Neonatal medicines research: challenges and opportunities.

Abstract:

INTRODUCTION:The key feature of the newborn is its fast age-dependent maturation, resulting in extensive variability in pharmacokinetics and -dynamics, further aggravated by newly emerging covariates like treatment modalities, environmental issues or pharmacogenetics. This makes clinical research in neonates relevant and needed, but also challenging. AREAS COVERED:To improve this knowledge, tailoring research tools as well as building research networks and clinical research skills for neonates are urgently needed. Tailoring of research tools is illustrated using the development of dried blood spot techniques and the introduction of micro-dosing and -tracer methodology in neonatal drug studies. Both techniques can be combined with sparse sampling techniques through population modeling. Building research networks and clinical research skills is illustrated by the initiatives of agencies to build and integrate knowledge on neonatal pharmacotherapy through dedicated working groups. EXPERT OPINION:Challenges relating to neonatal medicine research can largely be overcome. Tailored tools and legal initiatives, combined with clever trial design will result in more robust information on neonatal pharmacotherapy. This necessitates collaborative efforts between clinical researchers, sponsors, regulatory authorities, and last but not least patient representatives and society.

authors

Samardzic J,Turner MA,Bax R,Allegaert K

doi

10.1517/17425255.2015.1046433

subject

Has Abstract

pub_date

2015-07-01 00:00:00

pages

1041-52

issue

7

eissn

1742-5255

issn

1744-7607

journal_volume

11

pub_type

杂志文章,评审
  • Pharmacokinetic drug evaluation of mepolizumab for the treatment of severe asthma associated with persistent eosinophilic inflammation in adults.

    abstract:INTRODUCTION:Mepolizumab is a humanized monoclonal antibody that binds to and inactivates IL-5. It is available as a subcutaneous preparation. The practical application of mepolizumab is as an add-on therapy in the treatment of severe eosinophilic asthma. Areas covered: This article was created from a comprehensive lit...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2017.1406919

    authors: Kallur L,Gonzalez-Estrada A,Eidelman F,Dimov V

    更新日期:2017-12-01 00:00:00

  • An update on chemotherapy and tumor gene expression profiles in breast cancer.

    abstract:INTRODUCTION:Various trials have attempted to develop gene expression profiles (GEPs) that may provide a better predictor of clinical outcome over traditional clinicopathological criteria. AREAS COVERED:The review focuses on two main areas: trials examining chemotherapy-induced GEP changes pre- and post-treatment, and...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2012.694867

    authors: Tan SH,Lee SC

    更新日期:2012-09-01 00:00:00

  • The regulation of human hepatic drug transporter expression by activation of xenobiotic-sensing nuclear receptors.

    abstract:INTRODUCTION:If a drug is found to be an inducer of hepatic drug metabolizing enzymes via activation of nuclear receptors such as pregnane X receptor (PXR) or constitutive androstane receptor (CAR), it is likely that drug transporters regulated through these same receptors will be induced as well. This review highlight...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2016.1223626

    authors: Amacher DE

    更新日期:2016-12-01 00:00:00

  • Clinical significance of chemokine receptor antagonists.

    abstract::Introduction: Chemokine receptors are important therapeutic targets for the treatment of many human diseases. This study will provide an overview of approved chemokine receptor antagonists and promising candidates in advanced clinical trials.Areas covered: We will describe clinical aspects of chemokine receptor antago...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2020.1711884

    authors: Miao M,De Clercq E,Li G

    更新日期:2020-01-01 00:00:00

  • Implications of HLA-allele associations for the study of type IV drug hypersensitivity reactions.

    abstract:INTRODUCTION:Type IV drug hypersensitivity remains an important clinical problem and an obstacle to the development of new drugs. Several forms of drug hypersensitivity are associated with expression of specific HLA alleles. Furthermore, drug-specific T-lymphocytes have been isolated from patients with reactions. Despi...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2018.1441285

    authors: Sullivan A,Watkinson J,Waddington J,Park BK,Naisbitt DJ

    更新日期:2018-03-01 00:00:00

  • 4th Annual Predictive Toxicology Summit 2012.

    abstract:INTRODUCTION:This meeting report presents a brief summary on the 4th Annual Predictive Toxicology Summit 2012, which was held on 15 - 16 February 2012 in London. AREAS COVERED:The majority of presentations came from global pharmaceutical companies, although small and medium enterprise (SME) and academic researchers we...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1517/17425255.2013.802306

    authors: Cui Z

    更新日期:2013-08-01 00:00:00

  • Genetic variation in androgen disposition: implications in clinical medicine including testosterone abuse.

    abstract:BACKGROUND:Testosterone replacement therapy in hypogonadal men has been used for > 60 years. The use of testosterone substitution is continuously growing and is given to aging men to improve the quality of life. Because testosterone use is associated with muscle strength enhancing effects, it has become a popular drug ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425250902976862

    authors: Schulze JJ,Rane A,Ekström L

    更新日期:2009-07-01 00:00:00

  • Pharmacogenetics of anticoagulants used for stroke prevention in patients with atrial fibrillation.

    abstract::Introduction: The inclusion of pharmacogenetics alongside clinical information in anticoagulant therapy offers the opportunity for a tailored approach to treatment according to individual patient characteristics. Areas covered: Literature was searched using PubMed database, focusing on pharmacogenetics of oral anticoa...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2019.1623878

    authors: Kampouraki E,Kamali F

    更新日期:2019-06-01 00:00:00

  • Tolerability considerations for gonadotropin-releasing hormone analogues for endometriosis.

    abstract:INTRODUCTION:The second-line treatment of endometriosis-related pain symptoms includes injectable depot formulations of gonadotropin-releasing hormone analogs (GnRH-as). These drugs improve the symptomatology by inducing a hypoestrogenic status and a consequent regression of endometriotic implants. However, GnRH-a may ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1080/17425255.2020.1789591

    authors: Della Corte L,Barra F,Mercorio A,Evangelisti G,Rapisarda AMC,Ferrero S,Bifulco G,Giampaolino P

    更新日期:2020-09-01 00:00:00

  • Tailored tools to improve pharmacotherapy in infants.

    abstract:INTRODUCTION:Extensive within-population variability is the essence of neonatal pharmacology. Despite this, infants remain one of the last therapeutic orphans. Together with additional legal initiatives, tailoring of already available tools (modeling, covariates, pharmacovigilance) may significantly improve pharmacothe...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2014.931937

    authors: Allegaert K

    更新日期:2014-08-01 00:00:00

  • Renal toxic ingredients and their toxicology from traditional Chinese medicine.

    abstract:INTRODUCTION:There have been increasing concerns regarding adverse reactions and toxicity incidents caused by traditional Chinese medicines (TCMs), among which the nephrotoxicity is particularly worrying. AREAS COVERED:This review summarizes the ingredients with renal toxicity from some TCMs through searching the rele...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2016.1132306

    authors: Xu XL,Yang LJ,Jiang JG

    更新日期:2016-01-01 00:00:00

  • Sex-specific differences in CYP450 isoforms in humans.

    abstract:BACKGROUND:The activity of various CYP isoforms is critical for maintaining the clinical effectiveness of many medications. Therefore, determining the sex-dependent activity of clinically relevant CYP families is highly important for optimal therapeutic effectiveness. OBJECTIVE:This review examined the sex-dependent a...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.4.4.413

    authors: Scandlyn MJ,Stuart EC,Rosengren RJ

    更新日期:2008-04-01 00:00:00

  • Modifications of human carboxylesterase for improved prodrug activation.

    abstract:BACKGROUND:Carboxylesterases (CEs) are ubiquitous enzymes responsible for the hydrolysis of numerous clinically useful drugs. As ester moieties are frequently included in molecules to improve their water solubility and bioavailability, de facto they become substrates for CEs. OBJECTIVE:In this review, we describe the ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.4.9.1153

    authors: Hatfield JM,Wierdl M,Wadkins RM,Potter PM

    更新日期:2008-09-01 00:00:00

  • The role of afatinib in the management of non-small cell lung carcinoma.

    abstract:INTRODUCTION:Despite initial patient benefit, drug resistance to first-generation EGFR tyrosine kinase inhibitors (TKIs) is inevitable. One of the key mechanisms responsible for the development of acquired drug resistance is the secondary T790M missense mutation in exon 20 of the EGFR kinase domain. Afatinib is an ATP-...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2013.832755

    authors: Yap TA,Popat S

    更新日期:2013-11-01 00:00:00

  • Glucuronidation of capsaicin by liver microsomes and expressed UGT enzymes: reaction kinetics, contribution of individual enzymes and marked species differences.

    abstract:OBJECTIVE:The objectives of this study are to characterize capsaicin glucuronidation using liver microsomes and to determine the contribution of individual UDP-glucuronosyltransferase (UGT) enzymes to hepatic glucuronidation of capsaicin. METHODS:The rates of glucuronidation were determined by incubating capsaicin wit...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1517/17425255.2014.954548

    authors: Sun H,Wang H,Liu H,Zhang X,Wu B

    更新日期:2014-10-01 00:00:00

  • Pharmacokinetic and pharmacodynamic evaluation of oxycodone and naltrexone for the treatment of chronic lower back pain.

    abstract:INTRODUCTION:Chronic low back pain (CLBP) is a common and difficult illness to manage. Some individuals with CLBP have pain processing disorders and are also at risk for opioid abuse, misuse; addiction and diversion. Guidelines have been published to guide management; neuromodulation, exercise, mindfulness-based stress...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2016.1191469

    authors: Davis MP

    更新日期:2016-07-01 00:00:00

  • Current understanding of pharmacogenetic implications of DNA damaging drugs used in osteosarcoma treatment.

    abstract:INTRODUCTION:DNA damaging drugs are widely used for the chemotherapeutic treatment of high-grade osteosarcoma (HGOS). In HGOS patients, several germline polymorphisms have been reported to impact on the development of adverse toxic events related to DNA damaging drugs treatment. Some of these polymorphisms, when presen...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2019.1588885

    authors: Hattinger CM,Patrizio MP,Luppi S,Magagnoli F,Picci P,Serra M

    更新日期:2019-04-01 00:00:00

  • Molecular mechanisms for drug interactions with hERG that cause long QT syndrome.

    abstract::The human ether-a-go-go-related gene (hERG) encodes the pore-forming alpha-subunit of a voltage-gated potassium (K(+)) channel. A variety of unrelated compounds reduce K(+ )current in the heart by blocking the pore or disrupting trafficking of the hERG channel to the membrane surface. This induces a syndrome known as ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2.1.81

    authors: Stansfeld PJ,Sutcliffe MJ,Mitcheson JS

    更新日期:2006-02-01 00:00:00

  • Updated pharmacokinetic considerations for the use of antimalarial drugs in pregnant women.

    abstract:INTRODUCTION:The association between pregnancy and altered drug pharmacokinetic (PK) properties is acknowledged, as is its impact on drug plasma concentrations and thus therapeutic efficacy. However, there have been few robust PK studies of antimalarial use in pregnancy. Given that inadequate dosing for prevention or t...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章

    doi:10.1080/17425255.2020.1802425

    authors: Moore BR,Davis TM

    更新日期:2020-09-01 00:00:00

  • Metabolic and toxicological considerations of newly approved prostate cancer drugs.

    abstract:INTRODUCTION:Despite increasing early detection and treatment of prostate cancer, a subset of patients presents with or develops metastatic disease. Androgen deprivation therapy is effective but resistance eventually develops, resulting in a lethal phenotype known as castration-resistant prostate cancer (CRPC). Recentl...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2013.789019

    authors: Tsao CK,Liaw B,Yee T,Galsky MD,Oh WK

    更新日期:2013-07-01 00:00:00

  • Pharmacokinetic evaluation of pregabalin for the treatment of generalized anxiety disorder.

    abstract:INTRODUCTION:Pregabalin is an alternative compound to SSRIs and SNRIs for the first-line treatment of generalized anxiety disorder (GAD). Areas covered: We describe the pharmacokinetic properties of pregabalin and their implications for the treatment of GAD. A search in the main database sources (Medline, ISI, Web of K...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1080/17425255.2017.1281247

    authors: Buoli M,Caldiroli A,Serati M

    更新日期:2017-03-01 00:00:00

  • Sumatriptan: a review of its pharmacokinetics, pharmacodynamics and efficacy in the acute treatment of migraine.

    abstract:INTRODUCTION:Sumatriptan was developed more than 20 years ago as a 5-HT1B/1D receptor agonist, the first drug in a new class of specific anti-migraine drugs, the triptans. A large amount of information and experience has been gained from the clinical trials undertaken as well the various formulations of sumatriptan use...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2013.744394

    authors: Tfelt-Hansen P,Hougaard A

    更新日期:2013-01-01 00:00:00

  • Bioaccessibility of polycyclic aromatic hydrocarbons: relevance to toxicity and carcinogenesis.

    abstract:INTRODUCTION:Bioaccessibility is a growing area of research in the field of risk assessment. As polycyclic aromatic hydrocarbons (PAHs) are ubiquitous environmental pollutants, they are the toxicants of focus to establish cancer risks in humans. Orally ingested PAHs also cause toxicity and even affect the pharmacokinet...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2013.823157

    authors: Harris KL,Banks LD,Mantey JA,Huderson AC,Ramesh A

    更新日期:2013-11-01 00:00:00

  • Pharmacokinetic evaluation of rivaroxaban for the treatment of acute coronary syndromes.

    abstract:INTRODUCTION:Arterial and venous thrombotic states, including myocardial infarction (MI), stroke and deep vein thrombosis with subsequent pulmonary embolism, are a significant cause of cardiovascular mortality and morbidity. Factor Xa (FXa) plays a pivotal role in thrombus formation. Its inhibition following acute coro...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2012.688026

    authors: Gopalakrishnan L,Kumar V,Kohli P,Singh P,Rastogi U,Gibson CM

    更新日期:2012-07-01 00:00:00

  • Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine.

    abstract:OBJECTIVES:A medical need remains for a once-daily insulin with 24-h basal coverage in all patients. We characterize the steady-state (SS) pharmacokinetic/pharmacodynamic properties of insulin degludec (IDeg) versus insulin glargine (IGlar). RESEARCH DESIGN AND METHODS:In this controlled, single-center study, 66 type ...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,随机对照试验

    doi:10.1517/17425255.2015.1058779

    authors: Heise T,Hövelmann U,Nosek L,Hermanski L,Bøttcher SG,Haahr H

    更新日期:2015-01-01 00:00:00

  • Sertindole: pharmacological and clinical profile and role in the treatment of schizophrenia.

    abstract:BACKGROUND:Sertindole is a second-generation antipsychotic recently reintroduced in the market for the treatment of schizophrenia after a reevaluation of its risks and benefits. OBJECTIVE:This article provides an overview of the pharmacological properties of sertindole as well as of its efficacy, tolerability and safe...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.4.5.629

    authors: Spina E,Zoccali R

    更新日期:2008-05-01 00:00:00

  • Applications of physiologically based pharmacokinetic modeling for the optimization of anti-infective therapies.

    abstract:INTRODUCTION:The pharmacokinetic properties of anti-infective drugs are a determinant part of treatment success. Pathogen replication is inhibited if adequate drug levels are achieved in target sites, whereas excessive drug concentrations linked to toxicity are to be avoided. Anti-infective distribution can be predicte...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2015.1037278

    authors: Moss DM,Marzolini C,Rajoli RK,Siccardi M

    更新日期:2015-01-01 00:00:00

  • Stability of peptides and therapeutic success in cancer.

    abstract:INTRODUCTION:Although naturally occurring peptides have been widely used as drugs, their rapid in vivo degradation by proteolysis and their interactions at multiple receptors are part of the reason for the limitation of their clinical applications. AREAS COVERED:This paper reviews peptide-metabolizing enzymes in the b...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2011.574126

    authors: Pernot M,Vanderesse R,Frochot C,Guillemin F,Barberi-Heyob M

    更新日期:2011-07-01 00:00:00

  • Precision-cut intestinal slices: alternative model for drug transport, metabolism, and toxicology research.

    abstract:INTRODUCTION:The absorption, distribution, metabolism, excretion and toxicity (ADME-tox) processes of drugs are of importance and require preclinical investigation intestine in addition to the liver. Various models have been developed for prediction of ADME-tox in the intestine. In this review, precision-cut intestinal...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.2016.1125882

    authors: Li M,de Graaf IA,Groothuis GM

    更新日期:2016-01-01 00:00:00

  • Physiologically based approaches towards the prediction of pharmacokinetics: in vitro-in vivo extrapolation.

    abstract::In adapting to the challenge to make more informed selection of compounds for development, the pharmaceutical industry is increasingly embracing the application of mechanism-based models and prediction tools for prediction of pharmacokinetic parameters. This review first outlines the concepts and application of the ma...

    journal_title:Expert opinion on drug metabolism & toxicology

    pub_type: 杂志文章,评审

    doi:10.1517/17425255.3.6.865

    authors: De Buck SS,Mackie CE

    更新日期:2007-12-01 00:00:00