Vinod P. Shah
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Chemistry
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(Suggest an Edit or Addition)Vinod P. Shah's Published Works
Number of citations in a given year to any of this author's works
Total number of citations to an author for the works they published in a given year. This highlights publication of the most important work(s) by the author
Published Works
- A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability (1995) (4860)
- Bioanalytical Method Validation—A Revisit with a Decade of Progress (2000) (1606)
- Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies (1992) (1065)
- Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms (2004) (1047)
- Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays (2007) (823)
- Molecular properties of WHO essential drugs and provisional biopharmaceutical classification. (2004) (789)
- In Vitro Dissolution Profile Comparison—Statistics and Analysis of the Similarity Factor, f2 (1998) (661)
- Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions (2002) (578)
- Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays (2007) (432)
- FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms (2008) (376)
- FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms (2008) (376)
- Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets. (1997) (328)
- Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies (1991) (250)
- Cross-linking of gelatin capsules and its relevance to their in vitro-in vivo performance. (1994) (247)
- Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. (2005) (228)
- Bioavailability and Bioequivalence: An FDA Regulatory Overview (2001) (193)
- Validation of Bioanalytical Methods (1991) (184)
- AAPS‐FDA Workshop White Paper: Microdialysis Principles, Application, and Regulatory Perspectives (2007) (184)
- AAPS-FDA Workshop White Paper: Microdialysis Principles, Application and Regulatory Perspectives (2006) (165)
- Biowaiver monographs for immediate release solid oral dosage forms: diclofenac sodium and diclofenac potassium. (2009) (165)
- Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol. (2004) (163)
- Topical and Transdermal Drug Products (2010) (161)
- Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol). (2006) (160)
- Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development (1992) (156)
- Bioequivalence of Topical Dermatological Dosage Forms-Methods of Evaluation of Bioequivalence (1998) (153)
- Biowaiver monographs for immediate release solid oral dosage forms: isoniazid. (2007) (150)
- In Vitro Dissolution Profile of Water-Insoluble Drug Dosage Forms in the Presence of Surfactants (1989) (138)
- The Bioinequivalence of Carbamazepine Tablets with a History of Clinical Failures (1992) (134)
- Biowaiver monographs for immediate release solid oral dosage forms: furosemide. (2010) (131)
- The Use of BDDCS in Classifying the Permeability of Marketed Drugs (2008) (130)
- The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical methods validation (2007) (129)
- Determination of in vitro drug release from hydrocortisone creams (1989) (126)
- In-Vitro Dissolution Profile Comparison: Statistics and Analysis, Model Dependent Approach (1996) (120)
- Topical Drug Bioavailability, Bioequivalence, and Penetration (1993) (114)
- FIP/AAPS Guidelines for Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms* (2003) (114)
- Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Dissolution Behavior of Glibenclamide (2000) (112)
- FDA and AAPS Report of the Workshop on Principles and Practices of In Vitro Percutaneous Penetration Studies: Relevance to Bioavailability and Bioequivalence (1987) (102)
- FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms (2011) (100)
- Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies (2005) (99)
- Correlation of the Local Distribution of Topically Applied Substances Inside the Stratum corneum Determined by Tape-Stripping to Differences in Bioavailability (2001) (98)
- Biowaiver monographs for immediate release solid oral dosage forms: ciprofloxacin hydrochloride. (2011) (96)
- Biowaiver monographs for immediate release solid oral dosage forms: aciclovir. (2008) (95)
- How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider (2013) (95)
- Biowaiver monographs for immediate release solid oral dosage forms: ranitidine hydrochloride. (2005) (95)
- fDA Guidance for Industry 1 Dissolution Testing of Immediate Release Solid Oral Dosage Forms (1997) (93)
- Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic method. (2007) (93)
- 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 (2014) (88)
- Biowaiver monographs for immediate-release solid oral dosage forms: ketoprofen. (2012) (82)
- Review of global regulations concerning biowaivers for immediate release solid oral dosage forms. (2006) (82)
- Griseofulvin levels in stratum corneum. Study after oral administration in man. (1972) (82)
- Statistical Assessment of Mean Differences between Two Dissolution Data Sets* (1996) (81)
- Evaluation of Orally Administered Highly Variable Drugs and Drug Formulations (1996) (77)
- Acyclovir bioavailability in human skin. (1992) (75)
- Methods to Compare Dissolution Profiles* (1996) (75)
- Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products (1999) (75)
- Feasibility of Measuring the Bioavailability of Topical Betamethasone Dipropionate in Commercial Formulations Using Drug Content in Skin and a Skin Blanching Bioassay (2004) (74)
- A Standardized Mini Paddle Apparatus as an Alternative to the Standard Paddle (2008) (74)
- In vitro dissolution of sparingly water-soluble drug dosage forms (1995) (71)
- Evaluation of the test system used for in vitro release of drugs for topical dermatological drug products. (1999) (70)
- GLC determination of theophylline in biological fluids. (1974) (70)
- Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products. (2003) (68)
- Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability (2008) (68)
- Biowaiver monographs for immediate release solid oral dosage forms: rifampicin. (2009) (66)
- Biowaiver monographs for immediate release solid oral dosage forms: prednisolone. (2007) (65)
- 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 (1992) (63)
- The similarity question for biologicals and non-biological complex drugs. (2015) (63)
- Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond (2008) (62)
- Human Intestinal Permeability of Piroxicam, Propranolol, Phenylalanine, and PEG 400 Determined by Jejunal Perfusion (1997) (62)
- A science based approach to topical drug classification system (TCS). (2015) (60)
- Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal Consta. (2011) (60)
- Correlation between the drug penetration and the blanching effect of topically applied hydrocortisone creams in human beings. (1990) (59)
- The Relative Bioavailability and In Vivo-In Vitro Correlations for Four Marketed Carbamazepine Tablets (1998) (58)
- Bioavailability of Clobetasol Propionate – Quantification of Drug Concentrationsin the Stratum Corneum by Dermatopharmacokinetics UsingTape Stripping (1999) (58)
- In Vitro Release of Hydrocortisone from Topical Preparations and Automated Procedure (2004) (57)
- Biowaiver monographs for immediate release solid oral dosage forms: metronidazole. (2011) (57)
- Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products (2014) (56)
- Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development (1992) (56)
- Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: chloroquine phosphate, chloroquine sulfate, and chloroquine hydrochloride. (2005) (56)
- Biowaiver monographs for immediate release solid oral dosage forms: acetazolamide. (2008) (55)
- Biowaiver monographs for immediate release solid oral dosage forms: pyrazinamide. (2008) (55)
- Equivalence of complex drug products: advances in and challenges for current regulatory frameworks (2017) (54)
- Bioavailability of hydrochlorothiazide from tablets and suspensions. (1984) (54)
- Biowaiver monograph for immediate-release solid oral dosage forms: acetylsalicylic acid. (2012) (53)
- Comparison of skin stripping, in vitro release, and skin blanching response methods to measure dose response and similarity of triamcinolone acetonide cream strengths from two manufactured sources. (2002) (53)
- 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. (1996) (53)
- Biowaiver monographs for immediate release solid oral dosage forms: amitriptyline hydrochloride. (2006) (52)
- Dissolution Profile Comparison Using Similarity Factor, f2 (1999) (51)
- Different Pharmaceutical Products Need Similar Terminology (2013) (51)
- Biowaiver monographs for immediate release solid oral dosage forms: ethambutol dihydrochloride. (2008) (50)
- Role of sweat in accumulation of orally administered griseofulvin in skin. (1974) (50)
- In vitro dissolution profile of transdermal nitroglycerin patches using paddle method (1986) (48)
- Impact of adult atopic dermatitis on topical drug penetration: assessment by cutaneous microdialysis and tape stripping. (2009) (47)
- The Effect of Gelatin Cross-Linking on the Bioequivalence of Hard and Soft Gelatin Acetaminophen Capsules (2000) (47)
- Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach (2004) (47)
- Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report (2012) (46)
- Biowaiver monographs for immediate release solid oral dosage forms: prednisone. (2007) (45)
- In Vitro and in Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms (2004) (45)
- Report of the Workshop on In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms (1990) (44)
- Cross‐Linking of Gelatin Capsules and Its Relevance to Their in vitro‐ in vivo Performance (1995) (44)
- The Inhalation Ad Hoc Advisory Panel for the USP Performance Tests of Inhalation Dosage Forms (2008) (43)
- Microultrafiltration technique for drug-protein binding determination in plasma. (1974) (42)
- Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations. (1997) (42)
- Variability in cimetidine absorption and plasma double peaks following oral administration in the fasted state in humans: correlation with antral gastric motility. (2002) (42)
- FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (1997) (42)
- GLC analysis of acetazolamide in blood, plasma, and saliva following oral administration to normal subjects. (1977) (41)
- Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets. (1998) (41)
- Influence of higher rates of agitation on release patterns of immediate-release drug products. (1992) (40)
- Dissolution: A Quality Control Test vs. A Bioequivalence Test (2001) (40)
- Progress in Methodologies for Evaluating Bioequivalence of Topical Formulations (2001) (40)
- Principles and criteria in the development and optimization of topical therapeutic products. (1992) (40)
- Biowaiver monographs for immediate release solid oral dosage forms: metoclopramide hydrochloride. (2008) (40)
- Principles and criteria in the development and optimization of topical therapeutic products. (1992) (39)
- 'Vasoconstriction'--skin blanching--assay for glucocorticoids--a critique. (1989) (39)
- Skin penetration enhancers: scientific perspectives (1994) (38)
- Relationship between in vivo skin blanching and in vitro release rate for betamethasone valerate creams. (1992) (38)
- Steps for Development of a Dissolution Test for Sparingly Water-Soluble Drug Products (2000) (38)
- Biowaiver monographs for immediate release solid oral dosage forms: efavirenz. (2013) (38)
- Biowaiver monographs for immediate release solid oral dosage forms: lamivudine. (2011) (37)
- Impact of the pharmaceutical sciences on health care: a reflection over the past 50 years. (2012) (37)
- Biowaiver monographs for immediate release solid oral dosage forms: Doxycycline hyclate. (2010) (36)
- Determination of griseofulvin in skin, plasma, and sweat. (1972) (36)
- IV-IVC for topically applied preparations--a critical evaluation. (2005) (35)
- Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: “Drug Products, Including Biological Products, that Contain Nanomaterials” (2019) (35)
- Biowaiver monographs for immediate release solid oral dosage forms: levofloxacin. (2011) (35)
- The effect of irritant dermatitis on cutaneous bioavailability of a metronidazole formulation, investigated by microdialysis and dermatopharmacokinetic method (2008) (34)
- Scale-up of Adhesive Transdermal Drug Delivery Systems (1997) (34)
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate. (2017) (34)
- In-vitro release from corticosteroid ointments. (1995) (33)
- Reliability and Reproducibility of Vertical Diffusion Cells for Determining Release Rates from Semisolid Dosage Forms (2007) (32)
- Rediguieri CF, Porta V, Nunes DSG, Nunes TM, Junginger HE, Kopp S, Midha KK, Shah VP, Stavchansky S, Dressman JB, Barends DM. 2011. Biowaiver monographs for immediate‐release solid oral dosage forms: Metronidazole. J Pharm Sci 100:1618–1627. (2011) (31)
- Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report. (2010) (31)
- Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling (1999) (31)
- Biowaiver monograph for immediate-release solid oral dosage forms: fluconazole. (2014) (30)
- Report of the Workshop on Controlled-Release Dosage Forms: Issues and Controversies (1987) (29)
- Passive Transdermal Systems Whitepaper Incorporating Current Chemistry, Manufacturing and Controls (CMC) Development Principles (2012) (29)
- Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas (2012) (28)
- Biowaiver monographs for immediate release solid oral dosage forms: piroxicam. (2014) (28)
- Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology (2010) (27)
- 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 (2014) (26)
- Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride. (2011) (26)
- Conference report: Bio-International 2005. (2007) (26)
- In Vitro Release: Comparative Evaluation of Vertical Diffusion Cell System and Automated Procedure (2003) (25)
- Bioequivalence of Methylphenidate Immediate-Release Tablets Using a Replicated Study Design to Characterize Intrasubject Variability (2000) (25)
- In vivo percutaneous penetration/absorption (1991) (25)
- Comparative in vitro release profiles of marketed nitroglycerin patches by different dissolution methods (1988) (24)
- Variability in the Bioavailability of Phenytoin Capsules in Males and Females (2001) (24)
- Evaluation of the absorption from 15 commercial theophylline products indicating deficiencies in currently applied bioavailability criteria (1980) (24)
- Lack of In Vivo/In Vitro Correlations for 50 mg and 250 mg Primidone Tablets (1998) (24)
- Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine. (2015) (23)
- AAPS-FDA workshop white paper: Microdialysis principles, application, and regulatory perspectives report from the Joint AAPS-FDA Workshop, November 4–5, 2005, Nashville, TN (2007) (23)
- Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Enalapril. (2017) (22)
- Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products. (2011) (22)
- In vitro release profile of estradiol transdermal therapeutic systems. (1990) (22)
- Topically applied griseofulvin in prevention and treatment of Trichophyton mentagrophytes. (1975) (22)
- Thiazides. VIII: Dissolution survey of marketed hydrochlorothiazide tablets. (1983) (22)
- Simple high-pressure liquid chromatographic determination of trisulfapyrimidines in human serum. (1978) (21)
- Phenytoin I: in vitro-in vivo correlation for 100-mg phenytoin sodium capsules. (1983) (21)
- Factors to be considered in the evaluation of bioavailability and bioequivalence of topical formulations. (1992) (21)
- Principles and Criteria in the Development and Optimization of Topical Therapeutic Products (1992) (21)
- Biowaiver monographs for immediate-release solid oral dosage forms: codeine phosphate. (2014) (21)
- The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead? (2013) (21)
- Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam. (2015) (21)
- In Vitro Topographical Characterization as a Predictor of in Vivo Controlled Release Quinidine Gluconate Bioavailability (1986) (20)
- Three-Stage Sequential Statistical Dissolution Testing Rules (2004) (20)
- Determination of the formation of the stratum corneum reservoir for two different corticosteroid formulations using tape stripping combined with UV/VIS spectroscopy (2004) (20)
- Bioavailability of hydrocortisone from commercial 20-mg tablets. (1984) (19)
- in Vitro Dissolution Profile Comparison and IVIVR (1997) (19)
- Biowaiver monographs for immediate-release solid oral dosage forms: quinine sulfate. (2012) (19)
- Interference with measurements of certain drugs in plasma by a plasticizer in vacutainer tubes. (1982) (19)
- From Drug Delivery Systems to Drug Release, Dissolution, IVIVC, BCS, BDDCS, Bioequivalence and Biowaivers (2010) (19)
- Dissolution/In Vitro Release Testing of Special Dosage Forms* (2002) (18)
- Topical 0.050% betamethasone dipropionate. Pharmacokinetic and pharmacodynamic dose-response studies in humans. (1994) (18)
- In vitro drug release measurement for topical glucocorticoid creams (1993) (18)
- FIP Guidelines for Dissolution Testing of Solid Oral Products. (2018) (18)
- Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report. (2011) (18)
- Analysis of in Vitro Dissolution of Whole vs. Half Controlled-Release Theophylline Tablets (1987) (18)
- Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report (2014) (18)
- DISSOLUTION PROFILES OF RESIN-BASED ORAL SUSPENSIONS (1991) (17)
- Importance of media selection in establishment of in vitro-in vivo relationships for quinidine gluconate (1982) (17)
- Crosslinking Of Gelatin Capsules And Its Relevance To Their In Vitro/In Vivo Performance (1995) (17)
- 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 (1997) (17)
- Historical perspective on the development and evolution of bioanalytical guidance and technology. (2011) (17)
- In Vitro Release Profiles of Clonidine Transdermal Therapeutic Systems and Scopolamine Transdermal Patches (1989) (17)
- Scaleup of Immediate Release Oral Solid Dosage Forms (1993) (17)
- Topically applied antifungal agents. Percutaneous penetration and prophylactic activity against trichophyton mentagrophytes infection. (1977) (17)
- Bioequivalence of Topical Dermatological Dosage Forms – Methods of Evaluation of Bioequivalence (1998) (16)
- The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance (1999) (16)
- Biowaiver monographs for immediate release solid oral dosage forms: quinidine sulfate. (2009) (16)
- Topographical Dissolution Characterization for Controlled Release Products - a New Technique (1986) (16)
- Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid. (2017) (16)
- The Role of Dissolution Testing in the Regulation of Pharmaceuticals: The FDA Perspective (2005) (16)
- Phenytoin II: in vitro-in vivo bioequivalence standard for 100-mg phenytoin sodium capsules. (1983) (16)
- Biowaiver monographs for immediate release solid oral dosage forms: amodiaquine hydrochloride. (2012) (16)
- Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin (2016) (15)
- Influence of Tablet Dissolution on Furosemide Bioavailability: A Bioequivalence Study (1987) (15)
- Stable-isotope methodology in the bioavailability study of 17 alpha-methyltestosterone using gas chromatography-mass spectrometry. (1986) (15)
- Transdermal Drug Delivery System Regulatory Issues (2002) (15)
- Release of Hydrocortisone from a Cream Matrix: Dependency of Release on Suspension Concentration and Measurement of Solubility and Diffusivity (2001) (15)
- The Bioavailability of Dermatological and Other Topically Administered Drugs (1986) (15)
- Bioavailability of sulfonamide suspensions I: Dissolution profiles of sulfamethizole using paddle method. (1978) (15)
- Biowaiver monograph for immediate-release solid oral dosage forms: bisoprolol fumarate. (2014) (14)
- Electron Capture Gas Chromatographic Assay for Miconazole and Clotrimazole In Skin Samples (1978) (13)
- Biowaiver monographs for immediate-release solid oral dosage forms: primaquine phosphate. (2012) (13)
- Rethinking the Use of Water as a Dissolution Medium (1999) (13)
- The Pharmaceutical Sciences in 2020: Report of a Conference Organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP) (2010) (13)
- Commonality between BCS and TCS. (2016) (13)
- Current Challenges and Future Regulatory Directions in In Vitro Dissolution (1995) (12)
- Biowaiver monographs for immediate-release solid oral dosage forms: stavudine. (2012) (12)
- In vitro assessment of skin permeation from a transdermal system for the delivery of oestradiol (1993) (12)
- Meeting Report: FIP/AAPS Joint Workshop Report: Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms (2011) (11)
- Analysis of Thyroidal Amino Acids in Pharmaceutical Preparations. I - Reverse Phase High Pressure Liquid Chromatography Analysis of Sodium Liothyronine from Tablets (1979) (11)
- Report on the AAPS Immunogenicity Guidance Forum (2019) (11)
- In vitro and in vivo bioequivalence of commerical prednisone tablets (1984) (11)
- In Vivo Percutaneous Penetration/Absorption, Washington, D.C., May 1989 (1991) (11)
- Skin penetration enhancement. Clinical pharmacological and regulatory considerations (1993) (11)
- Practical Considerations in Developing a Quality Control (In Vitro Release) Procedure for Topical Drug Products (1993) (10)
- Topical 0.050% Betamethasone Dipropionate: Pharmacokinetic and Pharmacodynamic Dose-Response Studies in Humans (1994) (10)
- SCALE-UP OF CONTROLLED-RELEASE PRODUCTS : PRELIMINARY CONSIDERATIONS (1992) (10)
- Dissolution: a Continuing Perspective (2004) (10)
- Thiazides XI: partitioning of chlorothiazide in red blood cells after oral administration. (1984) (10)
- Biowaiver monographs for immediate-release solid oral dosage forms: Zidovudine (azidothymidine). (2013) (10)
- Scale-up of liquid and semisolid disperse systems (1995) (10)
- Importance of In Vitro Drug Release (2014) (10)
- Analytical Methods used in Bioavailability Studies: A Regulators Viewpoint (1987) (9)
- Thiazides XII: A Simple HPLC Method for Determination of Thiazides in Urine (1982) (9)
- Bioequivalency and dose proportionality of three tableted promethazine products. (1986) (9)
- In vitro release of phenol from ointment formulations (1997) (9)
- Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report. (2010) (9)
- FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus (2009) (9)
- Preliminary observations on dissolution and bioavailability of triamterene-hydrochlorothiazide combination products. (1984) (9)
- Progressive applications of dissolution, its impact, and implications in the pharmaceutical world. (2013) (8)
- In vitro evaluation of transdermal drug delivery (1995) (8)
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin hydrochloride. (2020) (8)
- PQRI Workshop Report: Application of IVIVC in Formulation Development (2014) (8)
- In vitro and in vivo testing and correlation for oral controlled/ modified release dosage forms. report of the 2nd workshop held December 1988, Washington, DC. U.S.A. (1990) (8)
- AAPS–FIP Summary Workshop Report: Pharmacogenetics in Individualized Medicine: Methods, Regulatory, and Clinical Applications (2009) (8)
- In vitro and in vivo bioequivalence of commercial prednisone tablets. (1984) (8)
- Topical Drug Bioavailability, Bioequivalence, and Penetration (2014) (8)
- Scale-up of oral extended-release dosage forms (1995) (8)
- Performance Test for Parenteral Dosage Forms (2015) (8)
- Evaluation of basket and paddle dissolution methods using different performance standards. (1983) (8)
- Comparison of plasma and urine analyses for thiazides in bioavailability/bioequivalence study. (1981) (8)
- Transdermal Drug Delivery Systems (2014) (7)
- Use of Reflectance Spectrophotometry in the Human Corticosteroid Skin Blanching Assay (1993) (7)
- Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report (2010) (7)
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Sitagliptin phosphate monohydrate. (2021) (7)
- In vitro release of betamethasone dipropionate from petrolatum-based ointments. (1996) (7)
- Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Metformin Hydrochloride. (2021) (7)
- Thiazides IV: Comparison of dissolution with bioavailability of chlorothiazide tablets. (1982) (7)
- Scaleup of Oral Extended-Release Dosage Forms (1993) (7)
- Workshop report : scale-up of immediate release oral solid dosage forms (1992) (7)
- Workshop III Report: Scaleup of Liquid and Semisolid Disperse Systems (1994) (7)
- Bioavailability and dissolution behavior of trisulfapyrimidine suspensions. (1979) (7)
- ROLE OF IN VITRO RELEASE MEASUREMENT IN SEMISOLID DOSAGE FORMS (1999) (7)
- In vitro dissolution profile comparison and IVIVR. Carbamazepine case. (1997) (7)
- Effect of dietary fat content on the bioavailability of a sustained release quinidine gluconate tablet. (1990) (7)
- In vitro and in vivo evaluation of three metronidazole topical products (2014) (7)
- Comparison of ultraviolet and liquid chromatographic methods for dissolution testing of sodium phenytoin capsules. (1986) (6)
- Non-biological complex drugs (NBCDs) and their follow-on versions: time for an editorial section (2015) (6)
- Influence of dioctyl sodium sulfosuccinate on the absorption of tetracycline. (1986) (6)
- Effect of Various Operational Parameters on Drug Release from a 1% Hydrocortisone Semisolid Dosage Form Using the Vertical Diffusion Cell Apparatus (2012) (6)
- Bioequivalence of Topical Dermatological Products (1993) (6)
- Novel Metrics to Compare Dissolution Profiles (2002) (6)
- Workshop report on in vivo percutaneous penetration/absorption. Washington D.C., May 1-3, 1989. (1991) (6)
- In Vitro Release from Semisolid Dosage Forms—What Is Its Value? (2005) (5)
- Role of Dissolution Testing in Regulating Pharmaceuticals (1999) (5)
- New and generic trandermal nitroglycerin systems : regulatory considerations (1995) (5)
- Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Cephalexin Monohydrate. (2020) (5)
- Drug assay interference caused by plasticizer in Vacutainers. (1982) (5)
- Application of In Vitro Release Methods to Assure Product Performance of Semisolid Dosage Forms Before and After Certain Post-Approval Changes (1998) (5)
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine. (2021) (5)
- Tackling the challenges of nanomedicines: are we ready? (2021) (5)
- Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products: Current Challenges and Future Prospects (2014) (5)
- Progressively Reducing Regulatory Burden (2014) (5)
- Continuing Equivalence: Is There an End to the Story? (2008) (4)
- Challenges with Successful Commercialization of Biosimilars (2019) (4)
- In vitro Release Test (IVRT): Principles and Applications. (2022) (4)
- Workshop on the challenges in substitution of nonbiological complex drugs. (2013) (4)
- TOPICAL CORTICOSTEROIDS: QUALITY CONTROL CONSIDERATIONS (1992) (4)
- Thiazides I. Limitations of Bratton-Marshall Colorimetric Assay Method and Its Modifications in the Determination of Chlorothiazide in Bioequivalency Studies (1980) (4)
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron. (2019) (4)
- Importance of In Vitro Release Measurement in Topical Dermatological Dosage Forms (2002) (4)
- Is the EU ready for non-biological complex drug products? (2016) (4)
- Assessment of Topical Corticosteroid Bioavailability In Vivo and In Vitro (1993) (4)
- Challenges in evaluating bioequivalence of dermatological drug products. (1995) (3)
- MEETING REPORT: Dissolution Testing of Special Dosage Forms (1999) (3)
- Bioequivalence of immediate‐release theophylline capsules † (1999) (3)
- A progress report on the 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence (2019) (3)
- Concept of Mapping (1996) (3)
- Rheological and in vitro release measurements of manufactured acyclovir 5% creams: confirming sensitivity of the in vitro release (2021) (3)
- Dissolution profiles and specifications for dihydroergotoxine sublingual tablets using a new in vitro method. (1981) (3)
- Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Proguanil Hydrochloride. (2018) (3)
- In Vivo and In Vitro Correlations (2019) (3)
- Application of Flow Programming in the Analysis of Drugs and Their Metabolites in Biological Fluids (1983) (2)
- Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? (2010) (2)
- Effects of short-term moderate storage stress on the disintegration and dissolution of four types of compressed tablets. (1984) (2)
- Center of Experimental and Applied Cutaneous Physiology (2001) (2)
- Scale-up of adhesive transdermal drug delivery systems☆☆☆★ (1997) (2)
- AEROPERL® 300 Pharma Improving the dissolution of poorly soluble APIs (2016) (2)
- Are European marketed acyclovir 5% cream products similar? Comparison with EU and US reference product (2021) (2)
- Regulatory Framework for Biosimilars (2013) (2)
- Thiazides III. Evidence of dose proportionality of hydrochlorothiazide 25, 50 and 100 mg tablets. (1983) (2)
- Summary Report:Nanomedicines: Technical and Regulatory Perspectives, Co-sponsored by: USP, AAPS, and FIP (2017) (2)
- Meeting report: International workshop on implementation of biowaivers based on the biopharmaceutics classification system (BCS) (2015) (2)
- Migration of drugs across the skin after oral administration: griseofulvin (1987) (2)
- Regulatory Aspects Pertinent to the Development of Transdermal Drug Delivery Systems (1986) (2)
- Griseofulvin absorption per os and percutaneous. (1980) (2)
- Pharmacodynamic (PD) Bioequivalence (BE) Studies on Betamethasone Dipropionate Cream (BPC) (1996) (2)
- In Vitro Product Quality Tests and Product Performance Tests for Topical and Transdermal Drug Products (2014) (1)
- In Vitro Testing: Dissolution Profile Comparison (2018) (1)
- Corrigendum to “Variability in cimetidine absorption and plasma double peaks following oral administration in the fasted state in humans: correlation with antral gastric motility” [Eur. J. Pharm. Biopharm. 53 (2002) 37–47] (2002) (1)
- Absorption of chlorothiazide and hydrochlorothiazide. (1984) (1)
- Thiazides XIII: Dissolution testing: a bioavailability predictor for benzthiazide tablets. (1982) (1)
- FIP/WHO/CHINA Bioequivalence and Hands-on-Dissolution Workshop Report Beijing, China, April 12–13, 2004 Shanghai, China, April 15–16, 2004 (2004) (1)
- Reply to “Assessment of Variance in Bioavailability Studies: Comments on the Article by McNamara et al.” by Carl M. Metzler. (1988) (1)
- The pharmaceutical sciences in 2020--report of a conference organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP). (2009) (1)
- Regulatory Issues and Drug Product Approval for Biopharmaceuticals (2007) (1)
- In vivo percutaneous penetration / absorption Sponsored by the American Association of Pharmaceutical Scientists (2002) (1)
- Key Elements of Bioanalytical Method Validation for Macromolecules (2007) (1)
- Development of the SUPAC-SS guidance : Scientific issues, process, and chronology (1997) (1)
- Comparative dissolution of commercuially available hydroxyzine hydrochloride tablets (1992) (1)
- Challenges in Evaluating Bioequivalence of Topical Dermatological Drug Products (2014) (1)
- 7th Dermadays, Witten, April 21–22, 2010 (2010) (0)
- International Conference Summary: Regulatory Workshop on Bioequivalence and Dissolution (2008) (0)
- Regulatory Science in Drug Development (2021) (0)
- Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine dihydrochloride. (2022) (0)
- Bioavailability and Bioequivalence of Transdermal Drug Delivery Systems (1993) (0)
- In vivo-in vitro correlations for trisulfapyrimidine suspensions. (1983) (0)
- Workshop Report: Implementation of Biowaivers based on the Biopharmaceutics Classification System (2017) (0)
- Table1. EffectofDrugs ontheDetermination ofProteinConcentration In UrinebyThreeDifferent Methods (1982) (0)
- Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products (2014) (0)
- SIG-BA/BE: Its Structure, Functions and Activities (2002) (0)
- Biowaiver monograph for immediate-release dosage Forms: Levamisole hydrochloride. (2022) (0)
- 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 (2014) (0)
- Interference in plasma level measurements of certain drugs due to a plasticizer in Vacutainers. (1982) (0)
- FIP/WHO/CHINA Bioequivalence and Hands-on-Dissolution Workshop Report (2004) (0)
- Variability in the elimination of trisulfapyrimidines in man. (1983) (0)
- How to Regulate Nonbiological Complex Drugs (NBCD) and Their Follow-on Versions: Points to Consider (2013) (0)
- The Relations Between Q3 Measurements, In vitro Release and TCS (2021) (0)
- In Vitro Release from Semisolid Dosage Forms (2021) (0)
- Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas (2012) (0)
- Progressively Reducing Regulatory Burden (2014) (0)
- Report of the Workshop on Controlled Release Dosage Forms: Issues and Controversies: Academy of Pharmaceutical Sciences American Society for Clinical Pharmacology 3 Therapeutics Drug Information Association and Food and Drug Administration (1988) (0)
- 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 (2014) (0)
- Role of sweat in accumulation of griseofulvin in skin. (1972) (0)
- `Vasoconstriction'\p=m-\Skin Blanching\p=m-\Assay for Glucocorticoids\p=m-\a Critique (2017) (0)
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