Drug information journal : DIJ / Drug Information Association最新文献

{"title":"Quality Standards for Antiretrovirals in Indian Pharmacopoeia\u0000","authors":"K. Vivekanandan, H. Sharma, G. Singh","doi":"10.1177/0092861512450568","DOIUrl":"https://doi.org/10.1177/0092861512450568","url":null,"abstract":"The global antiretroviral market is expanding dramatically with the approval of competent authorities in individual countries. In India, the Central Drugs Standard Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC) are making efforts to approve and set the standards for antiretroviral drugs, respectively. The IPC publishes an official book of standards known as Indian Pharmacopoeia ( IP ) in fulfillment of the requirements of the Drugs and Cosmetics Act of 1940. There are 41 antiretroviral active pharmaceutical ingredients (APIs) and combinations approved by the CDSCO; the sixth edition of IP contains 52 monographs of different APIs and formulations. The monographs of antiretrovirals include descriptions, identifications, impurities, assays, and specific tests. IP plays a significant role in improving the quality of antiretroviral drugs, which in turn promote public health.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"303 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132872358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug Shortages After the Eastern Japan Earthquake: Experiences in a Tertiary Referral Center","authors":"Jinichi Mori, Ken-Ichi Hasui, T. Tanimoto, T. Matsumura, M. Kami","doi":"10.1177/0092861512448569","DOIUrl":"https://doi.org/10.1177/0092861512448569","url":null,"abstract":"The large earthquake in eastern Japan on March 11, 2011, caused a nationwide drug shortage. The authors investigated the reasons behind the drug shortage and its impacts on clinical practice in a tertiary referral center. From the day the earthquake occurred until September 11, the authors identified shortages of 26 items (2.6% of all drugs in their hospital). The primary shortage causes included the destruction of pharmaceutical plants (n = 24) and packaging factories (n = 1) and a production shift toward other items (n = 1). The nuclear accident at the Fukushima Daiichi nuclear power plant was associated with shortages of 2 items. During the 6-month study period, drug supply of 6 items recovered, alternatives were introduced for 2 items, and prescriptions were restricted for the remaining 3 items. Recoveries were achieved through the repair of damaged factories (n = 18), importation from foreign countries (n = 2), and production in alternate existing factories (n = 1). Physicians avoided long-term prescriptions of all 11 items, and substituted 4 items with similar brand agents, with the informed consent of patients. Although large-scale disasters inevitably cause drug shortages across broad areas even in developed countries, these shortages can be minimized by the coordinated efforts of clinicians and patients.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126576904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effective Approach to Managing Laboratory Reference Ranges for Local Laboratories in Clinical Research","authors":"V. Tantsyura, Imogene Grimes, J. Mitchel, Sergiy Sirichenko, Jim Crowe, D. Viola","doi":"10.1177/0092861512446333","DOIUrl":"https://doi.org/10.1177/0092861512446333","url":null,"abstract":"The use of a single central laboratory with universal references ranges is not always a viable option in clinical studies; examples are oncology studies where a rapid turnaround of clinical laboratory results is critical. However, the complexities associated with multiple sites, multiple laboratories, and multiple age and sex groups can lead to logistical nightmares across clinical trials and make handling laboratory data one of the most challenging, labor-intensive, and time-consuming tasks for clinical data managers, especially where different laboratories are used for the same patient. Also, evidence suggests that the reference ranges (RRs) used by the local laboratories often create a false sense of precision that is not always supported by science. Managing time-specific, demographic-specific, and site-specific RRs requires significant investment in time and labor. As a result, an alternative approach to management of local laboratory RRs that uses “standard” (sometimes called “published”) ranges has been growing in popularity over the past several years. This article attempts to compare the pros and cons of this approach relative to the historic ways of handling local laboratory RRs. Scientific, operational, and economic perspectives are also presented.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122787354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Designing Phase 2 Trials Based on Program-Level Considerations: A Case Study for Neuropathic Pain","authors":"Nitin R. Patel, J. Bolognese, C. Chuang-Stein, D. Hewitt, A. Gammaitoni, J. Pinheiro","doi":"10.1177/0092861512444031","DOIUrl":"https://doi.org/10.1177/0092861512444031","url":null,"abstract":"Traditionally, sample size considerations for phase 2 trials are based on the desired properties of the design and response information from the trials. In this article, we propose to design phase 2 trials based on program-level optimization. We present a framework to evaluate the impact that several phase 2 design features have on the probability of phase 3 success and the expected net present value of the product. These factors include the phase 2 sample size, decision rules to select a dose for phase 3 trials, and the sample size for phase 3 trials. Using neuropathic pain as an example, we use simulations to illustrate the framework and show the benefit of including these factors in the overall decision process.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114347304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Some Thoughts on Challenges for Noninferiority Study Designs","authors":"D. DeMets, L. Friedman","doi":"10.1177/0092861512445310","DOIUrl":"https://doi.org/10.1177/0092861512445310","url":null,"abstract":"New interventions that may have some advantage over standard treatments by being less invasive, less toxic, or less costly are often compared to standard therapy. Noninferiority trials aim to demonstrate that the new intervention is almost as good as, or even better than, the standard. A commonly used paradigm makes numerous assumptions to obtain a statistical and clinical margin of noninferiority, many of which are difficult to prove and may be based on subjective assessments. We discuss these assumptions and give examples where they are not met. Regardless of the methods that are used, the margin of noninferiority must reflect what patients and health care providers are willing to balance for the possible benefits of the new intervention for fewer adverse events or less invasiveness or cost.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"406 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116667836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality Aspects of Oligonucleotide Drug Development: Specifications for Active Pharmaceutical Ingredients","authors":"D. Capaldi, K. Ackley, D. Brooks, J. Carmody, K. Draper, R. Kambhampati, M. Kretschmer, Daren S Levin, J. Mcardle, B. Noll, R. Raghavachari, I. Roymoulik, B. P. Sharma, René Thürmer, F. Wincott","doi":"10.1177/0092861512445311","DOIUrl":"https://doi.org/10.1177/0092861512445311","url":null,"abstract":"This article, which is the first in a planned series intended to address chemistry, manufacturing, and control (CMC) aspects of therapeutic oligonucleotides, examines the topic of specifications for active pharmaceutical ingredients (APIs). The authors attempt to present basic scientific considerations for the broadest range of oligonucleotide APIs. Tests and analytical methods suitable for the control of single- and double-stranded oligonucleotide APIs and conjugated oligonucleotide APIs are discussed.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"60 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121684951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FDA’s Flexibility in the Approval of Orphan Drugs","authors":"Anne R. Pariser, Larry Bauer","doi":"10.1177/0092861512447188","DOIUrl":"https://doi.org/10.1177/0092861512447188","url":null,"abstract":"We wish to thank Mr Sasinowski for his comprehensive review of orphan drug approvals within the US noncancer setting. We greatly appreciate his documentation of the regulatory flexibility and scientific judgment that FDA has exercised in the service of patients with rare diseases. The agency similarly recognizes the important contributions that the rare disease community has made to our shared mission in public health, and the timely review and approval of orphan drugs has been an FDA priority. Of the 30 new molecular entities that the agency shepherded through review and approval last year, more than one-third were indicated for rare diseases. We have recently completed our own analysis of orphan drug approvals issued for oncologic as well as nononcologic indications between 2006 and February 2012, by the FDA Center for Drug Evaluation and Research. The results of our analysis speak to the FDA product review programs that Mr Sasinowski frames in terms of regulatory flexibility. In this time period, there were 104 orphan drug approvals, approximately two-thirds of which relied on approval programs that allow for deviation from the traditional standard criterion for clinical evidence based on 2 or more adequate and well-controlled trials. In agreement with Mr Sasinowski’s analysis, we concur that individual orphan drug development programs are often unique, with their own particular biomedical exigencies, and we have accordingly seen considerable diversity among the clinical trial designs that were used to support the orphan drug approvals that we examined (2006–2012). Trial design as manifested in these approvals is highly dependent on the characteristics of the disease, drug, and population under study. Other factors have also contributed to the regulatory flexibility that we have seen in orphan drug development. For example, we believe that an especially important basis for achievements in orphan drug development was the establishment of close and thoughtful communication between regulatory agencies and drug developers. The timely review and approval of orphan drugs remains an FDA priority. From our own assessment of drug approvals for rare diseases, we would stress the importance of the collaborative dimensions of the process, involving FDA staff, trial investigators and sponsors, as well patients and members of the rare disease community. We urge orphan drug developers to work closely with the FDA throughout drug development—especially early on in the process—so that clinical evidence can be efficiently and appropriately assessed in terms of US statutory standards for approval. The sharing of information and perspectives among the various stakeholders of drug development has clearly increased in recent years and will likely remain crucial, not only for the approval of new drugs to treat rare diseases but also to meet needs that are more broadly emerging in the current health care setting.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129865557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of Targeted Agents and Companion Diagnostics","authors":"Béatrice Gerard, Marie-Christine Bétard, Bradley L. Smith, M. Denyer","doi":"10.1177/0092861512444032","DOIUrl":"https://doi.org/10.1177/0092861512444032","url":null,"abstract":"This article summarizes a presentation made at the joint BIA/MHRA conference, “Challenges of Development of Targeted Agents and Companion Diagnostics,” in London in March 2011. It focuses on the challenges the pharmaceutical industry is facing with the development of targeted agents in the field of oncology, in parallel with the challenges associated with the identification and development of the necessary diagnostic tools to support patient selection for personalized therapy. This article will encompass clinical, technical, and regulatory aspects.","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115352266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum to: Review of Translational Medicine and Drug Discovery\u0000","authors":"E. Tabor","doi":"10.1177/0092861512446792","DOIUrl":"https://doi.org/10.1177/0092861512446792","url":null,"abstract":"In this book review published in the March 2012 issue, the reviewer should be shown as: Edward Tabor, MD, Quintiles, Rockville, Maryland, USA","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129639066","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum to: Editor’s Commentary, March 2012 Issue","authors":"J. R. Turner","doi":"10.1177/0092861512446793","DOIUrl":"https://doi.org/10.1177/0092861512446793","url":null,"abstract":"In the Editor’s Commentary for the March 2012 issue, the bold text in the sentence below (from page 156, left column) is incorrect:","PeriodicalId":391574,"journal":{"name":"Drug information journal : DIJ / Drug Information Association","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2012-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123077660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}