Results 1 to 10 of about 351,529 (205)
Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development [PDF]
Clinical and Translational Science, 2023 Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for ...
Joseph Kotsybar +3 more
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Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report [PDF]
CPT: Pharmacometrics & Systems Pharmacology, 2023 For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tissues at the ...
Ming‐Liang Tan +8 more
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Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs [PDF]
Pharmaceutics, 2023 One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and ...
Ping Ren +8 more
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Predictive Analysis for First Submission of Generic Drug Application for Orphan Drug Products Using Random Survival Forest [PDF]
Clinical and Translational ScienceRare diseases affect a small population of patients, resulting in low incentives for developing orphan drug products (ODPs). The United States Congress passed the Orphan Drug Act of 1983 to incentivize pharmaceutical manufacturers to develop drugs to ...
Robert Hopefl +6 more
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CPT: Pharmacometrics & Systems Pharmacology, 2022 The coronavirus disease 2019 (COVID‐19) has presented unprecedented challenges to the generic drug development, including interruptions in bioequivalence (BE) studies.
Yuqing Gong +12 more
doaj +1 more source
Clinical and Translational Science, 2021 This study assessed the impact of product particle sizes (fine: 106–500 µm; coarse: 500–1000 µm) on oxycodone pharmacokinetics (PK) following nasal insufflation of milled oxycodone extended‐release (ER) abuse‐deterrent (AD) tablets using immediate ...
Saeid Raofi +11 more
doaj +1 more source
Heterogeneous treatment effect analysis based on machine‐learning methodology
CPT: Pharmacometrics & Systems Pharmacology, 2021 Heterogeneous treatment effect (HTE) analysis focuses on examining varying treatment effects for individuals or subgroups in a population. For example, an HTE‐informed understanding can critically guide physicians to individualize the medical treatment ...
Xiajing Gong +3 more
doaj +1 more source
Pharmaceutics, 2022 Dry powder inhalers (DPIs) are drug–device combination products where the complexity of the formulation, its interaction with the device, and input from users play important roles in the drug delivery.
Abhinav Ram Mohan +7 more
doaj +1 more source
Authorized Generic Entry prior to Patent Expiry: Reassessing Incentives for Independent Generic Entry [PDF]
, 2010 Patent holders frequently attempt to mitigate the loss of monopoly power by authorizing generic entry prior to patent expiry (early entry). Competition in off-patent pharmaceutical markets may be adversely affected if early entry substantially impairs ...
Appelt, Silvia
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CPT: Pharmacometrics & Systems Pharmacology, 2023 This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day 2 of the workshop titled “Regulatory
Abdullah Al Shoyaib +10 more
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