scholarly journals RADIANCE Cybersecurity Plan: Generic Version

2020 ◽  
Author(s):  
M. V. McCarty ◽  
S. R. Mix ◽  
M. R. Knight ◽  
John P. Eddy ◽  
Jay Tillay Johnson ◽  
...  
Keyword(s):  
Generic Version

FDA approves first generic version of EpiPen

2018 ◽  
Author(s):  
Keyword(s):  
Generic Version

scholarly journals What is associated with increased side effects and lower perceived efficacy following switching to a generic medicine? A New Zealand cross-sectional patient survey

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023667 ◽  
Author(s):  
Kate MacKrill ◽  
Keith J Petrie
Keyword(s):  
New Zealand ◽  
Side Effects ◽  
Generic Version ◽  
Drug Efficacy ◽  
Patient Survey ◽  
Generic Medicine ◽  
Cross Sectional Survey ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Perceived Efficacy

ObjectiveFollowing a switch from either a generic or branded antidepressant (venlafaxine) to a new generic, we investigated the factors associated with a preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic drug.DesignA cross-sectional survey of patients switched to a new generic.SettingPatients accessing venlafaxine information online from the New Zealand government pharmaceuticals funding website.Participants310 patients, comprising 205 originally on branded venlafaxine and 105 previously taking a generic version.Main outcome measuresAn online questionnaire assessing demographic factors, perceived sensitivity to medicines, trust in pharmaceutical agencies, sources of switch information, preference for branded medicine, new medicine perceptions, side effects and efficacy ratings.ResultsPreference for branded medicine was significantly stronger in older patients (OR=1.04, 95% CI 1.01 to 1.05), those taking branded venlafaxine (OR=2.02, 95% CI 1.13 to 3.64) and patients with a higher perceived sensitivity to medicine (OR=1.23, 95% CI 1.06 to 1.19). Different factors predicted side effects in those switching from the branded and those switching from the generic venlafaxine. Trust in pharmaceutical agencies and the number of side effects were significant predictors of efficacy ratings of the new generic in both patients switching from a branded and those switching from a generic version of venlafaxine.ConclusionsIn patients switching from a branded medicine and those already taking a generic, different demographic and psychological factors are associated with preference for branded medicine, side effect reporting and perceived efficacy of the new drug. When switching to new generic, there appears to be a close bidirectional relationship between the experience of side effects and perceived drug efficacy. Trust in pharmaceutical agencies impacts directly on perceived efficacy and increasing such trust could reduce the nocebo response following a generic switch.

FDA approves first generic version of Tamiflu

2016 ◽  
Vol 4 (10) ◽  
pp. 775 ◽  
Author(s):  
Patricia Lobo
Keyword(s):  
Generic Version

Psychometric properties of the Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)

2018 ◽  
Vol 26 (2) ◽  
pp. 106-112 ◽  
Author(s):  
Weihong Qiu ◽  
Hongli Guan ◽  
Zhaocong Chen ◽  
Yong Yu ◽  
Huixiang Wu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychometric Properties ◽  
Generic Version ◽  
Chinese Version ◽  
Quality Of Life Scale ◽  
Life Scale

Company News

2002 ◽  
Vol 06 (22) ◽  
pp. 820-828
Keyword(s):  
Health Education ◽  
Clinical Studies ◽  
Oral Therapy ◽  
North China ◽  
Generic Version ◽  
Life Sciences

ResMed Releases New Mask and Receives US Award. VRI BioMedical Launches First Product in US. North China Pharmaceutical to Export Genetic Medicines. Ranbaxy Gets US Approval for Generic Version of Augmentin. Dr. Reddy’s Launches Health Education Foundation. Nippon Boehringer Ingelheim to Make Oral Therapy for Hypertension. NicOx and AstraZeneca to Develop AZD3582 in Japan. Yamanouchi Invests in Avalar Bioventures Fund. Kyowa Hakko Starts Clinical Studies for Antiasthmatic Agent. Auckland Company Develops Mole-map Camera. TNT to Launch Life Sciences Excellence Center in Singapore.

scholarly journals Long-Term Stability Comparison between an Original and a Generic Version of Piperacillin/Tazobactam in Dextrose 5 % Infusion Polyolefin Bags at 5 ± 3 °C after Microwave Freeze-Thaw Treatment

2018 ◽  
Vol 3 (3) ◽  
pp. 143-151
Author(s):  
Sophie Huvelle ◽  
Marie Godet ◽  
Laurence Galanti ◽  
Mélanie Closset ◽  
Benoît Bihin ◽  
...  
Keyword(s):  
Generic Version ◽  
Generic Product ◽  
Brand Name ◽  
Term Stability ◽  
Long Term Stability ◽  
Ph Values ◽  
Lower Confidence ◽  
The Stability ◽  
Aseptic Conditions

AbstractBackgroundPiperacillin-Tazobactam is frequently infused in hospitals. The use of a generic version was considered after the out of stock of the brand name Tazocin®. The stability of 4 g of Tazocin®in 120 mL of dextrose 5 % (D5) was demonstrated during 35 days at 5 °C ± 3 °C after freezing (−20 °C) and microwave thawing (FMT). The aim of the study was to investigate and compare the long-term stability of Tazocin®and a generic product in the same conditions.MethodsFive polyolefin bags of 4 g of Piperacillin/Tazobactam®Sandoz and 5 bags of 4 g of Tazocin®were prepared under aseptic conditions in 120 mL of D5 and stored 3 months at 20 °C then thawed and stored 58 days at 5 ± 3 °C.Spectrophotometric absorbance at different wavelengths, pH measurement, visual and microscopic observations were also performed.The concentrations were measured by HPLC, at 211 nm for tazobactam and 230 nm for piperacilline.ResultsNo significant change in pH values or optic densities, no crystals were detected. The lower confidence limit at 95 % of the concentration for the solutions remains superior to 90 % of the initial concentration until 58 days of storage at 5 ± 3 °C.ConclusionUnder these conditions, 4 g/120 mL of Piperacillin/Tazobactam®Sandoz or Tazocin®in D5 infusion in polyolefin bags remains stable at least for 58 days at 5 ± 3 °C after FMT

P0638COMPARISON OF CIRCUIT PATENCY AND EXCHANGE RATES BETWEEN THE ORIGINAL PRODUCTS AND THE GENERIC VERSIONS OF NAFAMOSTAT MESILATE IN ACUTE KIDNEY INJURY RECEIVING CONTINOUS RENAL REPLACEMENT THERAPY

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Ho Sik Shin ◽  
Jisu Kim ◽  
Haesu Jeon ◽  
Ye Na Kim ◽  
Yeonsoon Jung ◽  
...  
Keyword(s):  
Acute Kidney Injury ◽  
Renal Replacement Therapy ◽  
Exchange Rates ◽  
Continuous Renal Replacement Therapy ◽  
Replacement Therapy ◽  
Generic Version ◽  
Kidney Injury ◽  
Hemorrhagic Diathesis ◽  
Nafamostat Mesilate ◽  
Original Product

Abstract Background and Aims The generic versions have the same main component as the original products. But, due to the difference in additives or the level of impurities, it is questionable the the generic versions are completely identical to the original products. Nafamostat mesilate has been widely used as an anticoagulation in continuous renal replacement therapy (CRRT) with hemorrhagic diathesis. In this study, we performed comparison of circuit patency and exchange rates between the original products and the generic versions of Nafamostat mesilate in acute kidney injury patients receiving continuous renal replacement therapy Method We have conducted retrospective studies to compare the original product of nafamostat mesilate (n=732) with the generic version (n=328) on the CRRT running time. Results CRRT fiter life time of the generic version group was shorter than that of original product group although that was not significantly. Conclusion When generic versions of nafamostat mesilate are adopted in a hospital formulary, it must be emphasized that the effect these versions may be not completely identical to that of the original products.

scholarly journals Biosimilar medical products – licensing, pharmacovigilance and interchangeability

PRILOZI ◽  
2016 ◽  
Vol 37 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Aleksandra Grozdanova ◽  
Katerina Ancevska Netkovska ◽  
Zoran Sterjev ◽  
Zorica Naumovska ◽  
Rubin Zarevski ◽  
...  
Keyword(s):  
Generic Version ◽  
Financial Sustainability ◽  
Clinical Use ◽  
Patient Access ◽  
Biological Product ◽  
Regulatory Requirements ◽  
Complex Molecules ◽  
Medical Products ◽  
Biological Medicine ◽  
Improve Patient

Abstract The use of biological medicine has significantly increased in recent decades and has made substantial contributions to improving the effectiveness of therapies in many diseases. The expiration of patents of biological innovative medicines enables copies of those drugs called similar biological products (biosimilars) to be approved by regulatory authorities and to enter in clinical use. Biosimilars are comparable but not identical and are not a generic version of the innovator biological product. Although biosimilars undergo rigorous characterization as well as clinical studies to prove their safety and effectiveness, specific regulatory requirements for registration apply in the case of biosimilars. They are highly complex molecules and small changes in the production process can have major implications in its safety and effectiveness profile. The availability of biosimilars enhances competition, with the potential to improve patient access to biological medicines and to contribute to the financial sustainability of healthcare systems. In order to be certain that a biosimilar reaches its potential in clinical use, an intensive pharmacovigilance monitoring system must be established in order to prove the true similarity between the original biologic and its biosimilar. There is a need for further guidance and resolution of the ongoing discussions on biosimilar labelling, naming, pharmacovigilance and substitution in order to ensure effective and appropriate use of biosimilars in clinical practice.

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