30 results match your criteria Pharmaceutical Medicine[Journal]

  • Page 1 of 1

Adverse Drug Reaction Onsets in Uganda's VigiBase: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses.

Pharmaceut Med 2018 17;32(6):413-427. Epub 2018 Nov 17.

3MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.

Introduction: Developing countries can improve their pharmacovigilance systems by analysing their own medication safety data.

Objective: The aims of this study were to characterize Uganda's reported adverse drug reaction (ADR) onsets in 2012-2015 that were registered on VigiBase by 31 December 2017, to document delays in international visibility and the influence of covariates on this delay from ADR onsets in 2013 + 2014, to examine data quality, and to illustrate analytical approaches for safety data, particularly for patients receiving antiretroviral therapy (ART).

Methods: International delay was defined as elapsed time from complete ADR onset date to entry date on VigiBase, with covariates examined using Cox proportional hazards regression. Read More

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http://dx.doi.org/10.1007/s40290-018-0253-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267548PMC
November 2018
9 Reads

Training Augmented Intelligent Capabilities for Pharmacovigilance: Applying Deep-learning Approaches to Individual Case Safety Report Processing.

Pharmaceut Med 2018 13;32(6):391-401. Epub 2018 Oct 13.

1Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 USA.

Introduction: Regulations are increasing the scope of activities that fall under the remit of drug safety. Currently, individual case safety report (ICSR) collection and collation is done manually, requiring pharmacovigilance professionals to perform many transactional activities before data are available for assessment and aggregated analyses. For a biopharmaceutical company to meet its responsibilities to patients and regulatory bodies regarding the safe use and distribution of its products, improved business processes must be implemented to drive the industry forward in the best interest of patients globally. Read More

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http://dx.doi.org/10.1007/s40290-018-0251-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267537PMC
October 2018
1 Read

Development of New Formulations of Biologics: Expectations, Immunogenicity, and Safety for Subcutaneous Trastuzumab.

Pharmaceut Med 2018 24;32(5):319-325. Epub 2018 Sep 24.

1Breast Disease Division, Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of Sao Paulo, São Paulo, Brazil.

Subcutaneous (SC) trastuzumab has long been approved as a cancer treatment for early and advanced HER2-positive (HER2+) breast cancer by both the European Medicines Agency (EMA) and Agência Nacional de Vigilância Sanitária (ANVISA), the Brazilian National Health Surveillance Agency. A pivotal non-inferiority phase III trial, which aimed to provide a more convenient and cost-effective treatment in the HER2+ breast cancer neoadjuvant setting, showed that the SC group met prespecified efficacy endpoints and the SC formulation was considered as safe as the intravenous (IV) formulation. Considering the recent approval of several biosimilars, new SC formulations are also an interesting manufacturer strategy as these drugs can obtain patent protection. Read More

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http://link.springer.com/10.1007/s40290-018-0247-5
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http://dx.doi.org/10.1007/s40290-018-0247-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182492PMC
September 2018
9 Reads

Excipients in Neonatal Medicinal Products: Never Prescribed, Commonly Administered.

Pharmaceut Med 2018 10;32(4):251-258. Epub 2018 Aug 10.

2Intensive Care and Department of Pediatric Surgery, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.

To attain effective and safe pharmacotherapy, formulations in (pre)term neonates should enable extensive dose flexibility. During product development and subsequent authorization and clinical use of such formulations, there is also a need for informed decisions on excipient exposure: in addition to the need to improve the knowledge on active compounds, there is a similar need to improve the knowledge on excipients in neonates. Excipients are added to formulations as co-solvent, surfactant, preservative, colorant and/or sweetener as vehicle(s) to result in a suitable (e. Read More

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http://dx.doi.org/10.1007/s40290-018-0243-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6105181PMC
August 2018
12 Reads

The European Innovative Medicines Initiative: Progress to Date.

Pharmaceut Med 2018 19;32(4):243-249. Epub 2018 Jul 19.

Research and Innovation, European Commission, 1049 Brussels, Belgium.

The Innovative Medicines Initiative is a public-private partnership between the European Union and the pharmaceuticals industry that was established in 2008, with an overall budget of €5.3 billion from 2008 until 2024. The objective of the initiative is to boost pharmaceutical innovation in Europe and speed up the development of innovative medicines, vaccines and medical technologies, in particular in areas with high unmet needs. Read More

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http://dx.doi.org/10.1007/s40290-018-0241-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6105180PMC
July 2018
9 Reads

Evaluation of Two Strategies for Community-Based Safety Monitoring during Seasonal Malaria Chemoprevention Campaigns in Senegal, Compared with the National Spontaneous Reporting System.

Pharmaceut Med 2018 1;32(3):189-200. Epub 2018 Jun 1.

7Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, WC1E 7HT UK.

Background: Seasonal malaria chemoprevention (SMC) using sulfadoxine-pyrimethamine plus amodiaquine has been introduced in 12 African countries. Additional strategies for safety monitoring are needed to supplement national systems of spontaneous reporting that are known to under represent the incidence of adverse reactions.

Objectives: This study aimed to determine if adverse event (AE) reporting could be improved using a smartphone application provided to village health workers, or by active follow-up using a symptom card provided to caregivers. Read More

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http://dx.doi.org/10.1007/s40290-018-0232-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6006231PMC
June 2018
8 Reads

International Comparison of Five Herbal Medicine Registration Systems to Inform Regulation Development: United Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain.

Pharmaceut Med 2018 20;32(1):39-49. Epub 2018 Jan 20.

Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Stopford Building, Oxford Road, Manchester, M13 9PT UK.

Background: Herbal medicine (HM) regulation is less developed than that of allopathic medicines, with some countries lacking specific regulations.

Objective: For the purpose of informing a registration system for HMs in Kuwait, which does not manufacture but imports all HMs, this study compared the similarities and differences between the current HM registration systems of five countries.

Methods: The five countries were selected as major source countries of HM in Kuwait (United Kingdom (UK), Germany and United States of America (USA)) or because of geographical proximity or size and approach (United Arab Emirates (UAE) and Kingdom of Bahrain). Read More

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http://dx.doi.org/10.1007/s40290-018-0223-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5801395PMC
January 2018
3 Reads

Medicines Regulation in Africa: Current State and Opportunities.

Pharmaceut Med 2017 3;31(6):383-397. Epub 2017 Nov 3.

Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Read More

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http://dx.doi.org/10.1007/s40290-017-0210-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5691122PMC
November 2017
26 Reads

Evaluation of Risk-Minimization Activities for Cyproterone Acetate 2 mg/Ethinylestradiol 35 µg: A Cross-Sectional Physician Survey.

Pharmaceut Med 2017 28;31(5):339-351. Epub 2017 Aug 28.

Pharmacoepidemiology and Risk Management, RTI Health Solutions, 200 Park Offices Drive, Research Triangle Park, 27709 NC USA.

Background: Cyproterone acetate 2 mg/ethinylestradiol 35 µg, an estrogen/progestogen treatment with anti-androgenic properties, shares a thromboembolism risk with combined hormonal contraceptives. Educational materials (i.e. Read More

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http://dx.doi.org/10.1007/s40290-017-0203-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629244PMC
August 2017
25 Reads

Analysis of Safety-Related Regulatory Actions for New Drugs in Japan by Nature of Identified Risks.

Pharmaceut Med 2017 13;31(5):317-327. Epub 2017 Jul 13.

Laboratory of Pharmaceutical Regulatory Science, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033 Japan.

Background: Mechanisms underlying safety events may be heterogeneous and depend on conditions of development and marketing, including the populations studied in clinical trials and the amount of data required for approval, especially under pathways for accelerated access.

Objective: This study was conducted to investigate possible factors affecting the first post-marketing safety-related regulatory actions (SRRAs) after launch of new drugs in Japan.

Methods: We studied 338 new molecular entities (NMEs) approved in Japan between 2004 and 2014. Read More

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http://dx.doi.org/10.1007/s40290-017-0198-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629242PMC
July 2017
13 Reads

Defining biological subsets in systemic lupus erythematosus: progress toward personalized therapy.

Pharmaceut Med 2017 Apr 25;31(2):81-88. Epub 2017 Jan 25.

Mayo Clinic, Division of Rheumatology, Department of Immunology, Rochester, MN, USA.

Systemic lupus erythematosus (SLE) is a heterogeneous disease with respect to disease severity, response to treatment, and organ damage. The pathogenesis of SLE includes immunological mechanisms which are driven by both genetic and environmental factors. There are clear differences in the pathogenesis of SLE between patients of different ancestral backgrounds, including differences in genetic risk factors, immunological parameters, and clinical manifestations. Read More

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http://dx.doi.org/10.1007/s40290-017-0178-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5562038PMC
April 2017
4 Reads

Measuring and Improving Physician Knowledge of Safety Risks Using Traditional and Online Methods in Pharmacovigilance.

Pharmaceut Med 2017 26;31(4):257-266. Epub 2017 Jul 26.

Center for Observational Research, Amgen Inc., Thousand Oaks, CA USA.

Background: Traditional methods for assessing prescriber knowledge can take several years to deliver results. This study was undertaken to obtain insights into the potential for using existing online communities to educate prescribers on therapy-related safety risks.

Objective: The aim of this study was to describe approaches to measuring prescribers' knowledge of safety risk (osteonecrosis of the jaw) outlined in the European Medicine Agency's summary of product characteristics for denosumab (XGEVA). Read More

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http://dx.doi.org/10.1007/s40290-017-0196-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5539261PMC
July 2017
20 Reads

Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events: Implications for Patient Involvement in Regulatory Decisions.

Pharmaceut Med 2017 18;31(4):245-255. Epub 2017 Jul 18.

Department of Pharmacy, Faculty of Health and Medical Sciences, Copenhagen Centre for Regulatory Science, University of Copenhagen, Copenhagen, Denmark.

Background: Increasingly, patients are expected to influence decisions previously reserved for regulatory agencies, pharmaceutical companies, and healthcare professionals. Individual patients have previously represented their patient population when rare, serious adverse events (AEs) were weighed as part of a benefit-risk assessment. However, the degree of heterogeneity of the patient population is critical for how accurately they can be represented by individuals. Read More

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http://dx.doi.org/10.1007/s40290-017-0200-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5539258PMC
July 2017
5 Reads

Different Weights of the Evidence-Based Medicine Triad in Regulatory, Health Technology Assessment, and Clinical Decision Making.

Pharmaceut Med 2017 11;31(4):213-216. Epub 2017 Jul 11.

HealthEcon Ltd, Steinentorstrasse 19, 4051 Basel, Switzerland.

Evidence-based medicine (EBM) is defined as a systematic approach to clinical problem solving by the integration of best research evidence with real-world clinical expertise and patient values. Since those early days, decision requirements expanded from patient-centric clinical decision making to a population-based view including regulatory health technology assessments (HTAs). Regulatory bodies mainly rely on the totality of research evidence, which includes preclinical and all available clinical data. Read More

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http://dx.doi.org/10.1007/s40290-017-0197-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5539271PMC
July 2017
3 Reads

The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore.

Pharmaceut Med 2017 15;31(1):21-30. Epub 2016 Dec 15.

Global Development Programme, Centre for Innovation in Regulatory Science, 77 Hatton Garden, London, EC1N 8JS UK.

Objective: This study outlines the current regulatory review process and good review practices (GRevPs) at the Jordan Food and Drug Administration (JFDA) and compares them with those of regulatory agencies in Australia, Canada, Saudi Arabia and Singapore to gauge how well the JFDA is performing. We identify opportunities for further development of the JFDA as a key global reference agency.

Methods: Personnel within the JFDA completed a questionnaire comprising four sections: organisation, key milestones, review timelines, and GRevPs. Read More

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http://dx.doi.org/10.1007/s40290-016-0172-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5429368PMC
December 2016
37 Reads

Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder.

Pharmaceut Med 2017 29;31(2):101-112. Epub 2017 Mar 29.

School of Life and Medical Sciences, University of Hertfordshire, Hertfordshire, AL10 9AB UK.

Introduction: Additional risk minimisation measures (aRMMs) for medicinal products are necessary to address specific important safety issues which may not be practically achieved through routine risk management measures alone. The implementation and determination of effectiveness for aRMMs can be a challenge as it involves multiple stakeholders. It is therefore important to have concise objectives to avoid undue burden on patients, healthcare professionals and the healthcare system. Read More

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http://link.springer.com/10.1007/s40290-017-0184-8
Publisher Site
http://dx.doi.org/10.1007/s40290-017-0184-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5376384PMC
March 2017
21 Reads

Challenging Perceptions About Oncology Product Pricing in Breast and Colorectal Cancer.

Pharmaceut Med 2016 10;30(6):321-326. Epub 2016 Nov 10.

Charles River Associates, Life Sciences, 8 Finsbury Circus, London, EC2M 7EA UK.

Although significant progress has been made in the past decade in the treatment of both common and rare cancers, there has been significant concerns about the cost, and especially the value, of certain new oncology drugs. These concerns touch upon a number of issues regarding the price of these medicines, the value they deliver and the ability of healthcare systems to fund them. This paper looks at these perceptions and the extent to which they apply across different oncology products. Read More

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http://dx.doi.org/10.1007/s40290-016-0167-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5110579PMC
November 2016
3 Reads

Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness.

Pharmaceut Med 2016 19;30(5):263-276. Epub 2016 Aug 19.

Center for Systematic Review in Health Policy and Systems Research (SPARK), American University of Beirut, Beirut, Lebanon ; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON Canada ; Department of Internal Medicine, American University of Beirut, Beirut, Lebanon ; Department of Epidemiology and Population Health, Faculty of Health Sciences, American University of Beirut, Beirut, Lebanon.

Background: A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation.

Objective: The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting. Read More

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http://dx.doi.org/10.1007/s40290-016-0156-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5045490PMC
August 2016
27 Reads

A Method for Retrieval of Adverse Event Terms in Clinical Trial Databases Using Standardised MedDRA Queries.

Pharmaceut Med 2016 Apr;30(2):103-108

Division of Neurology Products (DNP), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), White Oak, Bldg. 22 Rm. 4218 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.

Background: Standardized MedDRA Queries (SMQs) are sets of terms determined by experts that are used to identify adverse events (AEs) related to different disease processes. Their use can be challenging because most SMQs have 50 to 100 preferred terms and AE databases can have many thousands of events.

Aim: The aim of this study is to develop a technique where AEs corresponding to preferred terms in SMQs may be easily detected. Read More

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4886503PMC
April 2016
27 Reads

The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia in Comparison with Australia, Canada and Singapore.

Pharmaceut Med 2016;30:37-47. Epub 2015 Nov 6.

Centre for Innovation in Regulatory Science, 77 Hatton Garden, London, EC1N 8JS UK ; School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, Wales.

Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and Singapore and identifies opportunities for developing the SFDA as a Regional Centre of Excellence.

Methods: A questionnaire completed by the SFDA included data regarding the organisation, key milestones, review timelines, and good review practices of the agency. Similar information was obtained within the same timeframe (2014/2015) through the same standard questionnaire regarding the processes and practices for Health Canada, Singapore's Health Sciences Authority, and Australia's Therapeutic Goods Administration. Read More

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http://dx.doi.org/10.1007/s40290-015-0124-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4718932PMC
November 2015
20 Reads

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US.

Pharmaceut Med 2015;29(6):331-340. Epub 2015 Aug 5.

Epidemico, Inc., 883 Boylston St Suite 2, Boston, MA 02116 USA.

Background: Preparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40 min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved. Read More

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http://dx.doi.org/10.1007/s40290-015-0106-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4656696PMC
August 2015
20 Reads
5 Citations

Big Data in Pharmaceutical R&D: Creating a Sustainable R&D Engine.

Authors:
Peter Tormay

Pharmaceut Med 2015;29(2):87-92

Capish Nordic AB, Stortorget 9, 211 22 Malmö, Sweden.

Over the last 20 years, productivity in the pharmaceutical industry has been diminishing because of constantly increasing costs while output has overall been stagnant. Despite many efforts, productivity remains a challenge within the industry. At the same time, healthcare providers quite rightly require better value for money and clear evidence that new drugs are better than the current standard of care, making a complex situation even more complex. Read More

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http://dx.doi.org/10.1007/s40290-015-0090-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4392111PMC
January 2015
11 Reads

Global Access Programs: A Collaborative Approach for Effective Implementation and Management.

Pharmaceut Med 2015;29(2):79-85

Clinigen Healthcare Limited, Pitcairn House, Crown Square, Centrum 100, Burton-on-Trent, Staffordshire DE14 2WW UK.

Global access programs (GAPs) provide access to medicinal products for patients with serious medical conditions and no commercially available treatment options. Providing early access to medicines can be challenging for a pharmaceutical company. The demand for a GAP often occurs at a time when other activities are the prime focus, such as delivery of pivotal clinical trials or gaining of marketing authorization. Read More

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http://link.springer.com/10.1007/s40290-015-0091-9
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http://dx.doi.org/10.1007/s40290-015-0091-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4392108PMC
January 2015
85 Reads

Do Molecular Structures of Migraine Drugs Point to a Common Cause of this Elusive Disease and Suggest Future Drug Designs?

Pharmaceut Med 2015;29(1):1-5

Department of Chemistry, University of Canterbury, Private Bag 4800, Christchurch, 8140 New Zealand.

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http://dx.doi.org/10.1007/s40290-014-0075-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4339779PMC
January 2015
2 Reads

Acquiring Pharmaceutical Industry Assets in the UK: 1 + 1 = 1?

Pharmaceut Med 2014 ;28(5):245-248

Medical Technology Research Group, LSE Health, Department of Social Policy, London School of Economics and Political Science, Houghton Street, London, WC2A 2AE UK.

The recent AstraZeneca takeover bid from Pfizer puts pharmaceutical R&D once again on the public agenda. Three pertinent questions are (a) what can be expected from this acquisition, (b) what are the implications for the UK economy and science base, and (c) whether such a deal should go ahead. Although the key driver behind this acquisition would be an improvement in company performance and shareholder value, past evidence suggests that mergers and acquisitions (M&A) of large pharmaceutical companies imply a neutral net effect on productivity, if not a decline, with employment decreasing and R&D spend following a similar trend. Read More

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http://dx.doi.org/10.1007/s40290-014-0066-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4203995PMC
January 2014
8 Reads

New Financial and Research Models for Pediatric Orphan Drug Development - Focus on the NCATS TRND Program.

Pharmaceut Med 2014 Feb;28(1):1-6

Therapeutics for Rare and Neglected Diseases (TRND) Program, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Rockville, MD, USA.

While there are approximately 7,000 identified human diseases considered as "rare" based on population prevalence or incidence, the cumulative impact runs into the millions of patients globally. Although the genetic underpinnings of more than 2,000 rare diseases have been elucidated, there remains a paucity of therapeutic options, frequently due to lack of commercial interest. Development programs suffer high attrition within the so-called "Valley of Death," in which the risks of scientific failure are still too high to justify the increasing development costs. Read More

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http://dx.doi.org/10.1007/s40290-014-0047-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4023479PMC
February 2014
7 Reads

Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?

Pharmaceut Med 2013 Apr;27(2):75-82

EU Regulatory Policies, F. Hoffmann-La Roche Ltd., Drug Regulatory Affairs, PDRA, Grenzacherstrasse 124, 4070 Basel, Switzerland.

A perspective from the innovative industry is provided in this article about the long awaited legal proposal for a Clinical Trial Regulation ("Proposal"), adopted in July 2012. With this Proposal, the European Commission reacted to a call by all stakeholders for more harmonization and streamlining of the provisions for conducting clinical trials in the EU. Discrepant approaches between Member States, a failure to respect legal timelines, and a lack of formal coordination mechanisms within and between Member States have resulted in an increased workload for the industry and contributed to a decline in Europe's attractiveness as a place to carry out research and development. Read More

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http://dx.doi.org/10.1007/s40290-013-0012-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3622747PMC
April 2013
4 Reads

Advances in Gene Delivery Systems.

Pharmaceut Med 2011 Oct;25(5):293-306

Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.

The transfer of genes into cells, both in vitro and in vivo, is critical for studying gene function and conducting gene therapy. Methods that utilize viral and nonviral vectors, as well as physical approaches, have been explored. Viral vector-mediated gene transfer employs replication-deficient viruses such as retro-virus, adenovirus, adeno-associated virus and herpes simplex virus. Read More

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http://dx.doi.org/10.2165/11594020-000000000-00000DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3245684PMC
October 2011
6 Reads

Analysis of US Food and Drug Administration Warning Letters: False Promotional Claims Relating to Prescription and Over-the-Counter Medications.

Pharmaceut Med 2008 Mar;22(2)

Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

Background: Recent studies have suggested that there has been an increase in the number of 'warning letters' issued by the US Food and Drug Administration (FDA) despite the publication of the FDA advertising guidelines. However, limited information is available on the description of warning letters. The objective of this study was to analyse the frequency and content of FDA warning letters in relation to promotional claims and discuss the influence of regulatory and industry constraints on promotion. Read More

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http://dx.doi.org/10.1007/BF03256691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3864040PMC
March 2008
3 Reads

Electronic Diaries: Appraisal and Current Status.

Authors:
Joan E Broderick

Pharmaceut Med 2008 Jan;22(2):69-74

Dept. of Psychiatry & Behavioral Science Stony Brook University Stony Brook, New York.

The recent explosion of technology has moved the field of patient reported outcomes (PROs) into a new era. Use of paper-and-pencil questionnaires administered before and after treatment has been eclipsed by highly sophisticated random prompts for symptom ratings at multiple points throughout the day, a method known as ecological momentary assessment (EMA). During the last 25 years, research has demonstrated that retrospective ratings are subject to a variety of cognitive heuristics that can distort the report. Read More

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2796846PMC
January 2008
2 Reads
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