S. Rohatagi

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Pharmacokinetic/Pharmacodynamic Modeling in Drug Development

Jeffrey S. Barrett, J. Barrett, S. Rohatagi, 2004 .

Pharmacokinetics of Amlodipine and Olmesartan After Administration of Amlodipine Besylate and Olmesartan Medoxomil in Separate Dosage Forms and as a Fixed‐Dose Combination

M. Bathala, M. Shenouda, S. Rohatagi, 2008, Journal of clinical pharmacology.

Pharmacokinetics of Methylprednisolone and Prednisolone After Single and Multiple Oral Administration

H. Möllmann, J. Barth, H. Derendorf, 1997, Journal of clinical pharmacology.

Dynamic Modeling of Cortisol Reduction after Inhaled Administration of Fluticasone Propionate

A Bye, H Derendorf, B. Meibohm, 1996, Journal of clinical pharmacology.

Pharmacokinetics of Triamcinolone Acetonide After Intravenous, Oral, and Inhaled Administration

H. Möllmann, J. Barth, H. Derendorf, 1995, Journal of clinical pharmacology.

Estimating Mass Balance for Inhaled Drugs in Humans: An Example with a VLA‐4 Antagonist, IVL745

B. Jensen, S. Rohatagi, Zhaopie Zeng, 2004, Journal of clinical pharmacology.

Effect of IVL745, a VLA-4 antagonist, on allergen-induced bronchoconstriction in patients with asthma.

S. Holgate, B. O'connor, H. Arshad, 2005, The Journal of allergy and clinical immunology.

Effect of a very late antigen‐4 receptor antagonist on allergen‐induced airway responses and inflammation in asthma

P. Sterk, H. Hoogsteden, Z. Diamant, 2005, Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology.

Optimization of a Digital Medicine System in Psychiatry.

T. Peters-Strickland, S. Rohatagi, Cathy Zhao, 2016, The Journal of clinical psychiatry.

Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation

S. Connolly, J. Weitz, H. Kastrissios, 2010, Thrombosis and Haemostasis.

Use of an Exposure‐Response Model to Aid Early Drug Development of an Oral Sphingosine 1‐Phosphate Receptor Modulator

J. Moberly, S. Rohatagi, K. Truitt, 2009, Journal of clinical pharmacology.

Pain relief model for a COX-2 inhibitor in patients with postoperative dental pain.

J. Moberly, H. Kastrissios, S. Rohatagi, 2008, British journal of clinical pharmacology.

Application of LC-MS In Supporting PK/PD Studies During Drug Discovery And Development

S. Rohatagi, T. Ahmed, 2016 .

A pharmacometric case study regarding the sensitivity of structural model parameter estimation to error in patient reported dosing times

J. Knights, S. Rohatagi, 2015, Journal of Pharmacokinetics and Pharmacodynamics.

Pharmacoscintigraphic Comparison of HMR 1031, a VLA-4 Antagonist, in Healthy Volunteers Following Delivery Via a Nebulizer and a Dry Powder Inhaler

B. Jensen, S. Newman, S. Rohatagi, 2004, American journal of therapeutics.

Deposition and pharmacokinetics of an HFA formulation of triamcinolone acetonide delivered by pressurized metered dose inhaler.

S. Newman, G. Pitcairn, S. Rohatagi, 2001, Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine.

Population Pharmacokinetic Analyses to Evaluate the Influence of Intrinsic and Extrinsic Factors on Exposure of Prasugrel Active Metabolite in TRITON‐TIMI 38

E. Antman, E. Braunwald, S. Wiviott, 2009, Journal of clinical pharmacology.

Development and application of an aggregate adherence metric derived from population pharmacokinetics to inform clinical trial enrichment

J. Knights, S. Rohatagi, 2015, Journal of Pharmacokinetics and Pharmacodynamics.

Correlation of Inhibition of Platelet Aggregation With Cardiovascular and Bleeding Outcomes in Acute Coronary Syndromes

K. Winters, S. Rohatagi, D. Small, 2010, Journal of clinical pharmacology.

Population pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel in aspirin-treated patients with stable coronary artery disease

L. Wallentin, K. Winters, C. Ernest, 2008, Journal of Pharmacokinetics and Pharmacodynamics.

Relationship Between Exposure to Prasugrel Active Metabolite and Clinical Outcomes in the TRITON‐TIMI 38 Substudy

Junxiang Luo, C. Ernest, R. Wrishko, 2012, Journal of clinical pharmacology.

Integrated Analysis of Pharmacokinetic Data Across Multiple Clinical Pharmacology Studies of Prasugrel, a New Thienopyridine Antiplatelet Agent

K. Winters, C. Ernest, N. Farid, 2011, Journal of clinical pharmacology.

Pharmacokinetics of Otamixaban, a Direct Factor Xa Inhibitor, in Healthy Male Subjects: Pharmacokinetic Model Development for Phase 2/3 Simulation of Exposure

A. Frick, R. Rosenburg, B. Jensen, 2006, Journal of clinical pharmacology.

Pharmacokinetic interaction between endogenous cortisol and exogenous corticosteroids.

H. Möllmann, J. Barth, H. Derendorf, 1995, Die Pharmazie.

Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation

E. Antman, R. Giugliano, S. Zhou, 2012, Thrombosis and Haemostasis.

Pharmacokinetic‐Pharmacodynamic Modeling of the Antilipolytic Effects of an Adenosine Receptor Agonist in Healthy Volunteers

B. Jensen, S. Rohatagi, P. Zannikos, 2001, Journal of clinical pharmacology.

Drug Metabolism Human Liver Aldehyde Oxidase: Inhibition by 239 Drugs 7

R. Obach, M. Farré, S. Szefler, 2004 .

Development of a Dry Powder Inhaler, the Ultrahaler®, Containing Triamcinolone Acetonide Using In Vitro-In Vivo Relationships

S. Rohatagi, B. Shah, J. Lim, 2006, American journal of therapeutics.

Risk‐Benefit Value of Inhaled Glucocorticoids: A Pharmacokinetic/ Pharmacodynamic Perspective

S. Szefler, H. Derendorf, R. Nave, 2004, Journal of clinical pharmacology.

Pharmacokinetic and Pharmacodynamic Evaluation of Triamcinolone Acetonide After Intravenous, Oral, and Inhaled Administration

H. Möllmann, J. Barth, H. Derendorf, 1995, Journal of clinical pharmacology.

Population Pharmacokinetic Model for a Novel Oral Hypoglycemic Formed In Vivo: Comparing the Use of Active Metabolite Data Alone Versus Using Data of Upstream and Downstream Metabolites

B. Habtemariam, D. Mager, Joseph R. Walker, 2012, Journal of clinical pharmacology.

Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period.

T. Peters-Strickland, S. Rohatagi, Cathy Zhao, 2016, The Journal of clinical psychiatry.

Ciclesonide Disposition and Metabolism: Pharmacokinetics, Metabolism, and Excretion in the Mouse, Rat, Rabbit, and Dog

S. R. Howell, S. Rohatagi, Lining Cai, 2006, American journal of therapeutics.

Population Pharmacokinetics and Pharmacodynamics of Ciclesonide

J. Barrett, B. Jensen, R. Nave, 2003, Journal of clinical pharmacology.

Dependency of Cortisol Suppression on the Administration Time of Inhaled Corticosteroids

B. Meibohm, H. Möllmann, J. Barth, 1997, Journal of clinical pharmacology.

Mathematical modeling of cortisol circadian rhythm and cortisol suppression

H. Derendorf, S. Rohatagi, A. Bye, 1996 .

Protein Binding and Its Potential for Eliciting Minimal Systemic Side Effects with a Novel Inhaled Corticosteroid, Ciclesonide

R. Nave, S. Rohatagi, S. P. King, 2005, American journal of therapeutics.

Ciclesonide, a novel inhaled steroid, has no effect on hypothalamic-pituitary-adrenal (HPA)-axis function in mild-to-moderate asthmatics*

S. Rohatagi, C. Laforce, D. Banerji, 2003 .

High doses of the novel inhaled steroid ciclesonide have no effect on HPA-axis function in patients with moderate-to-severe persistent asthma

S. Szefler, S. Rohatagi, D. Banerji, 2003 .

Pressor Response to Tyramine after Single 24‐Hour Application of a Selegiline Transdermal System in Healthy Males

J. Barrett, A. Azzaro, S. Rohatagi, 1997, Journal of clinical pharmacology.

Characterisation of exposure versus response of edoxaban in patients undergoing total hip replacement surgery.

H. Kastrissios, S. Rohatagi, J. Mendell, 2012, Thrombosis and haemostasis.

Pharmacological Modulation of Peripheral T and B Lymphocytes by a Selective Sphingosine 1‐Phosphate Receptor‐1 Modulator

J. Moberly, S. Rohatagi, K. Truitt, 2012, Journal of clinical pharmacology.

Model‐Supported Development of CS‐8635: A Fixed‐Dose Combination of Olmesartan, Amlodipine, and Hydrochlorothiazide

Raymond Miller, Helen Moore, S. Rohatagi, 2013, Clinical pharmacology in drug development.

PK/PD of inhaled corticosteroids: The risk/benefit of inhaled ciclesonide

H. Derendorf, R. Nave, S. Rohatagi, 2003 .

Absolute Oral Versus Inhaled Bioavailability: Significance for Inhaled Drugs with Special Reference to Inhaled Glucocorticoids

G. Rhodes, P. Chaikin, S. Rohatagi, 1999, Journal of clinical pharmacology.

Effect of Food on Pharmacokinetics of an Inhaled Drug: A Case Study with a VLA‐4 Antagonist, HMR1031

B. Jensen, S. Rohatagi, B. Shah, 2003, Journal of clinical pharmacology.

Pharmacokinetic/Pharmacodynamic Evaluation of Deflazacort in Comparison to Methylprednisolone and Prednisolone

H. Möllmann, J. Barth, H. Derendorf, 1995, Pharmaceutical Research.

A Double‐Blind, Placebo‐Controlled Study of the Efficacy and Safety of Ebastine 20 mg Once Daily Given with and without Food in the Treatment of Seasonal Allergic Rhinitis

F. Hampel, S. Rohatagi, M. Gillen, 2002, Journal of clinical pharmacology.

Absorption and Presystemic Metabolism of Selegiline Hydrochloride at Different Regions in the Gastrointestinal Tract in Healthy Males

J. Barrett, S. Rohatagi, P. Szego, 1996, Pharmaceutical Research.

Ciclesonide, a novel inhaled steroid, does not affect hypothalamic-pituitary-adrenal axis function in patients with moderate-to-severe persistent asthma.

S. Szefler, S. Rohatagi, D. Banerji, 2005, Chest.

Is a Thorough QTc Study Necessary? The Role of Modeling and Simulation in Evaluating the QTc Prolongation Potential of Drugs

S. Rohatagi, Shashank Rohatagi, Timothy J Carrothers, 2009, Journal of clinical pharmacology.

Pharmacokinetics and Concentration‐Effect Analysis of Intravenous RGD891, a Platelet GPIIb/IIIa Antagonist, Using Mixed‐Effects Modeling (NONMEM)

B. Jensen, G. Rhodes, S. Rohatagi, 2000, Journal of clinical pharmacology.

Pharmacokinetics, Pharmacodynamics, and Safety of a Platelet GPIIb/IIIa Antagonist, RGD891, following Intravenous Administration in Healthy Male Volunteers

B. Jensen, S. Rohatagi, P. Zannikos, 2000, Journal of clinical pharmacology.

Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients with Hypertension

D. Blowey, J. Blumer, J. Sullivan, 2012, Pediatric Drugs.

Pharmacokinetics of olmesartan medoxomil in pediatric patients with hypertension.

D. Blowey, J. Blumer, J. Sullivan, 2012, Paediatric drugs.

The Use of Modeling and Simulation to Guide Clinical Development of Olmesartan Medoxomil in Pediatric Subjects

D. R. Wada, S. Rohatagi, D. Salazar, 2012, Clinical pharmacology and therapeutics.

Selegiline Percutaneous Absorption in Various Species and Metabolism by Human Skin

L. J. McDonald, J. Barrett, S. Rohatagi, 2004, Pharmaceutical Research.

Critical period for a teratogenic VLA-4 antagonist: Developmental effects and comparison of embryo drug concentrations of teratogenic and non-teratogenic VLA-4 antagonists.

P. Lockey, T. Hofmann, R. Clark, 2004, Birth defects research. Part B, Developmental and reproductive toxicology.

Pharmacokinetics, Pharmacodynamics, and Safety of a Lipid-Lowering Adenosine A1 Agonist, RPR749, in Healthy Subjects

B. Jensen, S. Rohatagi, C. Natarajan, 2004, American journal of therapeutics.

Pharmacokinetics, Pharmacodynamics, and Safety of Inhaled Cyclosporin A (ADI628) after Single and Repeated Administration in Healthy Male and Female Subjects and Asthmatic Patients

B. Jensen, S. Rohatagi, S. Kirkesseli, 2000, Journal of clinical pharmacology.

PHARMACOKINETICS OF IPRIFLAVONE AND METABOLITES AFTER ORAL ADMINISTRATION OF A CORN‐OIL SUSPENSION RELATIVE

K. Yu, J. Barrett, S. Rohatagi, 1997, American journal of therapeutics.

PHARMACOKINETICS AND SAFETY OF A SELEGILINE TRANSDERMAL SYSTEM RELATIVE TO SINGLE‐DOSE ORAL ADMINISTRATION IN THE ELDERLY

J. Barrett, S. Rohatagi, R. Morales, 1996, American journal of therapeutics.

Pharmacokinetics/Pharmacodynamics in Drug Development: An Industrial Perspective

R Bruno, G. Rhodes, P. Chaikin, 2000, Journal of clinical pharmacology.

Effect of age and gender on the pharmacokinetics of ebastine after single and repeated dosing in healthy subjects.

B. Jensen, G. Rhodes, S. Rohatagi, 2001, International journal of clinical pharmacology and therapeutics.

INTEGRATED PHARMACOKINETIC AND METABOLIC MODELING OF IPRIFLAVONE AND METABOLITES AFTER ORAL ADMINISTRATION

J. Barrett, S. Rohatagi, 1997, American journal of therapeutics.

Inhibition of platelet aggregation with prasugrel and clopidogrel: An integrated analysis in 846 subjects

K. Winters, J. Jakubowski, J. Brandt, 2009, Platelets.

Population Exposure‐Response Modeling of Metformin in Patients With Type 2 Diabetes Mellitus

B. Habtemariam, D. Mager, S. Schwartz, 2008, Journal of clinical pharmacology.

Development of a Predictive Pharmacokinetic Model for a Novel Cyclooxygenase‐2 Inhibitor

J. Moberly, H. Kastrissios, S. Rohatagi, 2006, Journal of clinical pharmacology.

Development and application of an aggregate adherence metric derived from population pharmacokinetics to inform clinical trial enrichment

J. Knights, S. Rohatagi, 2015, Journal of Pharmacokinetics and Pharmacodynamics.

The Effect of Dosing Regimen and Food on the Bioavailability of the Extensively Metabolized, Highly Variable Drug Eldepryl(®) (Selegiline Hydrochloride).

J. Barrett, S. Rohatagi, A. Disanto, 1996, American Journal of Therapeutics.

Model-Based Covariate Pharmacokinetic Analysis and Lack of Cortisol Suppression by the New Inhaled Corticosteroid Ciclesonide Using a Novel Cortisol Release Model

S. Sahasranaman, M. Pfister, S. Rohatagi, 2005, American journal of therapeutics.

Evaluation of Population Pharmacokinetics and Exposure‐Response Relationship With Coadministration of Amlodipine Besylate and Olmesartan Medoxomil

S. Rohatagi, D. Salazar, James Lee, 2008, Journal of clinical pharmacology.

Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole

P. Weiden, R. Baker, T. Peters-Strickland, 2016, Neuropsychiatric disease and treatment.

Bioequivalence of Selegiline HCL: Guidance for a “Highly Variable” Drug

J. Barrett, S. Rohatagi, R. Morales, 1996 .

Mass Balance Study of [14C]M100240, a Dual Angiotensin-Converting Enzyme/Neutral Endopeptidase Inhibitor, in Healthy Male Subjects

B. Jensen, S. Rohatagi, N. Martin, 2003, American journal of therapeutics.

Are there lessons to be learned from drug development that will accelerate the use of molecular imaging probes in the clinic?

K. Krohn, W. Eckelman, D. Vera, 2005, Nuclear medicine and biology.

Model‐Based Development of a PPARγ Agonist, Rivoglitazone, to Aid Dose Selection and Optimize Clinical Trial Designs

Jin Y. Jin, W. Jusko, S. Rohatagi, 2008, Journal of clinical pharmacology.

In Vitro and In Vivo Techniques Used in Drug Development for Evaluation of Dose Delivery of Inhaled Corticosteroids

G. Rhodes, P. Chaikin, S. Rohatagi, 2001, Journal of clinical pharmacology.

Predictive Population Pharmacokinetic/Pharmacodynamic Model for a Novel COX‐2 Inhibitor

K. Yoshihara, J. Moberly, H. Kastrissios, 2007, Journal of clinical pharmacology.