Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. - Wikidata - awgldk - TriplyDB

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.

http://www.wikidata.org/entity/Q33506237

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What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?Efficiency of Original versus Generic Intravenous Iron Formulations in Patients on Haemodialysis Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy.Potential Clinical and Economic Impact of Switching Branded Medications to Generics.Does the placebo effect modulate drug bioavailability? Randomized cross-over studies of three drugs.How Do Clinicians Adjust Lamotrigine Doses and Use Lamotrigine Blood Levels?-A Q-PULSE Survey.Refilling and switching of antiepileptic drugs and seizure-related events A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study.A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients?Paying physicians to prescribe generic drugs and follow-on biologics in the United States.The backlash against bioequivalence and the interchangeability of brand-name and generic drugs.An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences.Narrow therapeutic index drugs: a clinical pharmacological consideration to flecainide.Comment on: Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe by Johnston et al Likelihood approach for evaluating bioequivalence of highly variable drugs.Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.Pharmaceutical Evaluation of Cefuroxime Axetil Tablets Available in Drug Market of Pakistan.Generic substitution of lamotrigine among medicaid patients with diverse indications: a cohort-crossover study.International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.Clinical outcomes after conversion from brand-name tacrolimus (prograf) to a generic formulation in renal transplant recipients: a retrospective cohort study Safety and efficacy of generic drugs with respect to brand formulation.Batch-to-batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial Requirements for generic antiepileptic medicines: a clinical perspective.Generic maintenance immunosuppression in solid organ transplant recipients.Generic substitution of antiepileptic drugs: a systematic review of prospective and retrospective studies.Ezogabine: an evaluation of its efficacy and safety as adjunctive therapy for partial-onset seizures in adults.Management of advanced lung cancer in resource-constrained settings: a perspective from India.Demand-side policies to encourage the use of generic medicines: an overview.Bioequivalence Between Generic and Branded Lamotrigine in People With Epilepsy: The EQUIGEN Randomized Clinical Trial.Generic immunosuppression in transplantation: current evidence and controversial issues.Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.Will purple become the new orange? The new FDA purple book for biologics: what does the future hold?Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis.Safety of switching from brand-name to generic levetiracetam in patients with epilepsy.A Cost Analysis of the Jan Aushadhi Scheme in India.

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P2860

Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.

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2009 nî lūn-bûn

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2009 թուականի Սեպտեմբերին հրատարակուած գիտական յօդուած

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Barbara M Davit

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Dale P Conner

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Devvrat T Patel

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Gary J Buehler

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Janet Woodcock

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Lawrence X Yu

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Patrick E Nwakama

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Sam H Haidar

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Yongsheng Yang

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A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability

Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applications

Drug substitution in transplantation: a National Kidney Foundation White Paper.

Formulation substitution and other pharmacokinetic variability: underappreciated variables affecting antiarrhythmic efficacy and safety in clinical practice.

Bioavailability and bioequivalence: an FDA regulatory overview.

Generic products of antiepileptic drugs (AEDs): is it an issue?

Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate.

Comparison of single and multiple dose pharmacokinetics using clinical bioequivalence data and Monte Carlo simulations.

The utility of cyclodextrins for enhancing oral bioavailability.

Hospitalization rates of generic metoprolol compared with the original beta-blocker in an epidemiological database study.

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