PubMed Journal Database | Therapeutic innovation & regulatory science RSS

19:31 EDT 18th March 2019 | BioPortfolio

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Showing PubMed Articles 1–25 of 97 from Therapeutic innovation & regulatory science

Measuring Blood Pressure in Clinical Practice: We Can and Must Do Better.

A Transitional Probability Model for Parkinson's Disease Motor States With Applications to Missing Data.

Parkinson's disease (PD) is a progressive neurodegenerative disorder with significant disability. Subjects with advanced PD often suffer from motor complications that may interfere significantly with their daily activities. Levodopa (LD) in combination with a dopa decarboxylase inhibitor such as carbidopa (CD) is considered the gold standard in the treatment of PD. However, long-term treatment with LD often leads to the development of motor complications. Motor complications include motor fluctuations and d...

Managing the Risks of Medicines: An Examination of FDA's Application of Criteria for Requiring a REMS.

In September 2016, the Food and Drug Administration (FDA) published a draft guidance for industry, FDA's Application of Statutory Factors in Determining When a REMS Is Necessary, that detailed the factors the Agency considers in determining when a Risk Evaluation and Mitigation Strategy (REMS) is necessary. The objective of this study was to determine how the FDA has applied these criteria for newly approved drugs.

Editorial Board Member's Commentary: Commissioner Scott Gottlieb's Predictable Imaginarium.

Update From the Field of Renal Sympathetic Denervation: A Focus on Safety Nomenclature Considerations.

Implications of CRISPR-Based Germline Engineering for Cancer Survivors.

Cancer survivors can carry germline mutations that will be transmitted to their progeny. Today, many of these mutations have been identified and can be tracked. With the recent development of genome-editing technologies and CRISPR (clustered regularly interspaced short palindromic repeats), the possibility of genetically modifying the human germline-gametes and embryos-has never been closer. This perspective has sparked a controversy within the scientific community with reactions ranging from calls for a ba...

Bone Mineral Density to Assess Pediatric Bone Health in Drug Development.

Pediatric bone health is an important part of the safety assessment of inhaled corticosteroids and certain other drugs. Current regulatory guidance for assessment of bone health for intranasal and inhaled corticosteroid drugs is a single 1-year study of linear growth.

The Common Pharmaceutical Market of the Eurasian Economic Union: A Regulatory Review.

According to the Treaty on the Eurasian Economic Union, a common pharmaceutical market was supposed to become operational on January 1, 2016. Nevertheless, the responsible parties did not meet the deadline. Although a majority of the draft guidelines regulating this process were already known in 2014 and 2015, the anticipated process itself caused anxiety among representatives of the foreign pharma industry, who tried to prepare for coming challenges. Among other possible issues, the ambiguity of transition...

An Innovative, Collaborative, and Strategic Approach to Proactively Evaluate and Update Drug Interactions Based on Prescribing Information of Newly Approved Medicinal Products.

Drug-drug interaction (DDIs) are evaluated using pharmacokinetic (PK) simulation models, clinical studies, and scientific publications throughout drug development. DDIs with Norvir (ritonavir) and combination products (eg, Kaletra [lopinavir/ritonavir]) containing ritonavir as a PK enhancer are relevant, because these drugs could affect exposures of CYP3A4 substrates. Application of algorithms proactively identified recently approved drugs, which potentially cause adverse outcomes when given with drugs cont...

Use of Qualitative Data to Support Content Validity of Performance-Based Cognitive Outcome Assessments.

Dose Finding in Late-Phase Drug Development.

A drug may fail or raise concerns that must be addressed in later-phase trials because of an unacceptable toxicity profile, even if the drug meets expectations for efficacy. The problem could be due to the late onset of unacceptable toxicities that were not observed in early-phase trials. We explore methodologies to find appropriate doses in situations where a drug meets the primary efficacy objective but concerns about toxicity remain. In this manuscript, we propose a general framework to design a good pha...

Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health.

Medicines regulators, while performing a vital public health activity, are often perceived as both negative cost centers for governments and as impediments to innovation and economic development. The Mexican government recently undertook a regulatory optimization program focused on transforming the Mexican medicines regulatory pathway into one that is efficient, value-added, aligned with international norms, resource accountable, and one that protects and promotes public health, while also facilitating econ...

Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars.

Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars, which requires clinical trials to demonstrate that the pharmacokinetic (PK) and clinical efficacy are equivalent. Pharmacodynamics (PD) may be used in evaluating efficacy if there are relevant PD markers available. However, in their absence, it is necessary to design the associated clinical trials to include efficacy measures as the primary endpoint.

Assessing Recall and Recognition for Important Safety Information in Digital Promotion for Pharmaceutical Products: Implications for Website Design.

To date, there has been little research with digital direct-to-consumer (DTC) communication regarding pharmaceutical products (eg, product websites), so this study was designed to measure perception and recall of Important Safety Information (ISI) in websites viewed on desktops and smartphone devices.

Reference Limits for Outlier Analyses in Randomized Clinical Trials.

Reference limits used in clinical medicine to screen and manage patients are typically developed nonparametrically using reference values from a limited number of healthy subjects using a 95th percentile reference interval. We have evaluated alternative methods of computation and the resulting limits for use in the analyses of treatment-emergent outliers in clinical trials.

Proposed Proarrhythmic Cardiac Safety Education in Medical, Pharmacy, and Nursing Schools: An Interprofessional Model.

Evaluating the Completeness of

To date, although studies have been conducted to assess compliance with listing clinical trial information, to our knowledge there is nothing in the literature examining the completion and accuracy of clinical trial site information on .

From the Valley of Death to the Crossroads of Opportunity: A Discussion of Evolving Benefit/Risk Evaluation Standards.

A series of recent US Food and Drug Administration (FDA) approvals (such as Sarepta's Exondys 51, Merck's Keytruda, and Portola's Bevyxxa) has generated significant interest within the drug development ecosystem. Facilitated regulatory pathways aimed toward expediting medicines to patients suffering from serious and life-threatening conditions are a good thing, even if it raises curiosity and introduces some degree of uncertainty. Over the last 20 years, two key words in drug development have been speed and...

Improving Expanded Access in the United States: The Role of the Institutional Review Board.

The FDA allows patients with a serious or immediately life-threatening illness to use investigational medical products outside of clinical trials through its "expanded access" program. In response to criticism that the process to apply for expanded access is too onerous, numerous changes have been made over the last few years. These have been largely focused on the FDA and the pharmaceutical industry, while institutional review boards (IRBs)-which must approve expanded access protocols, except in emergencie...

A Milestone: Therapeutic Innovation & Regulatory Science Has Been Accepted for Inclusion in MEDLINE.

Keeping a Focus on Research Ethics.

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement.

Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI's Patient Groups and Clinical Trials Project.

While patient groups, regulators, and sponsors are increasingly considering engaging with patients in the design and conduct of clinical development programs, sponsors are often reluctant to go beyond pilot programs because of uncertainty in the return on investment. We developed an approach to estimate the financial value of patient engagement.

Use of Proprietary Names by Prescribers for Generic Products.

Proprietary names are often used when prescribing drug products in the United States. The purpose of this study is to describe prescribers' use of proprietary names for generic products, branded-generic names, on prescription orders and to identify prescribing practice trends to inform the development and evaluation of new proprietary names.

Introduction to the Special Section for Sources of Safety Data and Statistical Strategies for Design and Analysis.

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