Converging Generic Drug Product Development: Bioequivalence Design and Reference Product Selection

Charoo, Naseem A.

doi:10.1007/s40262-020-00912-z

Cited by 5 publications

(3 citation statements)

References 9 publications

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“…The 90% confidence intervals of the ratios for the area under the drug-concentration time curve and maximum plasma concentration of generic to branded products must fall within an 80% to 125% range. The fact that confidence intervals are required to be in this range minimizes the potential differences between these products 8 . In the majority of cases, these disparities are relatively small leading to minimal variation in therapeutic efficacy 9 .…”

Section: Discussionmentioning

confidence: 99%

“…The fact that confidence intervals are required to be in this range minimizes the potential differences between these products. 8 In the majority of cases, these disparities are relatively small leading to minimal variation in therapeutic efficacy. 9 Nonetheless, generic products that have more or less active ingredient than their corresponding branded medications can potentially lead to changes in efficacy.…”

Section: Discussionmentioning

confidence: 99%

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Decrease in Antidepressant Efficacy After Change in Generic Formulation

Constantino

2021

J Clin Psychopharmacol

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Decrease in Antidepressant Efficacy After Change in Generic Formulation

Constantino

2021

J Clin Psychopharmacol

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“…In bio-equivalence studies, many issues are related to reference products and their availability [32]. In assessing these results, there should be a novel assessment [33].…”

Section: Risk Assessmentmentioning

confidence: 99%

Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration

Reddy

Ganesh

Babu

et al. 2022

Acta Marisiensis - Seria Medica

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Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic drugs, which provide a 180-day monopoly market for first generic applicants in the United States of America. The aim of the present study is to find the root cause of failures in developing and filing the first generic drugs under these exclusivities and to compare both the exclusivities to find the merits and demerits. Methods: We used descriptive statistics for data analysis of both the exclusivities and Risk assessment was conducted on 14 industries to find the root cause of failures in every stage of the approval procedure by FMECA (Failure mode, Effects and Criticality Analysis). Results: We found 44% of rejections in competitive generic therapy drugs and 30% of rejections in patent challenge exclusivity drugs. The risk analysis conducted on failures found that, in drug selection, 6% of failures are occurred due to rare diseases. In drug development, 9% of failures are occurred due to formulation failures. In pre-approval, 10% of failures are occurred due to secondary patents. In post-approval, 6% of failures are occurred due to product changes after approval. Conclusion: We hope this study can give an idea for small and medium companies in developing countries for the early development of generic drugs for life-threatening diseases.

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