V. Shah

D. Barends, R. A. Lipper, V. Shah, 2006, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Steps for Development of a Dissolution Test for Sparingly Water-Soluble Drug Products

V. Shah, L. Ouderkirk, Carol Noory, 2000 .

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam.

J. Polli, V. Shah, J. Dressman, 2015, Journal of pharmaceutical sciences.

Transdermal Drug Delivery Systems

V. Shah, Roger L. Williams, 2014 .

Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence?

L. Lesko, A. Hussain, V. Shah, 2010, European Journal of Drug Metabolism and Pharmacokinetics.

Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products: Current Challenges and Future Prospects

V. Shah, A. Yacobi, M. Lane, 2014 .

The Bioavailability of Dermatological and Other Topically Administered Drugs

R. Guy, H. Maibach, V. Shah, 1986, Pharmaceutical Research.

Feasibility of Measuring the Bioavailability of Topical Betamethasone Dipropionate in Commercial Formulations Using Drug Content in Skin and a Skin Blanching Bioassay

V. Shah, G. Krueger, L. Pershing, 2004, Pharmaceutical Research.

Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling

L. Lesko, V. Shah, R. Williams, 1999, Clinical pharmacology and therapeutics.

Bioequivalence of Topical Dermatological Products

V. Shah, Roger L. Williams, S. Dighe, 1993 .

Assessment of Topical Corticosteroid Bioavailability In Vivo and In Vitro

V. Shah, G. Krueger, L. Pershing, 1993 .

Variability and correlation of chromameter and tape-stripping methods with the visual skin blanching assay in the quantitative assessment of topical 0.05 % betamethasone dipropionate bioavailability in humans

V. Shah, L. Pershing, L. Lambert, 1992 .

Relationship between in vivo skin blanching and in vitro release rate for betamethasone valerate creams.

V. Shah, J. Skelly, J. Elkins, 1992, Journal of pharmaceutical sciences.

Correlation between the drug penetration and the blanching effect of topically applied hydrocortisone creams in human beings.

V. Shah, H. Schaefer, D. Caron, 1990, Journal of the American Academy of Dermatology.

Cross‐Linking of Gelatin Capsules and Its Relevance to Their in vitro‐ in vivo Performance

V. Shah, T. Gold, G. Digenis, 1995 .

Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas

Erika S. Stippler, W. Hauck, R. Löbenberg, 2012, The AAPS Journal.

AAPS–FIP Summary Workshop Report: Pharmacogenetics in Individualized Medicine: Methods, Regulatory, and Clinical Applications

V. Shah, R. Mckinnon, H. Sasaki, 2009, The AAPS Journal.

Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal Consta.

Erika S. Stippler, V. Shah, D. Burgess, 2011, International journal of pharmaceutics.

Simple high-pressure liquid chromatographic determination of trisulfapyrimidines in human serum.

V. Shah, J. Jaffe, T. Goehl, 1978, Journal of pharmaceutical sciences.

Bioavailability of sulfonamide suspensions I: Dissolution profiles of sulfamethizole using paddle method.

V. Shah, J. Jaffe, T. Goehl, 1978, Journal of pharmaceutical sciences.

Evaluation of Orally Administered Highly Variable Drugs and Drug Formulations

Mario A. González, W. H. Barr, L. Benet, 1996, Pharmaceutical Research.

Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies

A Yacobi, C. T. Viswanathan, C T Viswanathan, 1991, European Journal of Drug Metabolism and Pharmacokinetics.

Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride.

D. Barends, H. Junginger, K. Midha, 2005, Journal of pharmaceutical sciences.

Bioanalytical Method Validation—A Revisit with a Decade of Progress

Vinod P. Shah, Kamal K. Midha, John W. A. Findlay, 2000, Pharmaceutical Research.

Biowaiver monographs for immediate-release solid oral dosage forms: Zidovudine (azidothymidine).

K. C. Soares, J. Polli, V. Shah, 2013, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen.

D. Barends, H. Junginger, K. Midha, 2005, Journal of pharmaceutical sciences.

AAPS-FDA Workshop White Paper: Microdialysis Principles, Application and Regulatory Perspectives

Eva Benfeldt, Vinod P. Shah, Hartmut Derendorf, 2006, Pharmaceutical Research.

Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

Vinod P. Shah, C. T. Viswanathan, Jeffrey Sailstad, 2007, The AAPS Journal.

Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies

Thomas Layloff, Vinod P. Shah, Kamal K. Midha, 1992, Pharmaceutical Research.

Biowaiver monographs for immediate release solid oral dosage forms: levofloxacin.

D. Barends, H. Junginger, S. Stavchansky, 2011, Journal of pharmaceutical sciences.

Griseofulvin levels in stratum corneum. Study after oral administration in man.

V. Shah, S. Riegelman, W. Epstein, 1972, Archives of dermatology.

Determination of griseofulvin in skin, plasma, and sweat.

V. Shah, S. Riegelman, W. Epstein, 1972, Journal of pharmaceutical sciences.

In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactants

Vinod P. Shah, Jerome P. Skelly, Richard L. Everett, 1989, Pharmaceutical Research.

Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms

Christos Reppas, Vinod P. Shah, Gordon L. Amidon, 2004, Pharmaceutical Research.

Topically applied griseofulvin in prevention and treatment of Trichophyton mentagrophytes.

V. Shah, S. Riegelman, W. Epstein, 1975, Archives of dermatology.

Electron Capture Gas Chromatographic Assay for Miconazole and Clotrimazole In Skin Samples

V. Shah, S. Riegelman, S. Wallace, 1978 .

Validation of Bioanalytical Methods

Vinod P. Shah, H. T. Karnes, H. Thomas Karnes, 1991, Pharmaceutical Research.

Role of sweat in accumulation of orally administered griseofulvin in skin.

V. Shah, S. Riegelman, W. Epstein, 1974, The Journal of clinical investigation.

Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets.

J. Polli, V. Shah, L. Augsburger, 1997, Journal of pharmaceutical sciences.

Statistical Assessment of Mean Differences between Two Dissolution Data Sets*

V. Shah, Y. Tsong, T. Hammerstrom, 1996 .

Transdermal Drug Delivery System Regulatory Issues

V. Shah, 2002 .

Topical and Transdermal Drug Products

H. Maibach, G. Flynn, V. Shah, 2010 .

Topically applied antifungal agents. Percutaneous penetration and prophylactic activity against trichophyton mentagrophytes infection.

V. Shah, S. Riegelman, S. Wallace, 1977, Archives of dermatology.

The effect of irritant dermatitis on cutaneous bioavailability of a metronidazole formulation, investigated by microdialysis and dermatopharmacokinetic method

S. Hansen, V. Shah, T. Menné, 2008, Contact dermatitis.

Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method.

S. Hansen, V. Shah, A. Vølund, 2007, The Journal of investigative dermatology.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin

J. Polli, V. Shah, J. Dressman, 2016, Journal of Pharmaceutical Sciences.

A science based approach to topical drug classification system (TCS).

V. Shah, D. Miron, A. Yacobi, 2015, International journal of pharmaceutics.

In vitro release profile of estradiol transdermal therapeutic systems.

V. Shah, J. Skelly, N. W. Tymes, 1990, Journal of pharmaceutical sciences.

Novel Metrics to Compare Dissolution Profiles

J. Polli, V. Shah, Paul R. Seo, 2002, Pharmaceutical development and technology.

Methods to Compare Dissolution Profiles*

J. Polli, V. Shah, G. S. Rekhi, 1996 .

A Standardized Mini Paddle Apparatus as an Alternative to the Standard Paddle

Sandra Klein, Vinod P. Shah, V. Shah, 2008, AAPS PharmSciTech.

Topical Drug Bioavailability, Bioequivalence, and Penetration

H. Maibach, V. Shah, J. Jenner, 2014, Springer New York.

Biowaiver monographs for immediate release solid oral dosage forms: efavirenz.

J. Polli, V. Shah, J. Dressman, 2013, Journal of pharmaceutical sciences.

Conference report: Bio-International 2005.

K. Midha, V. Shah, R. Patnaik, 2007, Journal of pharmaceutical sciences.

Factors to be considered in the evaluation of bioavailability and bioequivalence of topical formulations.

G. Flynn, V. Shah, A. Ghanem, 1992, Skin pharmacology : the official journal of the Skin Pharmacology Society.

Importance of In Vitro Drug Release

V. Shah, Roger L. Williams, 2014 .

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate.

J. Polli, A. Parr, V. Shah, 2020, Journal of pharmaceutical sciences.

MEETING REPORT: Dissolution Testing of Special Dosage Forms

Cynthia K. Brown, V. Shah, H. Möller, 1999 .

Progress in Methodologies for Evaluating Bioequivalence of Topical Formulations

V. Shah, 2001, American journal of clinical dermatology.

Scale-up of Adhesive Transdermal Drug Delivery Systems

Mario A. González, G. Flynn, A. Hussain, 1997, Pharmaceutical Research.

In Vitro Dissolution Profile Comparison—Statistics and Analysis of the Similarity Factor, f2

Yi Tsong, Vinod P. Shah, V. Shah, 1998, Pharmaceutical Research.

Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report

Cynthia K. Brown, John C. Kraemer, V. Shah, 2014, Pharmaceutical Research.

Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Dissolution Behavior of Glibenclamide

Raimar Löbenberg, Vinod P. Shah, Johannes Krämer, 2000, Pharmaceutical Research.

The Relative Bioavailability and In Vivo-In Vitro Correlations for Four Marketed Carbamazepine Tablets

L. Lesko, V. Shah, A. Straughn, 1998, Pharmaceutical Research.

In vitro dissolution of sparingly water-soluble drug dosage forms

Vinod P. Shah, Jerome P. Skelly, Richard L. Everett, 1995 .

In vitro release of phenol from ointment formulations

V. Shah, J. Zatz, J. D. Segers, 1997 .

Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products

G. Flynn, V. Shah, T. Franz, 1999, Pharmaceutical Research.

Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products.

V. Shah, L. Pershing, J. Corlett, 2003, Journal of the American Academy of Dermatology.

In vitro Release Test (IVRT): Principles and Applications.

H. Maibach, V. Shah, J. Cardot, 2022, International journal of pharmaceutics.

IV-IVC for topically applied preparations--a critical evaluation.

V. Shah, 2005, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Biowaiver monographs for immediate release solid oral dosage forms: acetazolamide.

D. Barends, H. Junginger, S. Stavchansky, 2008, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: isoniazid.

D. Barends, G. Amidon, H. Junginger, 2007, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and diclofenac potassium.

D. Barends, J. Polli, G. Amidon, 2009, Journal of pharmaceutical sciences.

Influence of higher rates of agitation on release patterns of immediate-release drug products.

V. Shah, J P Skelly, S. Dighe, 1992, Journal of pharmaceutical sciences.

fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms

Yi Tsong, Vinod P. Shah, Gur Jai Pal Singh, 1997 .

Biowaiver monographs for immediate release solid oral dosage forms: aciclovir.

D. Barends, G. Amidon, M. Bermejo, 2008, Journal of pharmaceutical sciences.

Comparison of ultraviolet and liquid chromatographic methods for dissolution testing of sodium phenytoin capsules.

V. Shah, K. E. Ogger, 1986, Journal of pharmaceutical sciences.

FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

Todd L. Cecil, Cynthia K. Brown, Horst Dieter Friedel, 2011, AAPS PharmSciTech.

Meeting Report: FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms

Cynthia K. Brown, John C. Kraemer, V. Shah, 2011 .

Drug dissolution into micellar solutions: development of a convective diffusion model and comparison to the film equilibrium model with application to surfactant-facilitated dissolution of carbamazepine.

J. Crison, G. Amidon, V. Shah, 1996, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: ciprofloxacin hydrochloride.

D. Barends, H. Junginger, S. Stavchansky, 2011, Journal of pharmaceutical sciences.

In vitro drug release measurement for topical glucocorticoid creams

V. Shah, 1993 .

GLC determination of theophylline in biological fluids.

V. Shah, S. Riegelman, V. P. Shah, 1974, Journal of pharmaceutical sciences.

Dissolution profiles and specifications for dihydroergotoxine sublingual tablets using a new in vitro method.

V. Shah, B. Cabana, J. Hunt, 1981, Journal of pharmaceutical sciences.

Bioavailability of hydrochlorothiazide from tablets and suspensions.

P. Welling, V. Shah, R. Patel, 1984, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol.

G L Amidon, D M Barends, M Olling, 2004, Journal of pharmaceutical sciences.

Thiazides XI: partitioning of chlorothiazide in red blood cells after oral administration.

V. Shah, M. Walker, B. Cabana, 1984, Biopharmaceutics & drug disposition.

Thiazides III. Evidence of dose proportionality of hydrochlorothiazide 25, 50 and 100 mg tablets.

V. Shah, B. Cabana, J. Hunt, 1983, Research communications in chemical pathology and pharmacology.

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.

J. Polli, A. Parr, V. Shah, 2017, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: quinidine sulfate.

D. Barends, J. Polli, H. Junginger, 2009, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: quinidine sulfate.

D. Barends, H. Junginger, S. Stavchansky, 2009, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol).

D. Barends, G. Amidon, H. Junginger, 2006, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: metronidazole.

D. Barends, H. Junginger, S. Stavchansky, 2011, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: lamivudine.

D. Barends, H. Junginger, S. Stavchansky, 2011, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: pyrazinamide.

D. Barends, G. Amidon, H. Junginger, 2008, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate-release solid oral dosage forms: stavudine.

D. Barends, H. Junginger, S. Stavchansky, 2012, Journal of pharmaceutical sciences.

Human Intestinal Permeability of Piroxicam, Propranolol, Phenylalanine, and PEG 400 Determined by Jejunal Perfusion

G. Amidon, L. Lesko, H. Lennernäs, 1997, Pharmaceutical Research.

Effect of dietary fat content on the bioavailability of a sustained release quinidine gluconate tablet.

I. L. Honigberg, V. Shah, J. Gallo, 1990, Biopharmaceutics & drug disposition.

Biowaiver monographs for immediate release solid oral dosage forms: rifampicin.

D. Barends, H. Junginger, S. Stavchansky, 2009, Journal of pharmaceutical sciences.

Thiazides. VIII: Dissolution survey of marketed hydrochlorothiazide tablets.

V. Shah, L. Augsburger, R. Shangraw, 1983, Journal of pharmaceutical sciences.

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

Jack A. Cook, Vinod P. Shah, Lawrence X. Yu, 2008, The AAPS Journal.

Determination of the formation of the stratum corneum reservoir for two different corticosteroid formulations using tape stripping combined with UV/VIS spectroscopy

V. Shah, W. Sterry, M. Linscheid, 2004, Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG.

Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride.

D. Barends, J. Polli, H. Junginger, 2011, Journal of pharmaceutical sciences.

Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies

Binodh DeSilva, David Lansky, Russell Weiner, 2005, Pharmaceutical Research.

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride.

J. Polli, A. Parr, V. Shah, 2018, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate-release solid oral dosage forms: primaquine phosphate.

D. Barends, J. Polli, V. Shah, 2012, Journal of pharmaceutical sciences.

Progressive applications of dissolution, its impact, and implications in the pharmaceutical world.

V. Shah, 2013, Journal of Pharmacy and Science.

Biowaiver monographs for immediate-release solid oral dosage forms: ketoprofen.

D. Barends, J. Polli, V. Shah, 2012, Journal of pharmaceutical sciences.

Rethinking the Use of Water as a Dissolution Medium

V. Shah, L. Ouderkirk, Carol Noory, 1999 .

The Use of BDDCS in Classifying the Permeability of Marketed Drugs

Vinod P. Shah, Lawrence X. Yu, James E. Polli, 2008, Pharmaceutical Research.

in Vitro Dissolution Profile Comparison and IVIVR

V. Shah, Y. Tsong, Pradeep M. Sathe, 1997 .

G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS

G. Amidon, V. Shah, 2014, The AAPS Journal.

Biowaiver monographs for immediate release solid oral dosage forms: ranitidine hydrochloride.

D M Barends, H E Junginger, D. Barends, 2005, Journal of pharmaceutical sciences.

Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm

Matthew Howard, Bruce Thompson, Vinod P. Shah, 2014, AAPS PharmSciTech.

Bioavailability and dissolution behavior of trisulfapyrimidine suspensions.

V. Shah, J. Jaffe, H. Barry, 1979, Journal of Pharmacy and Science.

ROLE OF IN VITRO RELEASE MEASUREMENT IN SEMISOLID DOSAGE FORMS

V. Shah, R. Williams, J. Elkins, 1999 .

From Drug Delivery Systems to Drug Release, Dissolution, IVIVC, BCS, BDDCS, Bioequivalence and Biowaivers

V. Shah, V. Karalis, P. Macheras, 2010, Pharmaceutical Research.

Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability

A. Peer, V. Shah, V. Karalis, 2008, Pharmaceutical Research.

Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate.

Naseem A. Charoo, J. Polli, V. Shah, 2014, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: ethambutol dihydrochloride.

D. Barends, G. Amidon, H. Junginger, 2008, Journal of pharmaceutical sciences.

Microultrafiltration technique for drug-protein binding determination in plasma.

V. Shah, S. Riegelman, S. Wallace, 1974, Journal of pharmaceutical sciences.

DISSOLUTION PROFILES OF RESIN-BASED ORAL SUSPENSIONS

V. Shah, J. Skelly, Carol Noory, 1991 .

The Effect of Gelatin Cross-Linking on the Bioequivalence of Hard and Soft Gelatin Acetaminophen Capsules

A. Hussain, V. Shah, A. Straughn, 2000, Pharmaceutical Research.

Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development

Lewis B. Sheiner, Vinod P. Shah, C. T. Viswanathan, 1992, Pharmaceutical Research.

Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development

C. T. Viswanathan, Avraham Yacobi, Gerhard Levy, 1992, Clinical pharmacology and therapeutics.

The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation

Vinod P. Shah, V. Shah, 2007, The AAPS Journal.

Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products.

V. Shah, I. Antal, S. Stegemann, 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

GLC analysis of acetazolamide in blood, plasma, and saliva following oral administration to normal subjects.

V. Shah, S. Riegelman, S. Wallace, 1977, Journal of pharmaceutical sciences.

Thiazides XII: A Simple HPLC Method for Determination of Thiazides in Urine

V. Shah, V. K. Prasad, Jennifer Lee, 1982 .

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril.

J. Polli, R. Löbenberg, I. Kanfer, 2017, Journal of pharmaceutical sciences.

Dissolution Profile Comparison Using Similarity Factor, f2

Yi Tsong, Vinod P. Shah, V. Shah, 1999 .

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride.

J. Polli, A. Parr, V. Shah, 2021, Journal of pharmaceutical sciences.

Commonality between BCS and TCS.

V. Shah, D. Miron, A. Yacobi, 2016, International journal of pharmaceutics.

G. Amidon, V. Shah, 2014, The AAPS Journal.

Tackling the challenges of nanomedicines: are we ready?

V. Shah, G. Stemer, S. Mühlebach, 2021, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

Release of Hydrocortisone from a Cream Matrix: Dependency of Release on Suspension Concentration and Measurement of Solubility and Diffusivity

G. Flynn, V. Shah, L. Abriola, 2001, Pharmaceutical development and technology (Print).

Are European marketed acyclovir 5% cream products similar? Comparison with EU and US reference product

A. Minea, V. Shah, J. Cardot, 2021, Drug development and industrial pharmacy.

Principles and criteria in the development and optimization of topical therapeutic products.

G. Flynn, V. Shah, W. Higuchi, 1992, Pharmaceutical research.

Principles and criteria in the development and optimization of topical therapeutic products.

G. Flynn, V. Shah, W. Higuchi, 1992, Journal of pharmaceutical sciences.

The Role of Dissolution Testing in the Regulation of Pharmaceuticals: The FDA Perspective

Vinod P. Shah, V. Shah, 2005 .

Regulatory Aspects Pertinent to the Development of Transdermal Drug Delivery Systems

V. Shah, J. Skelly, 1986 .

Beat Flühmann, Imre Klebovich, Stefan Mühlebach, 2015, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

Arnold G. Vulto, Jon S. B. de Vlieger, Beat Flühmann, 2013 .

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

V. Shah, D. Crommelin, S. Stegemann, 2013, The AAPS Journal.

Different Pharmaceutical Products Need Similar Terminology

V. Shah, D. Crommelin, H. Schellekens, 2013, The AAPS Journal.

Application of Flow Programming in the Analysis of Drugs and Their Metabolites in Biological Fluids

V. Shah, V. K. Prasad, M. A. Walker, 1983 .

Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology

S. Hansen, V. Shah, J. Sonne, 2010, Skin Pharmacology and Physiology.

Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

H. Maibach, I. Kanfer, V. Shah, 2014, Pharmaceutical Research.

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate.

J. Polli, A. Parr, V. Shah, 2017, Journal of pharmaceutical sciences.

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine.

J. Polli, V. Shah, J. Dressman, 2015, Journal of pharmaceutical sciences.

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.

J. Polli, A. Parr, V. Shah, 2019, Journal of pharmaceutical sciences.

In Vitro Release from Semisolid Dosage Forms‚ÄîWhat Is Its Value?

V. Shah, 2005 .

In Vitro Release of Hydrocortisone from Topical Preparations and Automated Procedure

Vinod P. Shah, Jerome P. Skelly, V. Shah, 2004, Pharmaceutical Research.

Analysis of Thyroidal Amino Acids in Pharmaceutical Preparations. I - Reverse Phase High Pressure Liquid Chromatography Analysis of Sodium Liothyronine from Tablets

V. Shah, R. Rapaka, V. K. Prasad, 1979 .

Biowaiver monographs for immediate release solid oral dosage forms: metoclopramide hydrochloride.

D. Barends, H. Junginger, S. Stavchansky, 2008, Journal of pharmaceutical sciences.

Bioequivalency and dose proportionality of three tableted promethazine products.

I. L. Honigberg, V. Shah, J. Kotzan, 1986, Biopharmaceutics & drug disposition.

Three-Stage Sequential Statistical Dissolution Testing Rules

Meiyu Shen, Yi Tsong, V. Shah, 2004, Journal of biopharmaceutical statistics.

Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles

Mario A. González, V. Shah, P. Basu, 2012, AAPS PharmSciTech.

Biowaiver monographs for immediate release solid oral dosage forms: prednisone.

D. Barends, H. Junginger, S. Stavchansky, 2007, Journal of pharmaceutical sciences.

Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years.

Malcolm Rowland, Christian R Noe, C. Noe, 2012, Journal of pharmaceutical sciences.

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine dihydrochloride.

Naseem A. Charoo, J. Polli, A. Parr, 2022, Journal of pharmaceutical sciences.

Impact of adult atopic dermatitis on topical drug penetration: assessment by cutaneous microdialysis and tape stripping.

S. Hansen, V. Shah, T. Menné, 2009, Acta Dermato-Venereologica.

Challenges in evaluating bioequivalence of dermatological drug products.

V. Shah, 1995, Current problems in dermatology.

Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

H. Maibach, I. Kanfer, V. Shah, 2014, Pharmaceutical Research.

Current Challenges and Future Regulatory Directions in In Vitro Dissolution

L. Lesko, V. Shah, 1995 .

Evaluation of the absorption from 15 commercial theophylline products indicating deficiencies in currently applied bioavailability criteria

V. Shah, L. Sansom, J. Powell, 1980, Journal of Pharmacokinetics and Biopharmaceutics.

FIP/WHO/CHINA Bioequivalence and Hands-on-Dissolution Workshop Report Beijing, China, April 12–13, 2004 Shanghai, China, April 15–16, 2004

V. Shah, 2004 .

Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report

Cynthia K. Brown, John C. Kraemer, V. Shah, 2012, Pharmaceutical Research.

Report of the Workshop on In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms

J. E. Carter, W. H. Barr, G. Amidon, 1990 .

Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride.

D. Barends, H. Junginger, S. Stavchansky, 2011, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: amitriptyline hydrochloride.

D. Barends, G. Amidon, V. Shah, 2006, Journal of pharmaceutical sciences.

Dissolution: a Continuing Perspective

V. Shah, J. Dressman, T. Foster, 2004 .

The Bioinequivalence of Carbamazepine Tablets with a History of Clinical Failures

Vinod P. Shah, George C. Wood, V. Shah, 1992, Pharmaceutical Research.

flP Guidelines for Dissolution Testing of Solid Oral Products Joint Report of the Section for O"icial laboratories and Medicines Control Services and the Section of Industrial Pharmacists of the FIP

L. Lesko, V. Shah, J. Dressman, 1997 .

Phenytoin II: in vitro-in vivo bioequivalence standard for 100-mg phenytoin sodium capsules.

V. Shah, V K Prasad, J P Skelly, 1983, Journal of pharmaceutical sciences.

Thiazides IV: Comparison of dissolution with bioavailability of chlorothiazide tablets.

V. Shah, B. Cabana, V. K. Prasad, 1982, Journal of pharmaceutical sciences.

TOPICAL CORTICOSTEROIDS: QUALITY CONTROL CONSIDERATIONS

V. Shah, 1992, International journal of dermatology.

Biowaiver monographs for immediate release solid oral dosage forms: piroxicam.

D. Barends, J. Polli, V. Shah, 2014, Journal of pharmaceutical sciences.

Non-biological complex drugs (NBCDs) and their follow-on versions: time for an editorial section

Gerrit Borchard, Vinod P. Shah, Jon S. B. de Vlieger, 2015 .

Workshop on the challenges in substitution of nonbiological complex drugs.

V. Shah, A. Vulto, S. Mühlebach, 2013, American Journal of Health-System Pharmacy.

How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider

Vinod P. Shah, Rogério Gaspar, Huub Schellekens, 2013, The AAPS Journal.

Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.

Lawrence X. Yu, H. Winkle, S. Preskorn, 2010, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

FIP Guidelines for Dissolution Testing of Solid Oral Products.

Cynthia K. Brown, John C. Kraemer, V. Shah, 2018, Journal of pharmaceutical sciences.

Topical 0.050% Betamethasone Dipropionate: Pharmacokinetic and Pharmacodynamic Dose-Response Studies in Humans

V. Shah, L. Pershing, Roger L. Williams, 1994 .

Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate.

D. Barends, G. Amidon, H. Junginger, 2010, Journal of pharmaceutical sciences.

Influence of dioctyl sodium sulfosuccinate on the absorption of tetracycline.

V. Shah, J. Hunt, W. Fairweather, 1986, Biopharmaceutics & drug disposition.

In vivo percutaneous penetration / absorption Sponsored by the American Association of Pharmaceutical Scientists

R. Guy, H. Maibach, G. Flynn, 2002 .

Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report.

Lawrence X. Yu, H. Winkle, S. Preskorn, 2010, Clinical therapeutics.

FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

Vinod P. Shah, Ajaz S. Hussain, William R. Gillespie, 1997 .

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine.

J. Polli, A. Parr, V. Shah, 2021, Journal of pharmaceutical sciences.

In-Vitro Dissolution Profile Comparison: Statistics and Analysis, Model Dependent Approach

Yi Tsong, Vinod P. Shah, V. Shah, 1996, Pharmaceutical Research.

Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report

Cynthia K. Brown, John C. Kraemer, V. Shah, 2014, Pharmaceutical Research.

Biowaiver monographs for immediate-release solid oral dosage forms: codeine phosphate.

J. Polli, G. Amidon, V. Shah, 2014, Journal of pharmaceutical sciences.

Biowaiver monograph for immediate-release solid oral dosage forms: acetylsalicylic acid.

D. Barends, J. Polli, V. Shah, 2012, Journal of pharmaceutical sciences.

PQRI Workshop Report: Application of IVIVC in Formulation Development

Anthony J. DeStefano, Sandra Suarez-Sharp, Maziar Kakhi, 2014 .

Progressively Reducing Regulatory Burden

V. Shah, Roger L. Williams, Srini Srinivasan, 2014, The AAPS Journal.

Bioequivalence of Methylphenidate Immediate-Release Tablets Using a Replicated Study Design to Characterize Intrasubject Variability

V. Shah, A. Straughn, M. Meyer, 2000, Pharmaceutical Research.

In Vitro and in Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms

J. E. Carter, Vinod P. Shah, Avraham Yacobi, 2004, Pharmaceutical Research.

Skin penetration enhancers: scientific perspectives

V. Shah, 1994 .

In vitro assessment of skin permeation from a transdermal system for the delivery of oestradiol

J. Hadgraft, V. Shah, K. Brain, 1993 .

In-vitro release from corticosteroid ointments.

V. Shah, V P Shah, J S Elkins, 1995, Journal of pharmaceutical sciences.

In Vitro Release Profiles of Clonidine Transdermal Therapeutic Systems and Scopolamine Transdermal Patches

V. Shah, J. Skelly, N. W. Tymes, 1989, Pharmaceutical Research.

Variability in cimetidine absorption and plasma double peaks following oral administration in the fasted state in humans: correlation with antral gastric motility.

Lawrence J Lesko, Ryuzo Yamamoto, Gordon L Amidon, 2002, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

Analytical Methods used in Bioavailability Studies: A Regulators Viewpoint

Vinod P. Shah, V. Shah, 1987 .

In vitro dissolution profile of transdermal nitroglycerin patches using paddle method

V. Shah, J. Skelly, L. A. Yamamoto, 1986 .

Comparative in vitro release profiles of marketed nitroglycerin patches by different dissolution methods

V. Shah, J. Skelly, N. W. Tymes, 1988 .

Bioavailability and Bioequivalence of Transdermal Drug Delivery Systems

V. Shah, T. Ludden, J. Skelly, 1993 .

Practical Considerations in Developing a Quality Control (In Vitro Release) Procedure for Topical Drug Products

V. Shah, J. Skelly, 1993 .

Performance Test for Parenteral Dosage Forms

V. Shah, James Demuth, D. Hunt, 2015 .

Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report

Lawrence X. Yu, H. Winkle, S. Preskorn, 2010, The AAPS Journal.

Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.

Lawrence X. Yu, V. Shah, J. Dressman, 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Variability in the elimination of trisulfapyrimidines in man.

V. Shah, J. Jaffe, L. Mathur, 1983, Biopharmaceutics & drug disposition.

Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials”

Rachael M. Crist, V. Shah, D. Crommelin, 2019, The AAPS Journal.

Comparison of plasma and urine analyses for thiazides in bioavailability/bioequivalence study.

V. Shah, B. Cabana, J. Hunt, 1981, Journal of pharmaceutical sciences.

The Inhalation Ad Hoc Advisory Panel for the USP Performance Tests of Inhalation Dosage Forms

V. Shah, M. Sakagami, J. Veranth, 2008 .

Skin penetration enhancement. Clinical pharmacological and regulatory considerations

V. Shah, C. Peck, R. Williams, 1993 .

In vitro and in vivo evaluation of three metronidazole topical products

V. Shah, D. Miron, V. Voicu, 2014, Pharmaceutical development and technology.

Interference with measurements of certain drugs in plasma by a plasticizer in vacutainer tubes.

V. Shah, B. Cabana, J. Skelly, 1982, Clinical chemistry.

Drug assay interference caused by plasticizer in Vacutainers.

V. Shah, B. Cabana, J. Skelly, 1982, American journal of hospital pharmacy.

Phenytoin I: in vitro-in vivo correlation for 100-mg phenytoin sodium capsules.

M C Meyer, V. Shah, M. Meyer, 1983, Journal of pharmaceutical sciences.

Evaluation of basket and paddle dissolution methods using different performance standards.

V. Shah, B. Cabana, J. Hunt, 1983, Journal of pharmaceutical sciences.

Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach

Thomas Layloff, Stephen Lowes, Surendra K. Bansal, 2004, AAPS PharmSciTech.

Dissolution: A Quality Control Test vs. A Bioequivalence Test

Vinod P. Shah, V. Shah, 2001 .

Table1. EffectofDrugs ontheDetermination ofProteinConcentration In UrinebyThreeDifferent Methods

V. Shah, B. Cabana, J. Skelly, 1982 .

Lack of In Vivo/In Vitro Correlations for 50 mg and 250 mg Primidone Tablets

L. Lesko, V. Shah, A. Straughn, 1998, Pharmaceutical Research.

Biowaiver monographs for immediate-release solid oral dosage forms: quinine sulfate.

D. Barends, J. Polli, V. Shah, 2012, Journal of pharmaceutical sciences.

Bioequivalence of Topical Dermatological Dosage Forms – Methods of Evaluation of Bioequivalence

Howard I. Maibach, Charles Bon, Vinod P. Shah, 1998, Skin Pharmacology and Physiology.

Biowaiver monographs for immediate release solid oral dosage forms: amodiaquine hydrochloride.

D. Barends, J. Polli, V. Shah, 2012, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: ciprofloxacin hydrochloride.

D. Barends, H. Junginger, S. Stavchansky, 2011, Journal of pharmaceutical sciences.

Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development.

G Levy, C. T. Viswanathan, C C Peck, 1992, Journal of clinical pharmacology.

Principles and Criteria in the Development and Optimization of Topical Therapeutic Products

G. Flynn, V. Shah, W. Higuchi, 1992, Pharmaceutical Research.

Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas

Walter W. Hauck, Erika S. Stippler, R. Löbenberg, 2012, The AAPS Journal.

Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol).

D. Barends, G. Amidon, H. Junginger, 2006, Journal of pharmaceutical sciences.

D. Barends, G. Amidon, H. Junginger, 2004, Journal of pharmaceutical sciences.

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.

J. Polli, A. Parr, V. Shah, 2017, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: furosemide.

D. Barends, H. Junginger, S. Stavchansky, 2010, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate release solid oral dosage forms: metronidazole.

D. Barends, H. Junginger, S. Stavchansky, 2011, Journal of pharmaceutical sciences.

Biowaiver monographs for immediate-release solid oral dosage forms: Zidovudine (azidothymidine).

K. C. Soares, J. Polli, V. Shah, 2013, Journal of pharmaceutical sciences.

Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products.

V. Shah, I. Antal, S. Stegemann, 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays

C. T. Viswanathan, Patrick G. Swann, V. Shah, 2007, The AAPS Journal.

Historical perspective on the development and evolution of bioanalytical guidance and technology.

V. Shah, Surendra Bansal, 2011, Bioanalysis.

Dissolution/In Vitro Release Testing of Special Dosage Forms*

Cynthia K. Brown, Vinod P. Shah, V. Shah, 2002 .

Report of the Workshop on Controlled-Release Dosage Forms: Issues and Controversies

Vinod P. Shah, Avraham Yacobi, Jerome P. Skelly, 1987, Pharmaceutical Research.

Bioavailability of hydrocortisone from commercial 20-mg tablets.

P. Welling, V. Shah, R. Patel, 1984, Journal of pharmaceutical sciences.

In vivo-in vitro correlations for trisulfapyrimidine suspensions.

V. Shah, J. Jaffe, L. Mathur, 1983, Journal of pharmaceutical sciences.