A. Gould

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Perspectives on the Use of Data Mining in Pharmacovigilance

Joseph M. Tonning, Vaishali K. Patadia, R. Ouellet-Hellstrom, 2005, Drug safety.

The analysis of titration studies in phase III clinical trials.

A. Gould, W. Shih, I. K. Hwang, 1989, Statistics in medicine.

Safety of cefoxitin: an approach to the analysis of laboratory data.

A. Gould, K. R. Brown, A. Getson, 1979, Reviews of infectious diseases.

Sample size re-estimation without unblinding for normally distributed outcomes with unknown variance

A. Gould, W. Shih, 1992 .

Planning and revising the sample size for a trial.

A. Gould, 1995, Statistics in Medicine.

How Practical are Adaptive Designs Likely to be for Confirmatory Trials?

A. Gould, 2006, Biometrical journal. Biometrische Zeitschrift.

Phase 1 trials

A. Gould, 2014 .

Group sequential extensions of a standard bioequivalence testing procedure

A. Lawrence Gould, A. Gould, 2006, Journal of Pharmacokinetics and Biopharmaceutics.

Sample sizes for event rate equivalence trials using prior information.

A L Gould, A. Gould, 1993, Statistics in medicine.

Another view of active-controlled trials.

A L Gould, A. Gould, 1991, Controlled clinical trials.

Bayesian analysis of multicentre trial outcomes

A Lawrence Gould, A. Gould, 2005, Statistical methods in medical research.

BIOPHARMACEUTICAL STATISTICS BEYOND 2000

A. Gould, 2001, Journal of biopharmaceutical statistics.

Group sequential methods for clinical trials allowing early acceptance of Ho and incorporating costs

A. Lawrence Gould, A. Gould, V. Pecore, 1982 .

Pharmacovigilance using observational/longitudinal databases and web‐based information

A. Gould, 2014 .

Unified screening for potential elevated adverse event risk and other associations

A. Gould, 2018, Statistics in medicine.

A 1‐step Bayesian predictive approach for evaluating in vitro in vivo correlation (IVIVC)

A. Gould, S. Fitzpatrick, N. Agrawal, 2009, Biopharmaceutics & drug disposition.

A Simple Method for Testing Global and Individual Hypotheses Involving a Limited Number of Possibly Correlated Outcomes

A. Gould, 2015 .

The human lens after 48 weeks of treatment with lovastatin.

H. Taylor, C. Shear, A. Gould, 1990, The New England journal of medicine.

SELF‐DIRECTED TREATMENT OF INTERMITTENT HEARTBURN: A RANDOMIZED, MULTICENTER, DOUBLE‐BLIND, PLACEBO‐CONTROLLED EVALUATION OF ANTACID AND LOW DOSES OF AN H2-RECEPTOR ANTAGONIST (FAMOTIDINE)

A. Gould, A. Getson, R. Berlin, 1995, American journal of therapeutics.

Detecting Potential Safety Issues in Large Clinical or Observational Trials by Bayesian Screening When Event Counts Arise from Poisson Distributions

A. Gould, 2013, Journal of biopharmaceutical statistics.

Design of the DEFINE trial: determining the EFficacy and tolerability of CETP INhibition with AnacEtrapib.

A Lawrence Gould, Christopher P Cannon, Bruce Binkowitz, 2009, American heart journal.

Generating and confirming hypotheses

A. Gould, 2010, Pharmacoepidemiology and drug safety.

Meta-analysis by the Program on the Surgical Control of the Hyperlipidemias (POSCH) investigators.

A. Gould, A. T. Cariski, A. Cariski, 1998, Annals of surgery.

Monitoring potential adverse event rate differences using data from blinded trials: the canary in the coal mine

A. Gould, William W B Wang, William W. B. Wang, 2017, Statistics in medicine.

Intraocular pressure decrease in normal volunteers following timolol ophthalmic solution.

A. Gould, A. Getson, W. A. Hubbard, 1976, Investigative ophthalmology.

Congenital malformations among infants born to women receiving montelukast, inhaled corticosteroids, and other asthma medications.

M. Bamshad, J. Stoler, A. Gould, 2012, The Journal of allergy and clinical immunology.

Effects of sources of variability on sample sizes required for RCTs, applied to trials of lipid-altering therapies on carotid artery intima-media thickness

R. Pasternak, A. Gould, C. Pinto, 2009, Clinical trials.

Bayesian screening for feature selection

R. Baumgartner, A. Gould, Amanda Zhao, 2022, Journal of biopharmaceutical statistics.

Baseline differences in A1C explain apparent differences in efficacy of sitagliptin, rosiglitazone and pioglitazone

A. Gould, R. Chapell, C. M. Alexander, 2009, Diabetes, obesity & metabolism.

Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials.

A L Gould, P. Boyle, C. Roehrborn, 1996, Urology.

A Predictive Bayesian Approach to the Design and Analysis of Bridging Studies

A. Gould, William W B Wang, Tian Jin, 2012, Journal of Biopharmaceutical Statistics.

Sample sizes required for binomial trials when the true response rates are estimated

A. Gould, 1983 .

Cholesterol reduction yields clinical benefit: impact of statin trials.

N. Santanello, J. Heyse, C. Furberg, 1998, Circulation.

Cholesterol reduction yields clinical benefit. A new look at old data.

N. Santanello, J. Heyse, C. Furberg, 1995, Circulation.

Expanded Clinical Evaluation of Lovastatin (EXCEL) study results. I. Efficacy in modifying plasma lipoproteins and adverse event profile in 8245 patients with moderate hypercholesterolemia.

C. Shear, A. Gould, C. Dujovne, 1991, Archives of internal medicine.

Dexamethasone and severe head injury. A prospective double-blind study.

P. Cooper, A. Gould, J. Kirkpatrick, 1979, Journal of neurosurgery.

Treatment comparisons for a partially categorical outcome applied to a biomarker with assay limit

A. Gould, M. Nessly, Y. Joshua Chen, 2005, Statistics in medicine.

Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group

Haoda Fu, A Lawrence Gould, Theodore C Lystig, 2015, Therapeutic innovation & regulatory science.

Practical pharmacovigilance analysis strategies.

A Lawrence Gould, A. Gould, 2003, Pharmacoepidemiology and drug safety.

COMPARISON OF ALTERNATIVE STRATEGIES FOR ANALYSIS OF LONGITUDINAL TRIALS WITH DROPOUTS

A Lawrence Gould, Guanghan Liu, A. Gould, 2002, Journal of biopharmaceutical statistics.

Serum prostate-specific antigen as a predictor of prostate volume in men with benign prostatic hyperplasia.

P. Boyle, C. Roehrborn, A. Gould, 1999, Urology.

THE RELATIONSHIP BETWEEN AGE, PROSTATE VOLUME, SERUM TESTOSTERONE AND SERUM PSA IN MEN WITH CLINICAL BPH

P. Boyle, C. Roehrborn, A. Gould, 1999 .

A meta-analysis of the dose-response relationship of inhaled corticosteroids in adolescents and adults with mild to moderate persistent asthma.

J. Bousquet, A. Gould, M. Messonnier, 2002, Clinical therapeutics.

An Evaluation of Three Signal-Detection Algorithms Using a Highly Inclusive Reference Event Database

David Madigan, Manfred Hauben, A. Lawrence Gould, 2009, Drug safety.

Substantial evidence of effect

A. Gould, 2002, Journal of biopharmaceutical statistics.

Cholesterol reduction yields clinical benefits: meta-analysis including recent trials.

A. Gould, D. Yin, J. Cook, 2007, Clinical therapeutics.

Expanded clinical evaluation of lovastatin (EXCEL) study results. II. Assessment of the human lens after 48 weeks of treatment with lovastatin.

H. Taylor, C. Shear, W. P. Stephenson, 1991, The American journal of cardiology.

Modifying the design of ongoing trials without unblinding.

W J Shih, A L Gould, A. Gould, 1998, Statistics in medicine.

Timing of futility analyses for ‘proof of concept’ trials

A. Lawrence Gould, A. Gould, 2005 .

Sample size re‐estimation: recent developments and practical considerations

A L Gould, A. Gould, 2001, Statistics in medicine.

P-values for group sequential testing

A. Lawrence Gould, Steven M. Snapinn, A. Gould, 1995 .

PhRMA Perspective on Population and Individual Bioequivalence

A. Gould, J. Barrett, A. Chow, 2000, Journal of clinical pharmacology.

A practical approach for evaluating population and individual bioequivalence.

A. Gould, A. Lawrence Gould, 2000, Statistics in medicine.

Responses to discussants of ‘Joint modeling of survival and longitudinal non‐survival data: current methods and issues. report of the DIA Bayesian joint modeling working group’

Joseph G. Ibrahim, A. Lawrence Gould, George Quartey, 2015, Statistics in medicine.

Principled Structured Incorporation of Clinical Knowledge Into Strategic Development Decisions

A Lawrence Gould, Rajesh Krishna, Jeffrey Saltzman, 2015, Therapeutic innovation & regulatory science.

Interim analyses for monitoring clinical trials that do not materially affect the type I error rate.

A L Gould, A. Gould, A. Lawrence Gould, 1992, Statistics in medicine.

A framework for assessing the impact of accelerated approval

Joey Tianyi Zhou, C. Burman, J. Dey, 2022, medRxiv.

Discussion of papers of session 3: Bayes/empirical bayes

A. Lawrence Gould, A. Gould, 1992 .

Multi-centre trial analysis revisited.

A. Gould, 1998, Statistics in medicine.

An Evaluation of Computer‐Aided Disproportionality Analysis for Post‐Marketing Signal Detection

A L Gould, B E Wiholm, A. Gould, 2007, Clinical pharmacology and therapeutics.

Applying survival methodology to adverse experience occurrences in controlled clinical trials.

A. Gould, E. Bortey, 1991, Journal of biopharmaceutical statistics.

Influence of the MedDRA® hierarchy on pharmacovigilance data mining results

David Madigan, Manfred Hauben, Stephanie J. Reisinger, 2009, Int. J. Medical Informatics.

BMA‐Mod: A Bayesian model averaging strategy for determining dose‐response relationships in the presence of model uncertainty

A Lawrence Gould, A. Gould, 2018, Biometrical journal. Biometrische Zeitschrift.

Using Prior Findings to Augment Active-Controlled Trials and Trials with Small Placebo Groups

A. Gould, A., Lawrence Gould, 1991 .

Regulating High-Frequency Trading: Man V. Machine

A. Gould, Alyse L. Gould, 2012 .

A new approach to the analysis of clinical drug trials with withdrawals.

A L Gould, A. Gould, 1980, Biometrics.

Accounting for Multiplicity in the Evaluation of “Signals” Obtained by Data Mining from Spontaneous Report Adverse Event Databases

A Lawrence Gould, A. Gould, 2007, Biometrical journal. Biometrische Zeitschrift.