4,5 As defined by the BPCI Act, a biosimilar is a biologic product that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components; a biosimilar is to have no clinically meaningful differences from its reference product in terms of safety, purity, and potency. 4
Open in a separate windowaAs of September 3, 2014.bThe same biosimilar from one manufacturer (eg, Sicor Biotech UAB) may be marketed under different brand names.cMarketing authorization in the EU withdrawn at the request of the marketing authorization holder.Small-molecule generic drugs can be produced using well-defined chemical processes, but biologic drugs are typically large molecules with a complex structure that are manufactured in bioreactors using living cells.6 Because the details of manufacturing processes for biologic drugs are often proprietary to the innovator manufacturer, the processes for biosimilar production, such as cell culture, fermentation, and purification, must be independently developed by the biosimilar manufacturer.6 Consequently, there is potential for subtle differences between biosimilars and their reference products.6–8 Thus, biosimilars will require more extensive evaluation than small molecule generic drugs9; the type and amount of clinical data required will be determined on a case-bycase basis.10The US Food and Drug Administration (FDA) approval pathway for biosimilars recommends a side-by-side comparison with an approved reference product that should include comparative analytic studies to characterize the product and to identify impurities, animal studies to assess toxicity, clinical studies to assess pharmacokinetics and/or pharmacodynamics and immunogenicity, and additional studies as needed to demonstrate safety and efficacy in the intended conditions of use.10,11 Because this abbreviated approval pathway is based on demonstrated similarity to a well characterized, approved reference product, it is expected that some biosimilars will be approved with fewer patients studied and less clinical efficacy and safety data than were required for the reference product, but with more required analytical information (eg, structure and function).12,13 However, based on the US definition of a biosimilar, clinical data are not anticipated to significantly differentiate a biosimilar from its reference product. According to the FDA’s interpretation of the BPCI Act, a biosimilar can be approved with fewer indications of use, fewer routes of administration, fewer product presentations, and different formulations and container closures than the reference product.14 Although no clinically relevant differences in safety or efficacy between a biosimilar and its reference products are permitted, there could be some differences in immunogenicity profiles that are not considered clinically relevant; in some cases, these differences may only become apparent through postapproval safety monitoring.10 Therefore, it is important for pharmacists to consider additional product- and manufacturer-related parameters when evaluating biosimilars for potential formulary inclusion.9Given the unique nature of biosimilars and their abbreviated regulatory pathway, formulary review and therapeutic interchange options will need to be considered for this class of medicines. This review provides an overview of biosimilars, offers insights into EU and US regulatory pathways for biosimilars, and recommends a checklist of considerations for pharmacists when evaluating biosimilars for inclusion in a US health-system formulary. 相似文献
Table 1.
Biosimilars authorized in the European UnionaBiosimilar | Active substance | Manufacturerb | Marketing authorization holder/applicant |
Granulocyte colony-stimulating factors | |||
Biograstim | filgrastim | Sicor Biotech UAB | CT Arzneimittel GmbH |
Filgrastim Hexal | filgrastim | Sandoz GmbH | Hexal AG |
Filgrastim ratiopharmc | filgrastim | Sicor Biotech UAB | Ratiopharm GmbH |
Grastofil | filgrastim | Intas Biopharmaceuticals Ltd.; Apotex Nederland BV | Apotex Europe BV |
Nivestim | filgrastim | Hospira Zagreb | Hospira UK Ltd. |
Ratiograstim | filgrastim | Sicor Biotech UAB | Ratiopharm GmbH |
Tevagrastim | filgrastim | Sicor Biotech UAB | Teva Generics GmbH |
Zarzio | filgrastim | Sandoz GmbH | Sandoz GmbH |
Erythropoietins | |||
Abseamed | epoetin alfa | Rentschler Biotechnologie GmbH; Lek Pharmaceuticals | Medice Arzneimittel Pütter GmbH & Co. KG |
Binocrit | epoetin alfa | Rentschler Biotechnologie GmbH; Lek Pharmaceuticals | Sandoz GmbH |
Epoetin Alfa Hexal | epoetin alfa | Rentschler Biotechnologie GmbH; Lek Pharmaceuticals | Hexal AG |
Retacrit | epoetin zeta | Norbitec GmbH | Hospira UK Ltd. |
Silapo | epoetin zeta | Norbitec GmbH | Stada Arzneimittel AG |
Growth hormones | |||
Omnitrope | somatropin | Sandoz GmbH | Sandoz GmbH |
Valtropinc | somatropin | LG Life Sciences Ltd. | BioPartners GmbH |
Follicle-stimulating hormone | |||
Bemfola | follitropin alfa | Polymun Scientific Immunbiologische Forshung GmbH; Finox Biotech AG | Finox Biotech AG |
Ovaleap | follitropin alfa | Merckle Biotec GmbH; Teva Pharmaceuticals; Europe BV | Teva Pharma BV |
Anti-human tumor necrosis factor alpha 2 monoclonal antibody | |||
Inflectra | infliximab | Celltrion Inc. | Hospira UK Ltd |
Remsima | infliximab | Celltrion Inc. | Celltrion Healthcare Hungary Kft |
86.
87.
O W Griffith A Meister 《Proceedings of the National Academy of Sciences of the United States of America》1977,74(8):3330-3334
Substrate analogs have been obtained that selectively inhibit the reactions of the gamma-glutamyl cycle or that are susceptible to only limited metabolism by the cycle. Thus, glutathione synthesis may be inhibited and analogs of glutathione may be synthesized that do not participate in transpeptidation. Specific inhibitors of gamma-glutamylcyclotransferase and 5-oxoprolinase have been obtained. The findings offer new approaches to the in vivo study of the cycle and also to the design of more specifically directed analogs of inhibitors such as methionine sulfoximine and 6-diazo-5-oxonorleucine. 相似文献
88.
89.
Lubaroff David M. Vaena Daniel Brown James A. Zehr Pamela Griffith Karen C. Brown Erica Eastman Julie Nepple Kenneth Kattula Ambika Williams Richard D. 《Immunologic research》2014,59(1-3):229-235
Immunologic Research - Preclinical studies demonstrated the ability of an adenovirus/PSA (Ad/PSA) vaccine to induce strong anti-PSA immune responses, and these responses were capable of destroying... 相似文献
90.
Mejía Anilena Bertello Lucía Gil Johany Griffith Jaravis López Ana Isabel Moreno Milena Calam Rachel 《International journal of mental health and addiction》2020,18(2):482-499
International Journal of Mental Health and Addiction - Family skills training programs (FSTPs) are the interventions of choice for the prevention of alcohol and drug use worldwide. However, the... 相似文献