generic drug
“Comparative Study of Generic Drug Approval Process in EU, USA and CHINA” by Rahul Raj .S, N. Vishal Gupta, India.
... Generic drug registration is a very strenuous and complicated process in many ...China. Generic drugs in EU are approved under the Marketing Authorization Application and in US they are approved ...
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A comparison of generic drug prices in seven European countries: a methodological analysis
... a drug can expire at different times across high-income countries depending on when the drug was approved in each ...and generic drug prices [34, 35]. The speed of generic entry, in ...
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A descriptive cross-sectional study to evaluate the Generic Drug User Fee Act: A boon or loss to the Indian generic pharmaceutical industry
... the Generic Drug User Fee Act (GDUFA) implication on the Indian generic pharmaceutical industry based on the primary ...the generic industry of India, were the study participants and were ...
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Effects of hospital generic drug substitution on diabetes therapy
... four generic brands of metformin from four different ...branded drug I ended on July 12, 2004; generic drug II was prescribed from July 13, 2004 to November 2, 2005; generic drug ...
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A REVIEW OF INFLUENCE OF THE GENERIC DRUG USER FEES ACT UPON THE EXPORT FROM THE INDIAN PHARMACEUTICAL INDUSTRY
... and generic drug export on the implementation of the GDUFA had ignited the export rate making India the largest producer of bulk drugs in the ...and generic drug globally has increased by 30% ...
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Forces influencing generic drug development in the United States: a narrative review
... increase generic drug utilization in Europe [8] (Table ...influence generic prescribing by disseminating educational ...increasing generic drug utilization through the use of positive ...
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Merger mania: mergers and acquisitions in the generic drug sector from 1995 to 2016
... four generic pharmaceutical manufacturing firms in the United States made only ...largest generic company, Pfizer Global Established Products, represented 9% of the glo- bal market value for generics and ...
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Determinants of generic drug substitution in Switzerland
... The policy measures recently introduced in Switzerland - 20% co-payment for brand drugs, minimal savings between originals and generics - should be effective since the relative price difference and out-of-pocket ...
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A STUDY ON THE REGULATORY REQUIREMENTS FOR GENERIC DRUG PRODUCTS IN USA, SOUTH AFRICA AND RUSSIA
... The pharmaceutical area is enormously regulated industry, has to comply with many rules and regu- lations set and enforced by the government in order to protect the health and well being of the patients and the public. ...
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GENERIC DRUG USER FEE: AN OVERVIEW
... of generic drug manufacturing, supply and testing, and a growing workload that has far outpaced USFDA’s resources has created new ...propose generic drug user fee to address the need for ...
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Pharmacists’ views and reported practices in relation to a new generic drug substitution policy in Lebanon: a mixed methods study
... performing generic substitution for many prescriptions that allowed substitution; a fre- quently reported reason related to the poor incentive system in place to encourage generic ...of generic drugs ...
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A COMPREHENSIVE STUDY ON THE DOSSIER PREPARATION FOR SUBMISSION OF GENERIC DRUG TO EUROPE IN CTD FORMAT
... The stress testing should be performed in phase III of regulatory submission process. Stress studies should be done in different pH solutions, in the presence of oxygen and light, and at elevated temperatures and ...
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Comparative fasting bioavailability of two clopidogrel formulations in healthy Mediterranean volunteers: an in vitro–in vivo correlation
... name drug is defined as a drug marketed under a proprietary, trademark-protected name and a generic drug is the same as a brand name drug in terms of active ingredient, dosage form, ...
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The adoption of generic drugs by a hospital: effects on drug dispensation among community pharmacies
... of generic drug use by pharmacies, many health insurance pharmacies were not actively handling generic drugs owing to the fact that nearby medical facilities were not actively using ge- nerics ...
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REGULATORY REQUIREMENTS FOR REGISTRATION OF GENERIC DRUGS IN “BRICS” COUNTRIESG.Ravi Kiran*, M.V.Nagabhushanam, Brahmaiah Bonthagarala, D.Nagarjuna ReddyDOWNLOAD/VIEW
... The purpose of the study was to compare generic drug registration process and to find out the differences, lacunae among the guidelines. Brazil, Russia, India, China and South Africa are typically rendered ...
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Generic Drugs and Bioequivalence for its Approval
... any generic drug that is bioequivalent to its trade-name counterpart may be interchanged with ...the generic drug may be the only form ...for generic drugs whenever ...trade-name ...
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Factors influencing the use of the “not for generic substitution” mention for prescriptions in primary care: a survey with general practitioners
... of generic drugs, with an additional cost of € 100 million in France ...The generic market in Europe ranges from 17% in Switzerland to 83% in the United Kingdom ...perceive drug sub- stitution as ...
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Analysis of the Factors Influencing Enterprise and Government Participation in the Medicines Patent Pool Based on System Dynamics Model
... selected generic drug price, pooling subsidy, royalty rate, and enterprise scale as key factors influencing an enterprise’s decision to the ...that generic drug price was the key factor ...
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CHALLENGES IN REGULATORY FILING OF GENERIC PRODUCTS IN EUROPE AND MALAYSIA
... compare generic drug registration and requirements in ASEAN countries & to find out the differences in ...scale generic companies in these countries unless their manufacturing procedures are well ...
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Drug Research and Development Incentives Under a Changing Exclusivity Environment: An Event Study approach.
... the drug industry have also been instrumental in the development of this industry over the ...and Drug Administration (FDA) in 1938, various important reforms have followed such as the 1962 amendments to ...
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