Advances in in-vitro bioequivalence testing methods for complex ophthalmic generic products

Renukuntla, Jwala; Palakurthi, Sushesh Srivatsa; Bolla, Pradeep Kumar; Clark, Bradley A.; Boddu, Sai H. S.; Manda, Prashanth; Sockwell, Samuel; Charbe, Nitin; Palakurthi, Srinath

doi:10.1016/j.ijpharm.2022.122209

Cited by 5 publications

(2 citation statements)

References 61 publications

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“…Oftentimes, these discussions focus on the impact of one or more guideline(s) on a specific aspect of a process [11,12] or of the medical product [13]. Infrequently, there is a request for more guidance [14].…”

Section: Regulation As the Number Of Fda-issued Guidelinesmentioning

confidence: 99%

The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

Daizadeh

2023

Pharm Res

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Purpose Is the complexity of medical product (medicines and medical devices) regulation impacting innovation in the US? If so, how? Methods Here, this question is investigated as follows: Various novel proxy metrics of regulation (FDA-issued guidelines) and innovation (corresponding FDA-registrations) from 1976–2020 are used to determine interdependence, a concept relying on strong correlation and reciprocal causality (estimated via variable lag transfer entropy and wavelet coherence). Results Based on the observed interdependence, a mapping of regulation onto innovation is conducted and finds that regulation seems to accelerate then supports innovation until on or around 2015; at which time, an inverted U-curve emerged. Conclusions If empirically evidentiary, an important innovation-regulation nexus in the US has been reached; and, as such, stakeholders should (re)consider the complexity of the regulatory landscape to enhance US medical product innovation. Study limitations, extensions, and further thoughts complete this investigation. Graphical abstract Supplementary Information The online version contains supplementary material available at 10.1007/s11095-023-03512-1.

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Section: Regulation As the Number Of Fda-issued Guidelinesmentioning

confidence: 99%

The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

Daizadeh

2023

Pharm Res

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“…Furthermore, analytical method development and characterization of the complex lipid based drug delivery system is one major challenge the current pharmaceutical companies are facing. In-vitro bioequivalence testing and evaluation of new methods for dissolution and other physical and chemical attributes needs to be considered while developing the lipid based formulations 55,56 .…”

Section: Formulation Problemsmentioning

confidence: 99%

An overview of lipid based vesicular systems: stability and regulatory considerations

BOGGULA¹,

BAKSHI²,

PEDDAPALLI³

2022

GSC Biol. Pharm. Sci.

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Lipid based drug delivery systems are used to encapsulate the active substance within or interior space of the lipid bilayer. The lipid-based drug products are designed to improve the stability in-vivo and pharmacokinetics behavior of active substances. However, understanding of the factors that affect the stability is critical for rationale development of lipid based drug delivery systems with desired pharmacokinetics and bio-distribution. Lyophilization is one primary approach to improve the stability of lipid based systems. The article presents an overview of the characteristics of the lipid based drug delivery systems as drug carriers, particularly in relation to stability, regulatory considerations. Further, the present review emphasizes the formulation problems and marketed formulation of lipid-based systems.

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Development and Validation of Particle Size Measurement for Mesalamine Nanocrystals Using Dynamic Light Scattering and Microscopic Techniques

Kunjir,

Pathare,

Sharma

et al. 2024

BioNanoSci.

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Advances in in-vitro bioequivalence testing methods for complex ophthalmic generic products

Cited by 5 publications

References 61 publications

The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

The Impact of US Medical Product Regulatory Complexity on Innovation: Preliminary Evidence of Interdependence, Early Acceleration, and Subsequent Inversion

An overview of lipid based vesicular systems: stability and regulatory considerations

Development and Validation of Particle Size Measurement for Mesalamine Nanocrystals Using Dynamic Light Scattering and Microscopic Techniques

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