Access the full text.
Sign up today, get DeepDyve free for 14 days.
N. Mathias, Yan Xu, B. Vig, Umesh Kestur, Amy Saari, J. Crison, D. Desai, Aditya Vanarase, M. Hussain (2015)
Food Effect in Humans: Predicting the Risk Through In Vitro Dissolution and In Vivo Pharmacokinetic ModelsThe AAPS Journal, 17
L. Greenhill, J. Swanson, Kenneth Steinhoff, J. Fried, K. Posner, M. Lerner, S. Wigal, S. Clausen, Yuxin Zhang, S. Tulloch (2003)
A pharmacokinetic/pharmacodynamic study comparing a single morning dose of adderall to twice-daily dosing in children with ADHD.Journal of the American Academy of Child and Adolescent Psychiatry, 42 10
From key success factors to key success loops. The systems thinker
Wei Chen, D. Desai, D. Good, J. Crison, Peter Timmins, S. Paruchuri, J. Wang, K. Ha (2015)
Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet FormulationAAPS PharmSciTech, 17
N. Holford (2015)
Clinical pharmacology = disease progression + drug actionBritish Journal of Clinical Pharmacology, 79
S. Choy, E. Hénin, J. Walt, M. Kjellsson, M. Karlsson (2013)
Identification of the primary mechanism of action of an insulin secretagogue from meal test data in healthy volunteers based on an integrated glucose-insulin modelJournal of Pharmacokinetics and Pharmacodynamics, 40
Boyang Zhang, A. Korolj, B. Lai, M. Radisic (2018)
Advances in organ-on-a-chip engineeringNature Reviews Materials, 3
Laura Guilhoto, Laura Guilhoto, Laura Guilhoto, T. Loddenkemper, M. Vendrame, M. Vendrame, A. Bergin, B. Bourgeois, S. Kothare (2011)
Higher evening antiepileptic drug dose for nocturnal and early-morning seizuresEpilepsy & Behavior, 20
Susan Ferreira, Misagh Faezipour (2012)
Advancing the Development of Systems Engineers Using Process Simulators
J. Ford, N. Schmitt, Suzanne Schechtman, Brian Hults, Mary Doherty (1989)
Process tracing methods: Contributions, problems, and neglected research questionsOrganizational Behavior and Human Decision Processes, 43
S. Marshall, R. Burghaus, V. Cosson, S. Cheung, M. Chenel, O. DellaPasqua, N. Frey, B. Hamrén, L. Harnisch, F. Ivanow, T. Kerbusch, J. Lippert, P. Milligan, S. Rohou, A. Staab, J. Steimer, C. Tornøe, Sag Visser (2016)
Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and DocumentationCPT: Pharmacometrics & Systems Pharmacology, 5
(2017)
Applying the Biopharmaceutics Risk Assessment Roadmap (BioRAM): Patient-Focused Drug Development: Developing critical knowledge with BioRAM and the BioRAM Scoring Grid
J. Dunne, W. Rodriguez, M. Murphy, B. Beasley, G. Burckart, J. Filie, L. Lewis, H. Sachs, P. Sheridan, Peter Starke, L. Yao (2011)
Extrapolation of Adult Data and Other Data in Pediatric Drug-Development ProgramsPediatrics, 128
Christel Bergström, R. Holm, Søren Jørgensen, Sara Andersson, P. Artursson, S. Beato, Anders Borde, K. Box, M. Brewster, J. Dressman, Kung-I Feng, G. Halbert, E. Kostewicz, M. McAllister, U. Muenster, Julian Thinnes, Robert Taylor, A. Mullertz (2014)
Early pharmaceutical profiling to predict oral drug absorption: current status and unmet needs.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 57
A. Selen, Maria Cruañes, A. Müllertz, P. Dickinson, J. Cook, J. Polli, F. Kesisoglou, J. Crison, Kevin Johnson, Gordon Muirhead, T. Schofield, Y. Tsong (2010)
Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient BenefitThe AAPS Journal, 12
K. Maani, V. Maharaj (2004)
Links between systems thinking and complex decision makingSystem Dynamics Review, 20
A. Hirakawa, J. Asano, Hiroyuki Sato, S. Teramukai (2018)
Master protocol trials in oncology: Review and new trial designsContemporary Clinical Trials Communications, 12
I. Mahmood, M. Green (2005)
Pharmacokinetic and Pharmacodynamic Considerations in the Development of Therapeutic ProteinsClinical Pharmacokinetics, 44
(2000)
n d modeling-understanding change and complexity
L. Beach, T. Mitchell (1978)
A Contingency Model for the Selection of Decision StrategiesAcademy of Management Review, 3
Shaji Kumar, V. Rajkumar, R. Kyle, M. Duin, P. Sonneveld, M. Mateos, F. Gay, K. Anderson (2017)
Multiple myelomaNature Reviews Disease Primers, 3
(2016)
Open access/BioRAM-based decis ions/AAPS. AAPS webinar archive: https
T. Wilens, T. Spencer (2010)
Understanding Attention-Deficit/Hyperactivity Disorder from Childhood to AdulthoodPostgraduate Medicine, 122
B. Munos (2009)
Lessons from 60 years of pharmaceutical innovationNature Reviews Drug Discovery, 8
D. Peters (2014)
The application of systems thinking in health: why use systems thinking?Health Research Policy and Systems, 12
Manisha Lamba, M. Hutmacher, Daniel Furst, A. Dikranian, M. Dowty, Daniela Conrado, Thomas Stock, C. Nduaka, Jack Cook, S. Krishnaswami (2017)
Model‐Informed Development and Registration of a Once‐Daily Regimen of Extended‐Release TofacitinibClinical Pharmacology and Therapeutics, 101
M. Herbrink, B. Nuijen, J. Schellens, J. Beijnen (2015)
Variability in bioavailability of small molecular tyrosine kinase inhibitors.Cancer treatment reviews, 41 5
N. Holford, L. Sheiner (1982)
Kinetics of pharmacologic response.Pharmacology & therapeutics, 16 2
T. DesRochers, Erica Palma, D. Kaplan (2014)
Tissue-engineered kidney disease models.Advanced drug delivery reviews, 69-70
E. Kostewicz, B. Abrahamsson, M. Brewster, J. Brouwers, J. Butler, Sara Carlert, P. Dickinson, J. Dressman, R. Holm, S. Klein, J. Mann, M. McAllister, M. Minekus, U. Muenster, A. Müllertz, M. Verwei, M. Vertzoni, W. Weitschies, P. Augustijns (2014)
In vitro models for the prediction of in vivo performance of oral dosage forms.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 57
Lawrence Yu, E. Lipka, J. Crison, G. Amidon (1996)
Transport approaches to the biopharmaceutical design of oral drug delivery systems: prediction of intestinal absorption.Advanced drug delivery reviews, 19 3
G. Amidon, H. Lennernäs, V. Shah, J. Crison (1995)
A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo BioavailabilityPharmaceutical Research, 12
H. Lennernäs, J. Crison, G. Amidon (1995)
Permeability and clearance views of drug absorption: A commentaryJournal of Pharmacokinetics and Biopharmaceutics, 23
F. Kesisoglou, Andre Hermans, C. Neu, K. Yee, J. Palcza, Jessica Miller (2015)
Development of In Vitro-In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls.Journal of pharmaceutical sciences, 104 9
Anushua Sinha (2002)
Decision Making in Health and Medicine: Integrating Evidence and ValuesJournal of the Royal Society of Medicine, 95
S. Paul, D. Mytelka, C. Dunwiddie, Charles Persinger, B. Munos, S. Lindborg, A. Schacht (2010)
How to improve R&D productivity: the pharmaceutical industry's grand challengeNature Reviews Drug Discovery, 9
Sonia Iurian, Luana Turdean, I. Tomuțǎ (2017)
Risk assessment and experimental design in the development of a prolonged release drug delivery system with paliperidoneDrug Design, Development and Therapy, 11
(2011)
Leadership and Creativity
P. Senge (1991)
The fifth discipline : the art and practice of the learning organization/ Peter M. Senge
Andrew McGuire, S. Mosbach, Kok Lee, Gavin Reynolds, M. Kraft (2018)
A high-dimensional, stochastic model for twin-screw granulation – Part 1: Model descriptionChemical Engineering Science
M. Frank (2012)
Engineering Systems Thinking: Cognitive Competencies of Successful Systems Engineers
M. Summar, D. Dobbelaere, S. Brusilow, Brendan Lee (2008)
Diagnosis, symptoms, frequency and mortality of 260 patients with urea cycle disorders from a 21‐year, multicentre study of acute hyperammonaemic episodesActa Pædiatrica, 97
P. Pandey, R. Hamey, D. Bindra, Zongyun Huang, N. Mathias, T. Eley, J. Crison, B. Yan, R. Perrone, Chandra Vemavarapu (2014)
From Bench to Humans: Formulation Development of a Poorly Water Soluble Drug to Mitigate Food EffectAAPS PharmSciTech, 15
S. Rajkumar (2018)
Multiple myeloma: 2018 update on diagnosis, risk‐stratification, and managementAmerican Journal of Hematology, 93
Yanguang Cao, J. Balthasar, W. Jusko (2013)
Second-generation minimal physiologically-based pharmacokinetic model for monoclonal antibodiesJournal of Pharmacokinetics and Pharmacodynamics, 40
W. Jusko (2013)
Moving from basic toward systems pharmacodynamic models.Journal of pharmaceutical sciences, 102 9
J. Crison, P. Timmins, A. Keung, V. Upreti, D. Boulton, B. Scheer (2012)
Biowaiver approach for biopharmaceutics classification system class 3 compound metformin hydrochloride using in silico modeling.Journal of pharmaceutical sciences, 101 5
M. Finer, J. Glorioso (2017)
A brief account of viral vectors and their promise for gene therapyGene Therapy, 24
F. Kesisoglou, John Chung, J. Asperen, T. Heimbach (2016)
Physiologically Based Absorption Modeling to Impact Biopharmaceutics and Formulation Strategies in Drug Development-Industry Case Studies.Journal of pharmaceutical sciences, 105 9
K. Schenk, N. Vitalari, K. Davis (1998)
Differences Between Novice and Expert Systems Analysts: What Do We Know and What Do We Do?J. Manag. Inf. Syst., 15
D. Murray, R. Bussing, M. Fernandez, W. Hou, C. Garvan, J. Swanson, S. Eyberg (2009)
Psychometric Properties of Teacher SKAMP Ratings From a Community SampleAssessment, 16
Morris Brown, C. Toal (2008)
Formulation of long-acting nifedipine tablets influences the heart rate and sympathetic nervous system response in hypertensive patients.British journal of clinical pharmacology, 65 5
V. Shakhnovich, S. Abdel‐Rahman (2014)
General Considerations for Pediatric Oral Drug Formulation, 11
S. Pathak, Aaron Ruff, E. Kostewicz, N. Patel, D. Turner, M. Jamei (2017)
Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug.Molecular pharmaceutics, 14 12
J. Butler, J. Dressman (2010)
The developability classification system: application of biopharmaceutics concepts to formulation development.Journal of pharmaceutical sciences, 99 12
Steven Cavaleri, J. Sterman (1997)
Towards evaluation of systems‐thinking interventions: a case studySystem Dynamics Review, 13
D. Swinney (2013)
Phenotypic vs. Target‐Based Drug Discovery for First‐in‐Class MedicinesClinical Pharmacology & Therapeutics, 93
A. Willemsen, Floor Lubberman, J. Tol, W. Gerritsen, C. Herpen, N. Erp (2016)
Effect of food and acid-reducing agents on the absorption of oral targeted therapies in solid tumors.Drug discovery today, 21 6
T. Strine, C. Lesesne, C. Okoro, L. Mcguire, D. Chapman, L. Balluz, A. Mokdad (2006)
Emotional and Behavioral Difficulties and Impairments in Everyday Functioning Among Children With a History of Attention-Deficit/Hyperactivity DisorderPreventing Chronic Disease, 3
L. Sheiner (1997)
Learning versus confirming in clinical drug developmentClinical Pharmacology & Therapeutics, 61
J. Swanson, Suneel Gupta, D. Guinta, D. Flynn, D. Agler, M. Lerner, Lillie Williams, I. Shoulson, S. Wigal (1999)
Acute tolerance to methylphenidate in the treatment of attention deficit hyperactivity disorder in childrenClinical Pharmacology & Therapeutics, 66
E. Gamsiz, M. Ashtikar, J. Crison, W. Woltosz, M. Bolger, R. Carrier (2010)
Predicting the Effect of Fed-State Intestinal Contents on Drug DissolutionPharmaceutical Research, 27
S. Sarac, C. Rasmussen, Morten Rasmussen, Christine Hallgreen, T. Søeborg, M. Colding‐Jørgensen, Per Christensen, S. Thirstrup, E. Mosekilde (2012)
A Comprehensive Approach to Benefit–Risk Assessment in Drug DevelopmentBasic & Clinical Pharmacology & Toxicology, 111
M. Nguyen, T. Flanagan, M. Brewster, F. Kesisoglou, S. Beato, J. Biewenga, J. Crison, R. Holm, R. Li, E. Mannaert, M. McAllister, M. Mueller-Zsigmondy, U. Muenster, K. Ojala, S. Page, A. Parr, S. Rossenu, P. Timmins, A. Peer, A. Vermeulen, P. Langguth (2017)
A survey on IVIVC/IVIVR development in the pharmaceutical industry – Past experience and current perspectivesEuropean Journal of Pharmaceutical Sciences, 102
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations
Roberto Gomeni, Fmm Bressolle-Gomeni, Thomas Spencer, S. Faraone, Lanyan Fang, Andrew Babiskin (2017)
Model‐Based Approach for Optimizing Study Design and Clinical Drug Performances of Extended‐Release Formulations of Methylphenidate for the Treatment of ADHDClinical Pharmacology & Therapeutics, 102
M. Berg, D. Kringos, Lisanne Marks, N. Klazinga (2014)
The Dutch health care performance report: seven years of health care performance assessment in the NetherlandsHealth Research Policy and Systems, 12
J. Sterman (1989)
Misperceptions of Feedback in a Dynamic Decision Making Experiment
A. Palumbo, K. Anderson (2011)
Multiple myeloma.The New England journal of medicine, 364 11
P. Dickinson, F. Kesisoglou, T. Flanagan, Marilyn Martinez, H. Mistry, J. Crison, J. Polli, Maria Cruañes, A. Serajuddin, A. Müllertz, J. Cook, A. Selen (2016)
Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid.Journal of pharmaceutical sciences, 105 11
M. Samtani, S. Gopal, C. Gassmann-Mayer, L. Alphs, J. Palumbo (2011)
Dosing and Switching Strategies for Paliperidone PalmitateCNS Drugs, 25
J. Sterman (1989)
Misperceptions of feedback in dynamic decision makingOrganizational Behavior and Human Decision Processes, 43
A. Krause (2008)
Pharmacometrics: The Science of Quantitative PharmacologyJournal of the American Statistical Association, 103
A. Auron, P. Brophy (2012)
Hyperammonemia in review: pathophysiology, diagnosis, and treatmentPediatric Nephrology, 27
J. Swanson (2005)
Long-acting stimulants: development and dosing.The Canadian child and adolescent psychiatry review = La revue canadienne de psychiatrie de l'enfant et de l'adolescent, 14 Supplement 1
(2017)
BioRAM: connecting the drug product with the patient -from design to optimized product
Venugopal Marasanapalle, J. Crison, K. Devarakonda, Xiaoling Li, B. Jasti (2011)
Predictive models for drugs exhibiting negative food effects based on their biopharmaceutical characteristicsDrug Development and Industrial Pharmacy, 37
(2018)
Pediatric formulations and dosage forms: application of biopharmaceutics risk assessment roadmap (BioRAM)
P. Keskinen, A. Siitonen, M. Salo (2008)
Hereditary urea cycle diseases in FinlandActa Pædiatrica, 97
B. Richmond (1993)
Systems thinking: critical thinking skills for the 1990s and beyondSystem Dynamics Review, 9
L. Lesko (2007)
Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?Clinical Pharmacology & Therapeutics, 81
A. Jekunen (2014)
Decision-making in product portfolios of pharmaceutical research and development – managing streams of innovation in highly regulated marketsDrug Design, Development and Therapy, 8
N. Mathias, J. Crison (2012)
The Use of Modeling Tools to Drive Efficient Oral Product DesignThe AAPS Journal, 14
K. Benam, S. Dauth, Bryan Hassell, A. Herland, A. Jain, Kyung-Jin Jang, K. Karalis, Hyun Kim, L. Macqueen, R. Mahmoodian, Samira Musah, Y. Torisawa, A. Meer, Remi Villenave, Moran Yadid, K. Parker, D. Ingber (2015)
Engineered in vitro disease models.Annual review of pathology, 10
J. Sterman (2002)
System Dynamics: Systems Thinking and Modeling for a Complex World
(2015)
Integration of biopharmaceutics and quality by design: the biopharmaceutics risk assessment road map (BioRAM) building in clinical relevance for the patient benefit
R2): Guidance for industry, pharmaceutical development, Revision 2
S. Mignani, S. Huber, H. Tomás, João Rodrigues, J. Majoral (2016)
Why and how have drug discovery strategies in pharma changed? What are the new mindsets?Drug discovery today, 21 2
Journal of Health Economics
S. Wigal, L. Greenhill, E. Nordbrock, D. Connor, S. Kollins, A. Adjei, A. Childress, A. Stehli, R. Kupper (2014)
A randomized placebo-controlled double-blind study evaluating the time course of response to methylphenidate hydrochloride extended-release capsules in children with attention-deficit/hyperactivity disorder.Journal of child and adolescent psychopharmacology, 24 10
D. Good, Ruiling Hartley, N. Mathias, J. Crison, G. Tirucherai, P. Timmins, M. Hussain, Raja Haddadin, O. Koo, F. Nikfar, Nga Fung (2015)
Mitigation of Adverse Clinical Events of a Narrow Target Therapeutic Index Compound through Modified Release Formulation Design: An in Vitro, in Vivo, in Silico, and Clinical Pharmacokinetic Analysis.Molecular pharmaceutics, 12 12
Wendy Smith, P. Kishnani, Brendan Lee, Rani Singh, W. Rhead, Lisa King, Michael Smith, M. Summar (2005)
Urea cycle disorders: clinical presentation outside the newborn period.Critical care clinics, 21 4 Suppl
Ross Arnold, J. Wade (2017)
A Complete Set of Systems Thinking SkillsINCOSE International Symposium, 27
R. Atun (2012)
Health systems, systems thinking and innovation.Health policy and planning, 27 Suppl 4
P. Todd, I. Benbasat (1987)
Process Tracing Methods in Decision Support Systems Research: Exploring the Black BoxMIS Q., 11
K. Allegaert, S. Simons, D. Tibboel, E. Krekels, C. Knibbe, J. Anker (2017)
Non‐maturational covariates for dynamic systems pharmacology models in neonates, infants, and children: Filling the gaps beyond developmental pharmacologyEuropean Journal of Pharmaceutical Sciences, 109
S. Patterson (2010)
Experiences with Learning and Confirming in Drug and Biological DevelopmentClinical Pharmacology & Therapeutics, 88
A. Selen, P. Dickinson, A. Müllertz, J. Crison, H. Mistry, Maria Cruañes, Marilyn Martinez, H. Lennernäs, T. Wigal, D. Swinney, J. Polli, A. Serajuddin, J. Cook, J. Dressman (2014)
The biopharmaceutics risk assessment roadmap for optimizing clinical drug product performance.Journal of pharmaceutical sciences, 103 11
R. Gomeni, Françoise Bressolle‐Gomeni, M. Fava (2016)
Response Surface Analysis and Nonlinear Optimization Algorithm for Maximization of Clinical Drug Performance: Application to Extended‐Release and Long‐Acting Injectable PaliperidoneThe Journal of Clinical Pharmacology, 56
M. Herbrink, J. Schellens, J. Beijnen, B. Nuijen (2016)
Inherent formulation issues of kinase inhibitors.Journal of controlled release : official journal of the Controlled Release Society, 239
Jennifer Chatman, K. Jehn (1994)
Assessing the Relationship between Industry Characteristics and Organizational Culture: How Different can You Be?Academy of Management Journal, 37
I. Androulakis (2016)
Quantitative Systems Pharmacology: A Framework for ContextCurrent Pharmacology Reports, 2
Jack Cook, Maria Cruañes, Manish Gupta, S. Riley, J. Crison (2013)
Quality-by-Design: Are We There Yet?AAPS PharmSciTech, 15
L. Lesko (2018)
Efficacy From Strange SourcesClinical Pharmacology & Therapeutics, 103
Ana Gago, Gavin Reynolds, P. Kleinebudde (2017)
Impact of roll compactor scale on ribbon densityPowder Technology
G. Tan (1998)
Managing Creativity in Organizations: a Total System ApproachCreativity and Innovation Management, 7
G. Raju, Karthik Gurumurthi, Reuben Domike, D. Kazandjian, O. Landgren, G. Blumenthal, A. Farrell, R. Pazdur, J. Woodcock (2018)
A Benefit–Risk Analysis Approach to Capture Regulatory Decision‐Making: Multiple MyelomaClinical Pharmacology & Therapeutics, 103
X. Zhang, J. Duan, F. Kesisoglou, J. Novakovic, G. Amidon, M. Jamei, V. Lukacova, T. Eissing, E. Tsakalozou, L. Zhao, R. Lionberger (2017)
Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public WorkshopCPT: Pharmacometrics & Systems Pharmacology, 6
Chapter 31: systems thinking, part 5: knowledge transdisciplined. The Oxford handbook of interdisciplinarity
Andre Hermans, Andreas Abend, F. Kesisoglou, T. Flanagan, Michael Cohen, D. Diaz, Yun Mao, Limin Zhang, G. Webster, Yiqing Lin, David Hahn, Carrie Coutant, H. Grady (2017)
Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage FormsThe AAPS Journal, 19
M. Waszak, K.M.f Jones, R. Nowaczyk (2004)
Modeling and Analvsis of MultidisEipline Regearch Teams at NASA Langley Research Center: A Systems Thinking Approach
Jonathan Brown, J. Crison, P. Timmins (2012)
Predicting feasibility and characterizing performance of extended-release formulations using physiologically based pharmacokinetic modeling.Therapeutic delivery, 3 9
P. Byass (2011)
Systems thinking for health systems strengtheningPublic Health, 125
J. Swanson, L. Hechtman (2005)
Using long-acting stimulants: does it change ADHD treatment outcome?The Canadian child and adolescent psychiatry review = La revue canadienne de psychiatrie de l'enfant et de l'adolescent, 14 Supplement 1
Holly Kimko, J. Pinheiro (2015)
Model‐based clinical drug development in the past, present and future: a commentaryBritish Journal of Clinical Pharmacology, 79
E. Martins, F. Terblanche (2003)
Building organisational culture that stimulates creativity and innovationEuropean Journal of Innovation Management, 6
J. Arrowsmith, Philip Miller (2013)
Trial Watch: Phase II and Phase III attrition rates 2011–2012Nature Reviews Drug Discovery, 12
C. Mehta, P. Gao, Deepak Bhatt, R. Harrington, S. Skerjanec, J. Ware (2009)
Optimizing Trial Design: Sequential, Adaptive, and Enrichment StrategiesCirculation, 119
R. Leeuwen, R. Peric, K. Hussaarts, E. Kienhuis, N. IJzerman, P. Bruijn, C. Leest, H. Codrington, J. Kloover, B. Holt, J. Aerts, T. Gelder, R. Mathijssen (2016)
Influence of the Acidic Beverage Cola on the Absorption of Erlotinib in Patients With Non-Small-Cell Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 34 12
S. Basavaraj, G. Betageri (2014)
Can formulation and drug delivery reduce attrition during drug discovery and development—review of feasibility, benefits and challengesActa Pharmaceutica Sinica. B, 4
Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)
E. Kostewicz, L. Aarons, M. Bergstrand, M. Bolger, A. Galetin, Oliver Hatley, M. Jamei, Richard Lloyd, X. Pepin, A. Rostami-Hodjegan, E. Sjögren, C. Tannergren, D. Turner, Christian Wagner, W. Weitschies, J. Dressman (2014)
PBPK models for the prediction of in vivo performance of oral dosage forms.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences, 57
H. Mistry, M. Fabre, J. Young, G. Clack, P. Dickinson (2016)
Systems Pharmacology Modeling of Prostate‐Specific Antigen in Patients With Prostate Cancer Treated With an Androgen Receptor Antagonist and Down‐RegulatorCPT: Pharmacometrics & Systems Pharmacology, 5
Jamie Lien, W. Nyhan, B. Barshop (2007)
Fatal initial adult-onset presentation of urea cycle defect.Archives of neurology, 64 12
G. Raju, Karthik Gurumurthi, Reuben Domike, D. Kazandjian, G. Blumenthal, R. Pazdur, Janet Woodcock (2016)
A Benefit–Risk Analysis Approach to Capture Regulatory Decision‐Making: Non‐Small Cell Lung CancerClinical Pharmacology & Therapeutics, 100
E. Rouwette, J. Vennix, T. Mullekom (2002)
Group model building effectiveness: a review of assessment studies †System Dynamics Review, 18
Decision-making in drug development benefits from an integrated systems approach, where the stakeholders identify and address the critical questions for the system through carefully designed and performed studies. Biopharmaceutics Risk Assessment Roadmap (BioRAM) is such a systems approach for application of systems thinking to patient focused and timely decision-making, suitable for all stages of drug discovery and development. We described the BioRAM therapy-driven drug delivery framework, strategic roadmap, and integrated risk assessment instrument (BioRAM Scoring Grid) in previous publications (J Pharm Sci 103:3377–97, 2014; J Pharm Sci 105:3243–55, 2016). Integration of systems thinking with pharmaceutical development, manufacturing, and clinical sciences and health care is unique to BioRAM where the developed strategy identifies the system and enables risk characterization and balancing for the entire system. Successful decision-making process in BioRAM starts with the Blueprint (BP) meetings. Through shared understanding of the system, the program strategy is developed and captured in the program BP. Here, we provide three semi-hypothetical examples for illustrating risk-based decision-making in high and moderate risk settings. In the high-risk setting, which is a rare disease area, two completely alternate development approaches are considered (gene therapy and small molecule). The two moderate-risk examples represent varied knowledge levels and drivers for the programs. In one moderate-risk example, knowledge leveraging opportunities are drawn from the manufacturing knowledge and clinical performance of a similar drug substance. In the other example, knowledge on acute tolerance patterns for a similar mechanistic pathway is utilized for identifying markers to inform the drug release profile from the dosage form with the necessary “flexibility” for dosing. All examples illustrate implementation of the BioRAM strategy for leveraging knowledge and decision-making to optimize the clinical performance of drug products for patient benefit.
"The AAPS Journal" – Springer Journals
Published: Jul 27, 2020
Read and print from thousands of top scholarly journals.
Already have an account? Log in
Bookmark this article. You can see your Bookmarks on your DeepDyve Library.
To save an article, log in first, or sign up for a DeepDyve account if you don’t already have one.
Copy and paste the desired citation format or use the link below to download a file formatted for EndNote
Access the full text.
Sign up today, get DeepDyve free for 14 days.
All DeepDyve websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.