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Efficacy of generic drugs

Lawrence C Ku, Huali Wu, Rachel G Greenberg, Kevin D Hill, Daniel Gonzalez, Christoph P Hornik, Alysha Berezny, Jeffrey T Guptill, Wenlei Jiang, Nan Zheng, Michael Cohen-Wolkowiez, Chiara Melloni
BACKGROUND: Defining a drug's therapeutic index (TI) is important for patient safety and regulating the development of generic drugs. For many drugs, the TI is unknown. A systematic approach was developed to characterize the TI of a drug using therapeutic drug monitoring and electronic health record (EHR) data with pharmacokinetic (PK) modeling. This approach was first tested on phenytoin, which has a known TI, and then applied to lamotrigine, which lacks a defined TI. METHODS: Retrospective EHR data from patients in a tertiary hospital were used to develop phenytoin and lamotrigine population PK models and to identify adverse events (anemia, thrombocytopenia, and leukopenia) and efficacy outcomes (seizure-free)...
October 19, 2016: Therapeutic Drug Monitoring
Aastha Gupta, Sandeep Juneja, Marco Vitoria, Vincent Habiyambere, Boniface Dongmo Nguimfack, Meg Doherty, Daniel Low-Beer
With anti-retroviral treatment (ART) scale-up set to continue over the next few years it is of key importance that manufacturers and planners in low- and middle-income countries (LMICs) hardest hit by the HIV/AIDS pandemic are able to anticipate and respond to future changes to treatment regimens, generics pipeline and demand, in order to secure continued access to all ARV medicines required. We did a forecast analysis, using secondary WHO and UNAIDS data sources, to estimate the number of people living with HIV (PLHIV) and the market share and demand for a range of new and existing ARV drugs in LMICs up to 2025...
2016: PloS One
Getahun E Agga, John W Schmidt, Terrance M Arthur
: Concerns have been raised that in-feed chlortetracycline (CTC) may increase antimicrobial resistance (AMR), specifically tetracycline-resistant (TET(r)) Escherichia coli, and third-generation cephalosporin-resistant (3GC(r)) E. coli We evaluated the impact of a 5-day in-feed CTC prophylaxis on animal health, TET(r) E. coli, and 3GC(r) E. coli A "control group" of cattle (n = 150) received no CTC, while a "CTC group" (n = 150) received in-feed CTC (10 mg/lb of body weight/day) from the 5th to the 9th day after feedlot arrival...
October 7, 2016: Applied and Environmental Microbiology
Lotus Mallbris, Julian Davies, Andrew Glasebrook, Ying Tang, Wolfgang Glaesner, Brian J Nickoloff
In recent years, a large number of therapeutic monoclonal antibodies have come to market to treat a variety of conditions including patients with immune-mediated chronic inflammation. Distinguishing the relative clinical efficacy and safety profiles of one monoclonal antibody relative to another can be difficult and complex due to different clinical designs and paucity of head-to-head comparator studies. One distinguishing feature in interpreting clinical trial data by dermatologists may begin by determining whether a monoclonal antibody is fully human or humanized, which can be discerned by the generic name of the drug...
July 2016: Journal of Clinical and Aesthetic Dermatology
Harpreet S Sidhu, Akshay Sadhotra
Antiepileptic drugs (AEDs) are extensively used worldwide to treat a wide range of disorders other than epilepsy, such as neuropathic pain, migraine, and bipolar disorder. Due to this situation more than 20 new third-generation AEDs have been introduced in the market recently. The future design of new AEDs must also have potential to help in the non-epileptic disorders. The wide acceptance of second generation AEDs for the management of various non-epileptic disorders has caused the emergence of generics in the market...
2016: Frontiers in Pharmacology
Mostafa Yakoot, Alaa M Abdo, Ahmed Yousry, Sherine Helmy
BACKGROUND: This is the second and final report for our study designed to compare two generic sofosbuvir products for the degree and speed of virologic response to a dual anti-hepatitis C virus (HCV) treatment protocol. We aimed to test the applicability of the early virus response kinetics and the very rapid virologic response (vRVR) rate as quick outcome measures for accelerated comparative efficacy studies and as a foundation for a personalized response-guided therapy. METHODS: Fifty eligible chronic HCV patients were randomized to either one of two generic sofosbuvir products (Gratisovir or Grateziano) at a daily dose of one 400 mg tablet plus a weight-based ribavirin dose...
2016: Drug Design, Development and Therapy
Yao Liu, Omar Galárraga
BACKGROUND: The efficacy of low- and middle-income countries' (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. METHODS: Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO)...
September 1, 2016: Health Policy and Planning
Edward C Oldfield Iv, Parth J Parekh, David A Johnson
INTRODUCTION: Gastroesophageal reflux disease (GERD) is a common clinical condition afflicting millions of patients, whose prevalence continues to rise owing to the aging population and increasing burden of comorbid conditions, such as obesity. Currently, the mainstay of therapy for GERD is treatment with proton pump inhibitors (PPIs). Despite their overall efficacy, safety, and tolerability, there are still a considerable number of patients who fail treatment and have refractory symptoms to PPI therapy...
August 31, 2016: Expert Review of Gastroenterology & Hepatology
Evangelos Tsipotis, Navin R Gupta, Gowri Raman, Elias Zintzaras, Bertrand L Jaber
BACKGROUND: Concerns exist over the extrapolation of bioavailability studies of generic immunosuppressive drugs in healthy volunteers, regarding their efficacy and safety in kidney transplant recipients. We conducted a meta-analysis of trials examining the bioavailability of generic (test) immunosuppressive drugs relative to their brand (reference) counterparts in healthy volunteers, based on the US Food and Drug Administration requirements for approval of generics, and their efficacy and safety in kidney transplant recipients...
2016: American Journal of Nephrology
Maria Teresa Herdeiro, Paulo D Bastos, António Teixeira-Rodrigues, Fátima Roque
PURPOSE: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED)...
September 2016: Clinical Therapeutics
Michael A Partridge, Shobha Purushothama, Chinnasamy Elango, Yanmei Lu
Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety. It is critical to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and nonneutralizing anti-drug antibodies, especially in clinical phases of drug development. Different assay methodologies have been used to detect all anti-drug antibodies, including ELISA, radioimmunoassay, surface plasmon resonance, and electrochemiluminescence-based technologies...
2016: Journal of Immunology Research
Gavin McLaughlin, Noreen Morris, Pierce V Kavanagh, John D Power, Geraldine Dowling, Brendan Twamley, John O'Brien, Brian Talbot, Donna Walther, John S Partilla, Michael H Baumann, Simon D Brandt
3-Methoxy-2-(methylamino)-1-(4-methylphenyl)propan-1-one (mexedrone) appeared in 2015 and was advertised by UK Internet retailers as a non-controlled mephedrone derivative (2-(methylamino)-1-(4-methylphenyl)propan-1-one), which was of particular interest to countries who operate generic drugs legislation. This study describes the synthesis and analytical characterization of mexedrone and differentiation from its isomer, N-methoxymephedrone, which was predicted to be a suitable candidate before the identity of mexedrone was revealed...
August 15, 2016: Drug Testing and Analysis
Sarah L E Colgan, Kate Faasse, Jennifer A Pereira, Andrew Grey, Keith J Petrie
OBJECTIVE: Generic medicines provide a safe and economical medical treatment and are used routinely throughout the world. However, a significant proportion of individuals view generic medicines as less safe, less effective and of lower quality compared with their equivalent branded medicines. This study aimed to investigate the effect of an educational intervention on improving perceptions and perceived efficacy of generic medicines. METHOD: Seventy participants who experienced frequent tension headaches were randomized to receive an educational video about generic medicines or a control video...
November 2016: Health Psychology: Official Journal of the Division of Health Psychology, American Psychological Association
Laura Park-Wyllie, Judy Van Stralen, Doron Almagor, Wendy Dobson-Belaire, Katia Charland, Andrew Smith, Jacques Le Lorier
PURPOSE: We conducted a retrospective cohort study to compare medication use patterns of a long-acting extended-release methylphenidate (Osmotic Release Oral System [OROS(®)] methylphenidate, CONCERTA(®)) and Teva-methylphenidate (methylphenidate ER-C), a generic drug determined by the Canadian regulatory authority, Health Canada, to be bioequivalent to OROS(®) methylphenidate. METHODS: We established an OROS(®) methylphenidate-experienced and new-user population cohort to compare medication use patterns, including medication persistence, duration of therapy, and treatment-switching patterns...
August 2016: Clinical Therapeutics
Gheorghe Doros, Philip T Lavin, Michael Daley, Larry E Miller
Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon indistinguishable characteristics in comparison to an approved branded hyaluronic acid (Supartz®/Supartz FX™)...
2016: Medical Devices: Evidence and Research
Anandhasayanam Aravamuthan, Mohanavalli Arputhavanan, Kannan Subramaniam, Sam Johnson Udaya Chander J
BACKGROUND: Due to the lack of clear, comprehensive, and rational drug policy, the production of pharmaceutical preparations in India is distorted for the most part. Indian markets are flooded with more than 70,000 formulations, compared to approximately 350 formulations listed in the World Health Organization (WHO) Essential Drug List. Studies have indicated that majority of prescriptions in India are of drugs of "doubtful efficacy." To promote rational drug use in developing countries, assessment of drug use patterns with the WHO drug use indicators is becoming increasingly necessary...
2017: Journal of Pharmaceutical Policy and Practice
Abdel Naser Zaid, Naim Kittana, Ayman Mousa, Nadia Ghazal, Rana Bustami
BACKGROUND: Treatment of neuropathic pain has always been challenging, not only from the pharmaco-therapeutic/toxicological point of view, but also due to the unpredictable pharmacokinetic (PK) variations among different generic formulations of the same drug, which require further dose optimization. OBJECTIVES: This progressive work aims to evaluate the bioequivalence (BE) of a generic product of 150 mg pregabalin capsule (antineuropathic drug) vs. the reference brand drug Lyrica<sup>®</sup>...
September 2016: International Journal of Clinical Pharmacology and Therapeutics
Jorge Correale, Erwin Chiquete, Alexey Boyko, Roy G Beran, Jorge Barahona Strauch, Snezana Milojevic, Nadina Frider
Both proprietary and nonproprietary medicines are expected to undergo rigorous preapproval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Nonproprietary (also known as copy, or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower the cost and, thus, increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy...
2016: Drug Design, Development and Therapy
Maria Elena Flacco, Lamberto Manzoli, Stefania Boccia, Anna Puggina, Annalisa Rosso, Carolina Marzuillo, Giacomo Scaioli, Maria Rosaria Gualano, Walter Ricciardi, Paolo Villari, John P A Ioannidis
OBJECTIVES: To evaluate the research agenda of registered randomized trials comparing generic and brand-name drugs in terms of who sponsors them, whether they are published promptly, and whether they find favorable results. METHODS: We included randomized trials comparing the safety or efficacy of brand-name vs generic medications that were registered in or other registries from January 1, 2000, through July 31, 2015. To identify published articles or results generated from such trials, we searched PubMed, Scopus, Google, and registry databases...
August 2016: Mayo Clinic Proceedings
Oliver Langer
Several membrane transporters belonging to the adenosine triphosphate-binding cassette (ABC) and solute carrier (SLC) families can transport drugs and drug metabolites and thereby exert an effect on drug absorption, distribution, and excretion, which may potentially lead to transporter-mediated drug-drug interactions (DDIs). Some transporter-mediated DDIs may lead to changes in organ distribution of drugs (eg, brain, liver, kidneys) without affecting plasma concentrations. Positron emission tomography (PET) is a noninvasive imaging method that allows studying of the distribution of radiolabeled drugs to different organs and tissues and is therefore the method of choice to quantitatively assess transporter-mediated DDIs on a tissue level...
July 2016: Journal of Clinical Pharmacology
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