FDA Critical Path Initiatives: Opportunities for Generic Drug Development

Lionberger, Robert

doi:10.1208/s12248-008-9010-2

Cited by 98 publications

(85 citation statements)

References 32 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The draft guidance was subsequently withdrawn by the FDA [131] , and the current determination of BE relies on comparative clinical trials between the generic drug and the innovator drug. As clinical trials often require several hundreds of participants, this is therefore a very time-consuming and expensive procedure [1,132] .…”

Section: Bioequivalencementioning

confidence: 99%

Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

Holmgaard

Nielsen

Benfeldt

2010

Skin Pharmacol Physiol

View full text Add to dashboard Cite

Microdialysis (MD) in the skin is a unique technique for in vivo sampling of topically as well as systemically administered drugs at the site of action, e.g. sampling the unbound tissue concentrations in the dermis and subcutaneous tissue. MD as a research method has undergone significant development, improvement and validation during the last decade and has proved to be a versatile, safe and valuable tool for pharmacokinetic and pharmacodynamic studies. This review gives an overview of the current state and future perspectives of dermal MD sampling. Methodological issues such as choice of instrumentation, calibration and experimental procedures are discussed along with the analytical considerations necessary for successful sampling. Clinical MD studies in the skin are reviewed with emphasis on pharmacokinetic studies of topically applied drugs with or without impairment of skin barrier function by skin disease or barrier perturbation. A comparison between MD and other tissue sampling techniques reveals the advantages and limitations of the method. Subsequently, an in-depth discussion of the application of MD for the evaluation of bioavailability and bioequivalence of topical formulations is concluded by the current regulatory point of view. The future perspective includes further expansion and validation of the use of MD in the experimental and clinical setting as well as in the optimization of the method for regulatory purposes, i.e. the commercialization of bioequivalent, generic drug products.

show abstract

Section: Bioequivalencementioning

confidence: 99%

Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

Holmgaard

Nielsen

Benfeldt

2010

Skin Pharmacol Physiol

View full text Add to dashboard Cite

show abstract

“…The Critical Path Initiative aims to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product (3). A Critical Path Opportunities for Generic Drugs document was recently released (14,15). Bioequivalence plays an important role in this process of developing medications.…”

Section: Fda and International Initiativesmentioning

confidence: 99%

Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

Polli

Abrahamsson

et al. 2008

AAPS J

View full text Add to dashboard Cite

Abstract. The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

show abstract

“…A reversephase column (ZorbaxODS, 4 ± 6 mm, 25 cm 64.6 mm i.d; Dupont de Nemours, Wilmington, DE, USA) was used. [16] …”

Section: Methodsmentioning

confidence: 99%

Untitled

Kumaravelrajan¹

2017

AJP

View full text Add to dashboard Cite

Context: The approach for improving transdermal drug delivery is a technique called iontophoresis, a promising technology that has already received regulatory approval. Aims: The aim of the present investigation was to develop acyclovir (ACV) gel, which deliver drug through iontophoresis. Formulation variable was drug loading, current density, and hydrogen-ion concentration (pH). Factorial design was used to study the above variable with drug release at T95% as the response variable. Settings and Design: 2 3 factorial design was used to study the effect of pH, drug loading, and current density as independent variables, to T 95 % of drug release as dependent variables. Materials and Methods: The current settings were maintained at 0.5 mA. The silver wire was connected as anode at one side and silver chloride as cathode at other side. The resistor was fixed to control the flow of current from the equipment. ACV gel was prepared using Carbopol 934P. Ex vivo permeation study was conducted for 6 h in Franz diffusion cell using rat skin. Optimized formulation was analyzed for viscosity, flux, and in vivo animal study. Statistical Analysis Used: Numerical optimization carried out to find out the constrain variables. Contour plot and response surface were also studied for optimized one. Results: Two factorial interaction of independent variable with respect to dependent variable was analyzed by the kinetics of drug release. It was found that the drug release was controlled up to 6 h when variables used as pH 7.4, current input 0.5 mA, and drug loading 5% in the formulation. The Cmax and Tmax of in vivo study revealed 190 ng/ml at 6 h. Conclusions: It was found that the effectiveness of iontophoretic delivery from gel was largely affected by polarity and current density than drug loading. The optimized formulation gave desired release profile up to 6 h. Drug release kinetics seemed to be Korsmeyer-Peppas model (n = 0.875). Further in vivo study in animal model revealed the Cmax and Tmax reached the predicted time of delivery of drug without fluctuation in the plasma level.

show abstract

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

Cited by 98 publications

References 32 publications

Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

Microdialysis Sampling for Investigations of Bioavailability and Bioequivalence of Topically Administered Drugs: Current State and Future Perspectives

Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

Untitled

Contact Info

Product

Resources

About