Publication
Stop Costly Phase III Failures
By Murray P. Ducharme, PharmD, FCCP, FCP
Published as a supplement to the June 2009 Issue of Applied Clinical Trials
Scientific Exchange
Innovative industry leaders dedicated to collaborating, educating and sharing our groundbreaking expertise on Phase I/IIa services.
As experts with nearly 30 years of experience in clinical research and development, we understand what matters most—that a dynamic exchange of information benefits all of us.
Each of our sites conducts collaborative research with leading pharmaceutical, biotech and generic companies. We make the results of this open forum between industry leaders available here to benefit the healthcare industry and scientific community with our collective expertise.
Click below to see a full library of our posters, presentations, and publications.
Clinical Pharmacology
Phase I
Poster
Hypothermic Effect Observed Following Orally Administered Risperidone in Healthy Subjects
Mec M, Gosai P, Dubins D, Moisan R, and Patel D, Patel P
Presented at the AAPS 2006 Annual Meeting and Exposition
Cardiac Safety/Thorough QT
Publication
ABCs of Thorough QT
By Alan K. Copa, PharmD
Published in the November 2010 Cardiac Safety Supplement to Applied Clinical Trials
Publication
In Search of Innovation
By Alan K. Copa, PharmD
Published in the December 2010 issue of European Pharmaceutical Contractor
Publication
Critical Elements of a TQT Trial: Design and Conduct
By Murray P. Ducharme, PharmD, FCCP, FCP; Graham K. Wood, PhD; and Alan K. Copa, PharmD
Publication
Pitfalls in TQT Studies
By Murray P. Ducharme, PharmD, FCCP, FCP; Graham K. Wood, PhD; and Alan K. Copa, PharmD
Presentation
Healthy Normal vs. Patient Volunteers & Sample Size Determination & Number of Cohorts
By Jeffrey S. Litwin, MD, Executive Vice President and Chief Medical Officer, eResearchTechnology, Inc.
Presented at the Scientific Symposium on Cardiac Safety, November 2007
Click here to download the audio only
Presentation
Number and Timing of Readings & Choosing the Right Does
By Lawrence Z. Satin, MD, FACC, Chief Medical Officer, Cardiocore
Presented at the Scientific Symposium on Cardiac Safety, November 2007
Click here to download the audio only
Presentation
The Clinical Operational Execution Approach of TQT Trials
By Alan Copa, PharmD, President – Fargo & East Grand Forks, Cetero Research
Presented at the Scientific Symposium on Cardiac Safety, November 2007
Click here to download the audio only
Click here to download the Open Exchange audio
Bioavailability / Bioequivalence
Poster
Bioequivalence Potential of a New Extended-Release Formulation Determined by Clinical Trial Simulations
Colucci P, Turgeon J and Ducharme M
Presented at the ACCP/ESCP 2009 International Congress
Poster
How Long Should One Sample for Proper PK Characterization in BA/BE Studies?
Colucci P, Turgeon J, and Ducharme M
Presented at the AAPS 2008 Annual Meeting and Exposition
Bioanalytical
Bioanalytical
Poster
High-Throughput LC/MS/MS Analysis of 2,6-Xylidine, the Toxic Metabolite of Lidocaine, in Rabbit Plasma
Podagatlapalli V, Zickafoos A, Martinez J, Sanduja R, McManus K, Wong J and Pamidi C
Presented at the AAPS 2009 Annual Meeting
Poster
Highly-Sensitive Quantification of Loperamide in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry
Kragerud S, Dinnel A, Grochow C, Nona R, Khadang A and Pamidi C
Presented at the AAPS 2009 Annual Meeting
Poster
Development and Validation of an Extraction Method with Alumina Columns for TBI Determination in Presence of Drug-Iron Complexes in Human Serum Samples
Chen K , Hoang T, Pham J, Koenig R, Perrin M, Ducharme M, and Hulse J
Presented at the AAPS 2008 Annual Meeting and Exposition
Presentation
Automated Liquid-Liquid Extraction of Dihydroergotamine in Human Plasma with Quantitation by HPLC - Tandem Mass Spectrometry
Heidrich J, Meyer M, Zhang Y, Baum L, Osenga A, Aufman D, and Khadang A
Presented at the ASMS 2007 Annual Meeting
Publication
Novel Method for the Determination of Ursodiol and the Conjugates of Ursodiol in Human Plasma by LC/MS/MS
Chakravarthy V, Sanduja R, Wong J, McManus K, Likhari P, and Hulse J
Presented at the AAPS 2006 Annual Meeting and Exposition
Poster
Quantitation of Loratadine and Descarboethoxy Loratadine in Human Plasma by HPLC - Tandem Mass Spectrometry using API 5000
Meyer M, Amundson M, Baum L, Hoffman D, Osenga A, and Khadang A
Presented at the ASMS 2006 Annual Meeting
Poster
Quantitative Analysis of Phenylephrine in Human Plasma by Turbo Ionspray LC-MS/MS
Lindemann J, Hardmeyer G, Meyer M, Baum L, and Aufman D
Presented at the ASMS 2006 Annual Meeting
Poster
Quantitative Determination of Letrozole in Human Plasma: an Application of High Performance Liquid Chromotography/Atmospheric Pressure Photoionization (APPI) Tandem Mass Spectrometric Analysis
Zhang Y, Ackerland C, Meyer S, Pelletier L, Hendrickson S, Jenson S, Pellerano M, Kelsey T, Aufman D, and Khadang A
Presented at the AAPS 2006 Annual Meeting and Exposition
Poster
Quantitative Determination of Oxybutynin and Desethyloxybutynin in Human Plasma Using LC/MS/MS
Baum L, Hoffman D, Rindahl N, Amundson M, Meyer M, Malmberg K, Edwards R, and Khadang A
Presented at the AAPS 2006 Annual Meeting and Exposition
Poster
Recommendations for Incurred Samples Reanalysis: Number of Samples and Method of Assessment of Reproducibility
Hulse J, Pamida C, Wong J, Khadang A, O'Connor D, and Ducharme M
Presented at the AAPS 2006 Annual Meeting and Exposition
Poster
A Validated Method for Glyburide and Metformin in Human Plasma by Liquid Chromatography/Tandem Mass Spectrometry
Bojja S, Zhu L, Zhang Z, Cooper A, and Thiessen JJ
Presented at the AAPS 2005 Annual Meeting and Exposition
Presentation
Developing a High Sensitivity Method for Quantitation of Fluticasone Propionate in Human Plasma by Heated Nebulizer LC/MS/MS
Deng M, Cooper A, and Thiessen JJ
Presented at the ASMS 2005 Annual Meeting
Poster
Automated Solid Phase Extraction of Fexofenadine, Pseudoephedrine, and Cetirizine from Human Plasma and Subsequent Quantitation by LC/MS/MS
Brooks R, Pederson D, Hoffman D, Meyer M, Baum L, Kragerud S, Nelson R, Dolliver J, Dinnel A, and Khadang A
Poster
High Throughput Analysis of Rabeprazole in Human Plasma by LC/MS/MS
Aufman D, Hardemeyer G, Ackerland C, Amundson M, and Khadang A
Environmental Exposure Chambers
Pollen Chamber Models
Poster
An Environmental Exposure Chamber (EEC) Allergy Headache Model: Retrospective Study of Development of Allergy and Headache in EEC Studies of Patients with Seasonal Allergic Rhinitis
Nelson, V, McCue, S and Salapatek, A
Presented at the ACAAI 2009 Annual Meeting
Poster
Captisol-Enabled® Budesonide + Azelastine HCl Nasal Spray Significantly Reduces Total Symptoms Scores (TSS) Compared to Placebo in Ragweed Allergic Patients in an Environmental Exposure Chamber (EEC) Model
Zimmerer RO, Pipkin JD, Salapatek AM, D’Angelo P, Bates M, Patel D and Patel P
Presented at the RDD Europe 2009 Meeting
Poster
Novel Combination Product Captisol-Enabled® Budesonide+Azelastine HCl Provides Fast, Long-lasting Relief of Allergic Rhinitis Symptoms (Total Nasal Symptom Score (TNSS) and Individual Nasal Symptoms Scores (NSS)) in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC) Model
Salapatek AM, D'Angelo P, Bates M, Patel D, Patel P, Pipkin JD and Zimmerer R Presented at the AAAAI 2009 Annual Meeting
Poster
Novel Solubilization of Azelastine and Budesonide with Captisol in a Convenient Combination Nasal Spray Format Provides Faster and Greater Nasal Symptom Relief than Either Captisol-enabled Budesonide or Rhinocort Aqua Alone: a Meta-analysis of Two Environmental Exposure Chamber (EEC) Studies
Salapatek AM, D'Angelo P, Liu J, McCue S, Pipkin JD and Zimmerer R
Presented at the EAACI 2009 Annual Meeting
Poster
The Combination Product Captisol-Enabled® Budesonide+Azelastine HCl Nasal Spray Provides Significant, Long-lasting Relief of Ocular Allergy Symptoms in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC)
Patel P, Salapatek AM, D'Angelo P, Bates M, Patel D, Zimmerer R and Pipkin JD Presented at the AAAAI 2009 Annual Meeting
Poster
Captisol-Enabled® Budesonide Provides Fast-, Long-Acting Relief of Allergic Rhinoconjunctivitis Symptoms: Evidence from a Clinical Trial Shows Significant Total Symptom Score (TSS) and Total Ocular Symptom Score (TOSS) Reduction with Captisol-Enabled® Budesonide Compared to Rhinocort Aqua® and Placebo in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber (EEC) Model.
Salapatek AM, Patel P, Patel D, Pipkin JD, and Zimmerer RO
Presented at the ACAAI 2008 Meeting
Poster
Evaluation of an Emax Clinical Study Design to Test Clinical Equivalence of Inhaled Steroids (INS)
Patel P, Moisan R, Clark B, Cheng J, Desai J, and Salapatek AM
Presented at the ATS 2008 Annual Meeting
Poster
Levocetirizine, but Not Montelukast, is Effective in Alleviating Ocular Symptoms in Allergic Patients Exposed to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Model
Salapatek AM, Pozza L, Patel D, and Patel P
Presented at the ARVO 2008 Annual Meeting
Poster
Ocular Symptoms are Significantly Improved by Budesonide Nasal Solution (Captisol-Enabled®) Compared to Micronized Suspension (Rhinocort Aqua®) or Placebo in Patients with Seasonal Allergic Conjunctivitis (SAC) Studied in an Environmental Exposure Chamber (EEC) Model
Pozza L, Salapatek AM, Patel D, Pipkin JD, Zimmerer Jr. RO, Patel P
Presented at the ARVO 2008 Annual Meeting
Poster
Quality of Life (QOL) in Ragweed Allergic Patients Treated with Captisol-Enabled® Budesonide Nasal Solution (32 µg/spray) When Exposed to Ragweed Pollen in an Environmental Exposure Chamber (EEC) Using an EEC-Specific Rhinoconjunctivitis Quality of Life Questionnaire (EEC-RQOLQ)
Salapatek AM, McCue S, Patel D, Patel P, Pipkin JD, and Zimmerer RO Jr.
Presented at the AAAAI 2008 Annual Meeting
Published in Journal of Allergy and Clinical Immunology 2008;121(2)S1:S55.
Poster
Seasonal Allergic Rhinitis Studies Conducted in An Environmental Exposure Chamber are Highly Reproducibile: Three Clinical Studies of Olopatadine Nasal Spray Demonstrate an Identical Therapeutic Response
Pozza L, Wall M, Salapatek AM and Patel P
Presented at the EAACI 2008 Annual Meeting
Poster
Aerodynamic Properties of Milled Allergen Products: Preparation of “Standard”, Air-suspendable Dog, Cat, Cockroach and Mite Allergen Powders
Freihaut J, Chapman M, Salapatek AM, Patel P, and McCue S
Presented at the EAACI 2007 Congress
Published in Allergy 2007;62(s83):38.
Poster
An Environmental Exposure Chamber (EEC)-specific Rhinoconjunctivitis Quality of Life Questionnaire: The Symptoms of Seasonal Allergic Rhinitis Correlate with the Quality of Life of Patients with Ragweed Allergy in the EEC
Salapatek AM, Patel P, Chan K, Talwar N, Fischer von Weikersthal-Drachenberg K, and Amersdorffer J
Presented at the EAACI 2007 Congress
Published in Allergy 2007;62(s83):118.
Poster
Captisol-Enabled® Budesonide Nasal Spray Significantly Reduces Total Nasal (TNSS) and Non-Nasal Symptoms (TNNSS) Compared to Rhinocort Aqua® and Placebo in Ragweed Allergic Patients in a Environmental Exposure Chamber (EEC) Model
Salapatek AM, McCue S, Benz M, Eisfeld B.S, Mancinin D, Patel P, Pipkin JD, and Zimmerer RO Jr.
Presented at the ACAAI 2007 Annual Meeting
Published in Annals of Allergy, Asthma and Immunology 2008; 100(1) suppl:A93.
Poster
Development of Asthma Study Technologies in an Environmental Chamber (ASTEC)
Salapatek AM, Patel P, Nimraj L, Ramoutar A, Chapman MD, and Freihaut JD
Presented at the AAAAI 2007 Annual Meeting
Published in Journal of Allergy and Clinical Immunology 2007;119(1)S1:S3.
Poster
Increased IgG Levels Induced by Ragweed MATA MPL® in Ragweed Allergic Patients Studied in an Environmental Exposure Chamber are Maintained During Follow-Up in the Natural Ragweed Pollen Season
Patel P, Salapatek AM, McCue S, Fischer von Weikersthal-Drachenberg K, and Amersdorffer J
Presented at the EAACI 2007 Congress
Published in Allergy 2007;62(s83):231.
Poster
Lack of Effect on Hypothalamic-Pituitary-Adrenal-Axis (HPA) Function by Once-daily Fluticasone Furoate Nasal Spray (FFNS) 110 mcg in Adolescents and Adults with Perennial Allergic Rhinitis (PAR)
Patel D, Ratner P, Clements D, Wu W, Faris M, and Philpot E
Presented at the AAAAI 2007 Annual Meeting
Published in Journal of Allergy and Clinical Immunology 2007;119(1)S1:S305.
Poster
Levocetirizine is More Effective than Montelukast in Improving Symptoms of Seasonal Allergic Rhinitis in Subjects Exposed to Ragweed Pollen in the Environmental Exposure Chamber
Patel D and Patel P
Presented at the ACAAI 2007 Annual Meeting
Published in Annals of Allergy, Asthma and Immunology 2008; 100(1) suppl:A86.
Poster
Seasonal Allergic Rhinitis Symptoms Correlate with the Quality of Life in Patients with Ragweed Allergy in the Environmental Exposure Chamber (EEC) Model
Salapatek AM, McCue S, Sauve H, and Patel P
Presented at the WAC 2007 Annual Meeting
Published in World Allergy Organization Journal 2007;Nov:S74.
Poster
The Correlation between Allergen Skin Prick Test (SPT) Wheal Diameters and Nasal Symptoms to Aeroallergen Challenge in Environmental Exposure Chamber (EEC)
Wilson D, Salapatek AM, Patel P, and Tanna P
Presented at the AAAAI 2007 Annual Meeting
Published in Journal of Allergy and Clinical Immunology 2007;119(1)S1:S142.
Poster
Evaluation of the Safety and Immunogenicity of Pollinex® Quattro Grass in Patients Suffering from Grass and Rye Allergies
Patel P, Salapatek AM, Shah C, Tanna P, Iyer D., Fischer von Weikersthal-Drachenberg K, and Amersdorffer J
Presented at the ACAAI 2006 Annual Meeting
Poster
Effect of ‘Priming’ on Predose Symptom Scores in Environmental Exposure Chamber (EEC) Study Design
Patel P, Rai K, Benninger PJ, Kaji Y, Margalias H, and Moisan R
Presented at the AAAAI 2005 Annual Meeting
Poster
Olopatadine Nasal Spray 0.6% vs. Placebo and NASONEX® in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber
Patel D, Wall M, Brubaker M, Garadi R, Conroy P, Yoshiko K, Crenshaw K, and Whitling A
Presented at the ACAAI 2005 Annual Meeting
Non-Allergic Rhinitis Chamber Models
Presentation
The Non-Allergic Rhinitis (NAR) Environmental Exposure Chamber Model Evokes Consistent and Significant Nasal Symptoms in NAR Patients but not in Healthy Normal Volunteers
By Salapatek, A, Wilson, D, Liu, J, Song, Y, D’Angelo, P, Patel, D. Tsitoura, D, Murdoch, R, Bernstein, JA, Lee, JS
Presented at the 2010 European Academy of Allergology and Clinical Immunology Annual Meeting
Request a reprint
Objective and Subjective Responses to Simulated Weather Changes in Non-Allergic Rhinitis (NAR) Patients Using a Novel Environmental Exposure Chamber (EEC) Model
By Lee J.S., Wilson D, Patel D, Bernstein J.A., D’Angelo P and Salapatek A
Presented at the 2009 American College of Allergy, Asthma and Immunology Annual Meeting
Request a reprint
Quality of Life Improved in Ragweed Allergic Patients Treated with Captisol-Enabled® Budesonide+Azelastine Nasal Solution (CDX-313) Compared to Placebo and Reference Treatment (As + RA) Using an Environmental Exposure Chamber-specific Rhinoconjunctivitis Quality of Life Questionnaire (EEC-QOL)
By Salapatek, A, McCue, S, Zimmerer, R.O. and Pipkin, J.D.
Presented at the 2009 American College of Allergy, Asthma and Immunology Annual Meeting
Request a reprint
The Use of an Environmental Exposure Chamber (EEC) Model for Challenging Non-Allergic Rhinitis (NAR) Patients to Irritant Triggers
By Lee, J.S., Wilson, D, Patel, D, Bernstein, J.A., D’Angelo, P and Salapatek, A
Presented at the 2009 American College of Allergy, Asthma and Immunology Annual Meeting
Poster
Validation of a Novel Clinical Non-allergic Rhinitis (NAR) Model to Evoke Nasal Symptoms in an Environmental Exposure Chamber (EEC): Part 1 - Static and Dynamic Temperature Shift Regimes
Salapatek AM, Wilson D, Lee JSY, Pozza L, Bernstein J, Patel D, and Patel P
Presented at the EAACI 2009 Annual Meeting
Poster
Validation of an Environmental Exposure Chamber (EEC) to Provide Controlled, Natural, Reproducible Exposures to Key Non-allergic Environmental Triggers to Patients with Non-allergic Rhinitis (NAR)
Lee JSY, Pozza L, Wilson D, Nelson V, Murdoch RD, Tsitoura DC, Barney B, Patel P and Salapatek AM
Presented at the EAACI 2009 Annual Meeting
Poster
Development of a Non-Allergic Rhinitis Chamber (NARC) Model
Pozza LM, Barney B, Patel P, and Salapatek AM
Presented at the AAAAI 2008 Annual Meeting
Published in Journal of Allergy and Clinical Immunology 2008;121(2)S1:S233.
Dust Mite Chamber Models
Poster
Dust Mite Allergic (DMA) Patients with Sensitivity to Dermatophagoides pteronyssinus (Der p) and/or Dermatophagoides farinae (Der f) Respond with Significant and Reproducible Nasal Symptoms to Aerosolized Der p in an Environmental Exposure Chamber (EEC) M
Wilson D, Lee J, Camuso N, Patel D and Salapatek A
Presented at the ACAAI 2010 Annual Meeting
Poster
Standardization of Dust Mite Allergen Inhalant for Use in an Environmental Exposure Chamber
Salapatek AM, Freihault JD, Tanna P, Nimraj L, Ramoutar A, Sauve H, Patel P, and Chapman MD
Presented at the ACAAI 2006 Annual Meeting
Dry Eye Chamber Models
Poster
Contact Lenses and Spectacles Compared in a Low Humidity Environment Chamber (LHE):Discernable Differences in Tear Osmolarity, Symptoms and Comfort
F. Soong, J. Lee, A.M. Salapatek and A. Landers
Presented at the AAO (Optometry) 2011 Annual Meeting
Poster
Evaluation Of A Novel Algorithm And Low Humidity Environment Chamber (LHE) To Classify Subjects As Contact Lens Induced Dry Eye (CLIDE) Or Non-CLIDE
F. Soong, J. Lee, A. Landers and A.M. Salapatek
Presented at the AAO (Optometry) 2011 Annual Meeting
Poster
Evaluation of the Efficacy of Dexamethasone to Improve the Signs and Symptoms of Dry Eye Syndrome (DES) in a Low Humidity Environment (LHE) Chamber Model
Soong F, Patel P, Lee JSY, Wilson D and Salapatek AM
Presented at the ARVO 2009 Annual Meeting
Poster
Development of Low Humidity Environment (LHE) Facility for the Clinical Study of Dry Eye Syndrome
McCue S, Barney B, Patel P, and Salapatek AM
Presented at the Tear Film and Ocular Surface Society 2007 Meeting
Cat Chamber Models
Poster
Mild asthmatic patients' responses to a repeated, low dose, allergen challenge in an Environmental Exposure Chamber (EEC) demonstrate a consistent decrease in FEV1 and increase in asthma symptoms
D. Patel, N. Patel, J. Lee, P. Couroux and A.M. Salapatek
Presented at the ERS 2011 Annual Congress
Presentation
Ocular Symptoms Evoked by Allergen Challenge in a Controlled Aerosolized Cat Allergen EnvironmentalExposure chamber (EEC)
By Shannon McCue, Victoria Nelson, Dan Wilson, Salapatek AM
Presented at the 2010 European Academy of Allergology and Clinical Immunology Annual Meeting
Poster
An Aerosolized Cat Allergen Environmental Exposure Chamber (EEC) Model to Study Cat Allergic Patients: Assessment of Airborne Fel d 1 Concentration in Real-Time Ensures Controlled Patient Exposure to Cat Allergen
Nelson, V, McCue S and Salapatek, AM
Presented at the ACAAI 2009 Annual Meeting
Poster
Assessment of Total Nasal Symptom Score (TNSS) during the Validation of a Novel Aerosolized Cat Dander Environmental Exposure Chamber (EEC) Clinical Model
Salapatek AM, Nelson V, Patel P and McCue S
Presented at the ATS 2009 Annual Meeting
Poster
Individual Nasal Symptoms Increase in Cat Allergic Subjects when Exposed to Fel d 1 in a Validated Aerosolized Cat Dander Environmental Exposure Chamber (EEC) Clinical Model
McCue, S, Nelson, V, Wilson, D, Patel, D and Salapatek, AM
Presented at the ACAAI 2009 Annual Meeting
Poster
Validation of Aerosolized Cat Dander in an Environmental Exposure Chamber (EEC) Clinical Model
Nelson V, McCue S, Salapatek AM and Patel P
Presented at the AAAAI 2009 Annual Meeting
Poster
Validation of Fel d 1 Exposure in a Well-Controlled Aerosolized Cat Allergen Environmental Exposure Chamber (EEC)
McCue S, Wilson D, Nelson V, Patel P and Salapatek AM
Presented at the AAAAI 2009 Annual Meeting
Scientific Affairs
Pharmacokinetics / Pharmacodynamics
Poster
An Innovative Multidimensional Dose-Response Relationship to Optimize Piperacillin/Tazobactam Dosing Regimens
Colucci P, Yue CS, Bouziane A, Ang A and Ducharme MP
Presented at the 2010 ASCPT Annual Meeting
Data Management
Publication
From Process to Project: Dramatic changes in the way trials are conducted are rapidly expanding the role and skillsets demanded of data managers
By Denise Redkar-Brown, Colleen Cox and Sharon Kayne Chaplock
Published in the April 2008 issue of GCPj
Early Stage Drug Development Efficiencies
Early Stage Drug Development Efficiencies
Presentation
Combined Phase I and IIa to Accelerate Proof-of-Concept
By Graham Wood, PhD President, Clinical Operations - Toronto & Miami
Presented at Scientific Seminar on An Accelerated Path to Proof-of-Concept in Drug Development, October 2010
Click here to download the video presentation
Presentation
Fit-for-Purpose Biomarker Assay Development and Validation
By Russ Weiner, PhD, Executive Director, Clinical Development Lab
Presented at the Scientific Seminar on An Accelerated Path to Proof-of-Concept in Drug Development, October 2010
Click here to download the video presentation
Publication
Moving Early Phase Trials Forward
By Graham K. Wood, PhD
Published in the June 2010 issue of European Pharmaceutical Contractor
Presentation
First-in-Human Study Designs: Proof-of-Concept with Safety in Mind
By Graham Wood, PhD, Senior Scientific Liaison, Clinical Pharmacology
Presented at the 2008 Ricerca Biosciences "Taking the Biotech from IP to IND" Symposium
Therapeutic Areas
Allergy
Poster
Examination of the Nasal Symptom Response to Conjunctival Allergen Challenge Using Subjective and Objective Measures of Nasal Congestion
Pozza LM, Salapatek AM, Soong F, Wilson D, Patel D and Patel P
Presented at the AAAAI 2009 Annual Meeting
Poster
Fel d 1 Exposure in a Natural Cat Allergen Challenge Room (CACR): Results Using a Purified Allergen Standard
McCue S, Walsh V, Chapman M, Freihaut J, Patel P, and Salapatek AM
Presented at the ACAAI 2008 Meeting
Poster
Nasal Spray Antihistamine (Livostin®) Prophylactic Treatment Improves Ocular Redness Symptoms in a Conjunctival Allergen Challenge Model.
Pozza L, Salapatek AM, Soong F, Wilson D, Patel D, and Patel P
Presented at the ACAAI 2008 Meeting
Poster
Clinical Equivalence of Topical Nasal Products: What Will Follow the FDA Draft Guidance?
Benninger P, Moisan R, Lui Y, Dubins D, Patel D, and Thiessen JJ
Presented at the AAPS 2004 Annual Meeting and Exposition
Asthma
Poster
Assessment of Total IgE, Wheal Response and Fel D 1 Exposure as Predictors of the Asthmatic Response in a Natural Cat Allergen Challenge Room (CACR) Clinical Model
McCue S, Walsh V, Chapman M, Freihaut J, Patel P, and Salapatek AM
Presented at the EAACI 2008 Annual Meeting
Dermatology and Transdermal Delivery Systems
Poster
In Vitro Correlation of Skin Barrier Integrity Tests with the Structure and Function of the Stratum Corneum Barrier
K.L. Hughes, P.A. Lehman, S.G. Raney, J. Singh and T.J. Franz
Presented at the AAPS 2011 Annual Meeting
Poster
Critical Influence of Dose on Release Rate and Depletion Effects in the SUPAC-SS IVRT
S.G. Raney, P.A. Lehman and T.J. Franz
Presented at the AAPS 2011 Annual Meeting
Poster
The Novel Development of a Dual Octanol/Water Skin Barrier Test
K.L. Hughes, P.A. Lehman, S.G. Raney, J. Singh and T.J. Franz
Presented at the AAPS 2011 Annual Meeting
Poster
In Vitro - In Vivo Correlation (IVIVC) of Percutaneous Absorption through Human Skin
Franz T.J. , Lehman P.A. and Raney S.G.
Presented at the AAPS 2010 Annual Meeting
Poster
In Vitro - In Vivo Correlation in Man for Percutaneous Absorption
Franz TJ, Lehman PA and Raney SG
Presented at the PPP 2010 International Conference
Presentation
In Vitro/In Vivo Correlation: Value for In Vitro Absorption Studies to Advance your Formulation to Approval
By Thomas Franz, MD, Executive Medical Director
Presented at Scientific Seminar on Dermatology and Transdermal Delivery Drug Development, September 2010
Click here to download the video presentation
Poster
A Harmonized Study Design Evaluating In Vitro Percutaneous Absorption Using Franz Diffusion Cells Based upon International Guidelines and Expert Consensus
Raney SG, Lehman PA and Franz TJ
Presented at the PPP 2010 International Conference
Presentation
A Review of The New FDA Transdermal Guidances: Insights on Current FDA Thinking for Both Generics and Innovator Transdermal Systems
By Paul Lehman, MSc, Director, Clinical and Pre-Clinical Dermatology
Presented at the Scientific Seminar on Dermatology and Transdermal Delivery Drug Development, September 2010
Click here to download the video presentation
Poster
Evaluating Hydrophobic-Hydrophilic Penetration Pathways through Ex Vivo Human Skin
Hughes K.L., Singh J., Franz T.J., Lehman P.A. and Raney S.G.
Presented at the AAPS 2010 Annual Meeting
Poster
Quality Processes and GLP Compliance for In Vitro Percutaneous Absorption Studies
Raney S.G., Lehman P.A., Franz T.J. and Boschert K.J.
Presented at the AAPS 2010 Annual Meeting
Poster
The Role of Method Development and Validation for In Vitro Rate of Release Studies
Lehman PA, Raney SG and Franz TJ
Presented at the PPP 2010 International Conference
Poster
The Role of QC, QA and GLP for In Vitro Percutaneous Absorption Studies
Raney SG, Lehman PA, Franz TJ and Boschert KJ
Presented at the PPP 2010 International Conference
Presentation
Transdermal Testosterone: An Example of New Challenges for BE Assessments and Topical Transfer for Nonpatch Transdermal Delivery Systems
By Paul Lehman, MSc, Director, Clinical and Pre-Clinical Dermatology
Presented at the Scientific Seminar on Dermatology and Transdermal Delivery Drug Development, September 2010
Click here to download the video presentation
Poster
Validation of the Apparatus utilized for SUPAC-SS In Vitro Release Tests
Raney S.G., Lehman P.A. and Franz T.J.
Presented at the AAPS 2010 Annual Meeting
Poster
Validation of the IVRT Methods utilized for SUPAC-SS In Vitro Release Tests
Lehman P.A., Raney S.G. and Franz T.J.
Presented at the AAPS 2010 Annual Meeting
Poster
A Harmonized Study Design evaluating In Vitro Percutaneous Absorption using Franz Diffusion Cells based upon International Guidelines and Expert Consensus
Raney S, Lehman P and Franz T
Presented at the AAPS 2009 Annual Meeting
Poster
A Hierarchical Approach for Assessing Bioequivalence of Topical Formulations: A Practical Alternative to Clinical BE Studies
Franz T, Lehman P and Raney S
Presented at the AAPS 2009 Annual Meeting
Poster
Correlation of In Vitro Percutaneous Drug Absorption with Water Barrier Integrity Data in Human Skin using the Franz Cell Model
Lehman P, Raney S and Franz T
Presented at the AAPS 2009 Annual Meeting
Poster
Human Cadaver Skin: A Valid Surrogate Model for the Development of Topical and Transdermal Drugs (Further Validation of the Franz Cell for Assessing Bioavailability and Systemic Exposure)
Franz TJ, Lehman PA and Raney SG
Presented at the SOT 2009 Annual Meeting
Poster
Skin Permeability to Water and Octanol using the In Vitro Human Skin Percutaneous Absorption Model with Franz Diffusion Cells
Hughes K, Singh J, Lehman P, Raney S and Franz T
Presented at the AAPS 2009 Annual Meeting
Poster
Terbinafine HCl in a Novel Alcohol Vehicle Permeates the Human Nail and Achieves Therapeutic Concentrations in the Nail Plate and Nail Bed
Waldmeier F, Franz T, Lehman P and Pfister WR
Presented at the AAD 2009 Annual Meeting
Publication
Use of Excised Human Skin to Assess the Bioequivalence of Topical Products
By T.J. Franz P.A. Lehman and S.G. Raney
Published in the August 26, 2009 online issue of Skin Pharmacology and Physiology
Publication
30th Anniversary of the Franz Cell Finite Dose Model: The Crystal Ball of Topical Drug Development
By Sam Raney, PhD; Paul Lehman, MSc; and Thomas Franz, MD
Published in the July/August 2008 Issue of Drug Delivery Technology®
Poster
In Vitro Cadaver Skin Percutaneous Absorption Model: Across Donor Variability; A Retrospective Analysis
Paul A. Lehman, MSc, Thomas J. Franz, MD, and Sam Raney, PhD
Presented at the PPP 2008 International Conference
Poster
Assessment of Reservoir Solution Selection When Using the In Vitro Cadaver Skin Percutaneous Absorption Model
Raney S, Lehman P, and Franz T
Presented at the AAPS 2008 Annual Meeting and Exposition
Poster
Characterization of Age, Race and Sex Differences in the Barrier Function of Human Skin Based on Water Absorption, In Vitro
Lehman P, Raney S, and Franz T
Presented at the AAPS 2008 Annual Meeting and Exposition
Poster
Comparison of International Guidelines for Evaluating In Vitro Percutaneous Absorption
Raney S, Lehman, and Franz T
Presented at the PPP 2008 International Conference
Poster
Evaluation of Full Thickness vs. Dermatomed Skin on Testosterone Percutaneous Absorption Using the In Vitro Cadaver Skin Percutaneous Absorption Model
Franz T, Lehman P, and Raney S
Presented at the AAPS 2008 Annual Meeting and Exposition
Poster
The In Vitro Cadaver Skin Percutaneous Absorption Model: Across Donor Variability - Donor Population Assessment
Lehman L, Raney S, and Franz T
Presented at the PPP 2008 International Conference
Publication
The Cadaver Skin Absorption Model and the Drug Development Process*
By Thomas J. Franz, MS, MD, Paul A. Lehman, MS and Sam G. Raney, PhD
Published in the September-October 2008 issue of Pharmacopeial Forum
Poster
In Vitro/In Vivo Percutaneous Absorption Comparability: A Discussion
Lehman P, Franz T, and Raney S
Presented at the AAPS 2007 Annual Meeting and Exposition
Poster
In Vitro Percutaneous Absorption of Terbinafine on Intact and Stratum Corneum Ablated Human Dorsal Foot Skin
Hensby C, Lehman P, Franz, T, and Annicchiarico J
Presented at the World Dermatology 2007 Conference
Poster
In Vitro Permeation of Terbinafine and Naftifine Through Human Nails from OrganoGel Formulations
Hensby C, Lehman P, Franz, T, and Annicchiarico J
Presented at the World Dermatology 2007 Conference
Poster
A Quality Assurance Approach to Inspecting and Auditing In Vitro Studies Utilizing Franz Cells
Boschert K
Presented at the Society of Quality Assurance 2007 Annual Meeting
Presentation
Role of Cadaver Skin Permeation Assay in New and Generic Drug Development – The Critical Path Initiative and Using the Assay in the Drug Development Process
By Thomas Franz, MD, Executive Medical Director
Presented at the Scientific Symposium on Dermatology, November 2007
Click here to download the audio only
Presentation
The Cadaver Skin Permeation Assay: A Valid Surrogate for BA/BE Assessment – Fundamentals of the Cadaver Skin Assay Focusing on In Vitro/In Vivo Correlation
By Paul A. Lehman, MSc, Director, Clinical and Pre-clinical Dermatology
Presented at the Scientific Symposium on Dermatology, November 2007
Click here to download the audio only
Presentation
In Vitro Bioavailability of Topical Glucocorticoid Products
Lehman P and Franz T
Presented at the AAPS 2006 Annual Meeting and Exposition
Poster
In Vitro Cadaver Skin: Longevity of Barrier Integrity
Lehman P and Franz T
Presented at the AAPS 2006 Annual Meeting and Exposition
Poster
Glucocorticoid Bioavailability: Insensitivity of the Vasoconstrictor Response
Lehman P and Franz T
Presented at the AAPS 2006 Annual Meeting and Exposition
Poster
In Vitro Permeation of Terbinafine through Human Nails from Terbinafine HCL Nail Lacquer Formulations
Lehman P, Franz T, Lu M, and Pfister W
Presented at the AAPS 2005 Annual Meeting and Exposition
Diabetes
Poster
Canagliflozin Improves Glycemic Control in Subjects with Type 2 Diabetes (T2D) Not Optimally Controlled on Stable Doses of Insulin
Schwartz S, Morrow L, Hompesch M, Devineni D, Skee D, Vandebosch A, Murphy J and Pfeifer M
Presented at the 2010 ADA Scientific Sessions
Poster
Farnesoid-X Receptor Agonists: a New Therapeutic Class for Diabetes and Fatty Liver Disease? The First FXR Therapeutic Study in Diabetes
Sunder Mudaliar, Robert Henry, Linda Morrow, Marcus Hompesch, Mark Kipnes, Arun Sanyal, Paul Clopton, Olaf Böhm, Cathi Sciacca, Annie Mavian, Mark Pruzanski, David Shapiro
Presented at the 2010 American Diabetes Association 70th Scientific Sessions
Poster
A Single-Blind, Placebo-Controlled, Food-Dose Timing Trial of Oral HDV-Insulin in Patients with Type 2 Diabetes Mellitus
Geho B, Lau J, Rosenberg L and Schwartz S
Presented at the ADA 2009 Scientific Sessions
Poster
AFRESA™ (Technosphere® Insulin) Dosage Strengths are Interchangeable
Cassidy JP, Baughman RA, Schwartz SL, Haworth PC, Boss AH and Richardson PC
Presented at the ADA 2009 Scientific Sessions
Poster
Assessment of Opioid Withdrawal in Patients Treated with Tapentadol Extended Release for Painful Diabetic Peripheral Neuropathy: Results of a Randomized-Withdrawal Phase 3 Trial
Schwartz S, Shapiro DY, Okamoto A, Lange R and Etropolski M
Presented at the 2009 ASRA Annual Pain Medicine Meeting
Poster
Farnesoid-X Receptor Agonists: a New Therapeutic Class for Diabetes and Fatty Liver Disease? The First FXR Therapeutic Study in Diabetes
Mudaliar S, Henry R, Morrow L, Hompesch M, Kipnes M, Sanyal A, Clopton P, Böhm O, Sciacca C, Mavian A and Pruzanski M
Presented at the ADA 2009 Scientific Sessions
Poster
Pharmacokinetics of AFRESA™ Unchanged in Patients with Chronic Obstructive Pulmonary Disease
Potocka E, Baughman RA, Schwartz SL, Gray MM, Diaz MLM and Richardson PC
Presented at the ADA 2009 Scientific Sessions
Poster
Effect of Colesevelam HCl on Postprandial Glucose, Insulin Sensitivity, and Insulin Secretion in Subjects with T2DM
Schwartz SL, Abby SL, Lai Y, Xu J, Jones MR, Misir S and Nagendran S
Presented at the WCIRS 2008 Annual Meeting
Obesity
Poster
Body Weight Reductions with Low Dose AEGR-733, a Microsomal Triglyceride Transfer Protein Inhibitor: Results from Three Phase 2 Trials
Bays HE, Davidson M, Schwartz S, Price C, Sasiela WJ, Parris M, Meagher E and Rader D
Presented at the ADA 2009 Scientific Sessions
