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View article: Representation of Older Adult Patients in Clinical Trials
Representation of Older Adult Patients in Clinical Trials Open
Older adults remain significantly underrepresented in clinical trials. This is concerning because age‐associated physiological changes can alter drug pharmacokinetics and pharmacodynamics. This paper examines the status of older adult repr…
View article: The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference
The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference Open
At the 6th International Conference of the Global Bioequivalence Harmonisation Initiative (GBHI), co-organised by the European Federation of Pharmaceutical Sciences (EUFEPS) and the Product Quality Research Institute (PQRI), critical bioeq…
View article: Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program
Considerations for Industry—Preparing for the FDA Model‐Informed Drug Development (MIDD) Paired Meeting Program Open
A recent industry perspective published in this journal describes the benefits received by drug companies from participation in the MIDD Pilot Program. Along with the primary objectives of supporting good decision‐making in drug developmen…
View article: Ensuring diversity in clinical trials: The role of clinical pharmacology
Ensuring diversity in clinical trials: The role of clinical pharmacology Open
Increasing the diversity of participants in clinical trials is important as it allows further examination of drug effects in all subgroups of patients who will be prescribed an approved medicine. It also gives patients more confidence in t…
View article: Clinical Relevance of Hepatic and Renal P‐gp/<scp>BCRP</scp> Inhibition of Drugs: An International Transporter Consortium Perspective
Clinical Relevance of Hepatic and Renal P‐gp/<span>BCRP</span> Inhibition of Drugs: An International Transporter Consortium Perspective Open
The role of P‐glycoprotein (P‐gp) and breast cancer resistance protein (BCRP) in drug–drug interactions (DDIs) and limiting drug absorption as well as restricting the brain penetration of drugs with certain physicochemical properties is we…
View article: Exposure‐Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies
Exposure‐Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies Open
Tofacitinib is an oral small molecule JAK inhibitor for the treatment of ulcerative colitis. Relationships between plasma tofacitinib concentration and efficacy were characterized using exposure‐response (E‐R) models, with demographic and …
View article: To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias
To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias Open
An IQ consortium working group (WG) conducted a survey across multiple biopharmaceutical companies to gain information about the level of blinding commonly utilized for early clinical development trials. The main objectives were: (1) to un…
View article: Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program
Industrial Perspective on the Benefits Realized From the FDA’s Model‐Informed Drug Development Paired Meeting Pilot Program Open
The US Food and Drug Administration (FDA) Model-Informed Drug Development (MIDD) Paired Meeting Pilot Program was created to facilitate the application of MIDD principles1 to drug development. Industry has actively participated in this opp…
View article: Regarding Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018
Regarding Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018 Open
We wish to congratulate Tanaudommongkon et al. on demonstrating the success of a pathway to expedite labeling for pediatric patients.1 We also advocate including children in trials supporting the initial submission. Yet, there is further o…
View article: Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy
Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy Open
Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in which the characteristics of each patient are considered as opposed to applying a one-size-fits-all alternative. This …
View article: The Weight of Evidence From Electrophysiology, Observational, and Cardiovascular End Point Studies Demonstrates the Safety of Azithromycin
The Weight of Evidence From Electrophysiology, Observational, and Cardiovascular End Point Studies Demonstrates the Safety of Azithromycin Open
Increased use of azithromycin (AZ) in treating infections associated with coronavirus disease 2019 (COVID‐19) and reports of increased incidence of prolonged corrected QT (QTc) interval associated with AZ used with hydroxychloroquine promp…
View article: Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID‐19 Infection
Pharmacokinetics and Pharmacological Properties of Chloroquine and Hydroxychloroquine in the Context of COVID‐19 Infection Open
Chloroquine and hydroxychloroquine are quinoline derivatives used to treat malaria. To date, these medications are not approved for the treatment of viral infections, and there are no well‐controlled, prospective, randomized clinical studi…
View article: Drug Dosing Recommendations for All Patients: A Roadmap for Change
Drug Dosing Recommendations for All Patients: A Roadmap for Change Open
Most drug labels do not contain dosing recommendations for a significant portion of real‐world patients for whom the drug is prescribed. Current label recommendations predominately reflect the population studied in pivotal trials that typi…
View article: A Real‐World Evidence Framework for Optimizing Dosing in All Patients With COVID‐19
A Real‐World Evidence Framework for Optimizing Dosing in All Patients With COVID‐19 Open
Potential treatments for coronavirus disease 2019 (COVID‐19) are being investigated at unprecedented speed, and successful treatments will rapidly be used in tens or hundreds of thousands of patients. To ensure safe and effective use in al…
View article: ITC Commentary on Metformin Clinical Drug–Drug Interaction Study Design That Enables an Efficacy‐ and Safety‐Based Dose Adjustment Decision
ITC Commentary on Metformin Clinical Drug–Drug Interaction Study Design That Enables an Efficacy‐ and Safety‐Based Dose Adjustment Decision Open
Metformin drug-drug interaction (DDI) studies are conducted during development of drugs that inhibit organic cation transporters and/or multidrug and toxin extrusion proteins (OCTs/MATEs). Monitoring solely changes in systemic exposure, th…
View article: Why Has Model‐Informed Precision Dosing Not Yet Become Common Clinical Reality? Lessons From the Past and a Roadmap for the Future
Why Has Model‐Informed Precision Dosing Not Yet Become Common Clinical Reality? Lessons From the Past and a Roadmap for the Future Open
Patient groups prone to polypharmacy and special subpopulations are susceptible to suboptimal treatment. Refined dosing in special populations is imperative to improve therapeutic response and/or lowering the risk of toxicity. Model‐inform…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: A proposal for scientific framework enabling specific population drug dosing recommendations
A proposal for scientific framework enabling specific population drug dosing recommendations Open
Over the last 3 decades, there has been little change in the paradigm to derive dosing recommendations for specific populations (e.g., renal failure, elderly, or obese patients) despite better understanding of clearance pathways in these g…
View article: Fabrication of microporous templates for use in Supercritical Fluid Electrodeposition (SCFED)
Fabrication of microporous templates for use in Supercritical Fluid Electrodeposition (SCFED) Open
This thesis described the development of microporous and mesoporous templates for use as nanowire deposition templates in Supercritical Fluid Electrodeposition (SCFED) as part of an EPSRC funded project.This project was focussed in 3 areas…
View article: Impact of Discordance Among Regulations for Biopharmaceutics Classification System-Based Waivers of Clinical Bioequivalence Studies
Impact of Discordance Among Regulations for Biopharmaceutics Classification System-Based Waivers of Clinical Bioequivalence Studies Open
Approximately 10 years ago, the FDA issued a guidance whereby dissolution could be used to establish bioequivalence for highly soluble and highly permeable immediate-release products.This pathway has advantages in lower costs for pharmaceu…