Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics.

Abstract:

:Adopted guidelines reflect a harmonised European approach to a specific scientific issue and should reflect the most recent scientific knowledge. However, whilst EU regulations are mandatory for all member states and EU directives must be followed by national laws in line with the directive, EMA guidelines do not have legal force and alternative approaches may be taken, but these obviously require more justification. This new series of the BJCP, developed in collaboration with the EMA, aims to address this issue by providing an annotated version of some relevant EMA guidelines and regulatory documents by experts. Hopefully, this will help in promoting their diffusion and in opening a forum for discussion with our readers.

journal_name

Br J Clin Pharmacol

authors

Ollivier C,Thomson A,Manolis E,Blake K,Karlsson KE,Knibbe CAJ,Pons G,Hemmings R

doi

10.1111/bcp.13883

subject

Has Abstract

pub_date

2019-04-01 00:00:00

pages

659-668

issue

4

eissn

0306-5251

issn

1365-2125

journal_volume

85

pub_type

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    authors: Trull AK,Tan KK,Tan L,Alexander GJ,Jamieson NV

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  • Maprotiline metabolism appears to co-segregate with the genetically-determined CYP2D6 polymorphic hydroxylation of debrisoquine.

    abstract::The plasma concentrations of the tetracyclic antidepressant maprotiline and its effect on histamine-induced bronchoconstriction were measured after single (50 mg) and multiple (50 mg twice daily) oral doses in healthy subjects. Histamine-induced bronchoconstriction was abolished after a single dose of maprotiline and ...

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    authors: Firkusny L,Gleiter CH

    更新日期:1994-04-01 00:00:00

  • Pharmacokinetics and tolerability of oral rizatriptan in healthy male and female volunteers.

    abstract:AIMS:The pharmacokinetics and dose proportionality of rizatriptan single oral doses from 2.5 to 15 mg administered as solutions to healthy volunteers were studied. METHODS:In a randomized, crossover study with four periods, twenty-four healthy volunteers (12 males and 12 females) took single oral doses of 2.5, 5, 10, ...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1365-2125.1999.00917.x

    authors: Lee Y,Conroy JA,Stepanavage ME,Mendel CM,Somers G,McLoughlin DA,Olah TV,De Smet M,Keymeulen B,Rogers JD

    更新日期:1999-04-01 00:00:00

  • Dose-linearity of the pharmacokinetics of an intravenous [14 C]midazolam microdose in children.

    abstract:AIMS:Drug disposition in children may vary from adults due to age-related variation in drug metabolism. Microdose studies present an innovation to study pharmacokinetics (PK) in paediatrics; however, they should be used only when the PK is dose linear. We aimed to assess dose linearity of a [14 C]midazolam microdose, b...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,多中心研究

    doi:10.1111/bcp.14047

    authors: van Groen BD,Vaes WH,Park BK,Krekels EHJ,van Duijn E,Kõrgvee LT,Maruszak W,Grynkiewicz G,Garner RC,Knibbe CAJ,Tibboel D,de Wildt SN,Turner MA

    更新日期:2019-10-01 00:00:00

  • The pharmacokinetics of oxycodone after intravenous injection in adults.

    abstract::Oxycodone chloride (0.07 mg kg-1) was given by intravenous bolus to nine young adult surgical patients on the first postoperative day. Plasma was sampled for up to 12 h. Mean values of t1/2z, CL and Vss were 222 min, 0.78 l min-1 and 2.60 l kg-1, respectively. The concentrations of the metabolite noroxycodone was also...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1991.tb03942.x

    authors: Pöyhiä R,Olkkola KT,Seppälä T,Kalso E

    更新日期:1991-10-01 00:00:00

  • Pharmacokinetics of hydrochlorothiazide in patients with congestive heart failure.

    abstract::1. Hydrochlorothiazide (HCT, 50-75 mg) was administered orally to seven patients with cardiac failure. 2. Plasma levels and urinary concentration of HCT were determined by GLC. 3. The gastrointestinal uptake of the diuretic in three patients was reduced to approximately half that seen in healthy controls. 4. Plasma ha...

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    authors: Beermann B,Groschinsky-Grind M

    更新日期:1979-06-01 00:00:00

  • Maternal and fetal zidovudine pharmacokinetics during pregnancy and labour: too high dose infused at labour?

    abstract:AIMS:The main goal of the study was to describe the pharmacokinetics of maternal zidovudine (ZDV) administration during pregnancy and labour and to evaluate their impact on fetal concentrations and exposures. METHODS:A total of 195 HIV-infected pregnant and non-pregnant women aged 16-59 years were included and 273 mat...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.12459

    authors: Fauchet F,Treluyer JM,Valade E,Benaboud S,Pannier E,Firtion G,Foissac F,Bouazza N,Urien S,Hirt D

    更新日期:2014-12-01 00:00:00

  • Antiplatelet therapy: thrombin receptor antagonists.

    abstract::Activated platelets stimulate thrombus formation in response to rupture of an atherosclerotic plaque or endothelial cell erosion, promoting atherothrombotic disease. Multiple pathways contribute to platelet activation. Aspirin, an irreversible inhibitor of thromboxane A2 synthesis, in combination with clopidogrel, an ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1111/j.1365-2125.2010.03884.x

    authors: Tello-Montoliu A,Tomasello SD,Ueno M,Angiolillo DJ

    更新日期:2011-10-01 00:00:00

  • Reduced platelet aggregation after fluvastatin therapy is associated with altered platelet lipid composition and drug binding to the platelets.

    abstract:AIMS:High plasma cholesterol concentration and increased platelet activity are two major risk factors for atherosclerosis. Lovastatin, the lipophilic drug was shown to inhibit platelet aggregation whereas pravastatin, the hydrophilic drug had no such effect. Analysis of the effect of fluvastatin which is both a lipophi...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1046/j.1365-2125.1997.00625.x

    authors: Osamah H,Mira R,Sorina S,Shlomo K,Michael A

    更新日期:1997-07-01 00:00:00

  • Comparative wheal and flare study of mizolastine vs terfenadine, cetirizine, loratadine and placebo in healthy volunteers.

    abstract::1. Mizolastine, a new benzimidazole derivative with potent selective, non-sedative H1-histamine antagonist activity was compared with terfenadine, cetirizine and loratadine using the histamine-induced wheal and flare model in healthy volunteers. 2. Study design was a five way double-blind crossover design using a sing...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Rosenzweig P,Caplain H,Chaufour S,Ulliac N,Cabanis MJ,Thebault JJ

    更新日期:1995-11-01 00:00:00

  • The contribution of genetically determined oxidation status to inter-individual variation in phenacetin disposition.

    abstract::The oxidative O-de-ethylation and aromatic 2-hydroxylation of phenacetin have been investigated in panels of extensive (EM, n = 13) and poor (PM, n = 10) metabolizers of debrisoquine. The EM group excreted in the urine significantly more paracetamol (EM: 40.8 +/- 14.9% dose/0-8 h; PM: 29.2 +/- 8.7% dose/0-8 h, 2P less...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1983.tb04980.x

    authors: Devonshire HW,Kong I,Cooper M,Sloan TP,Idle JR,Smith RL

    更新日期:1983-08-01 00:00:00

  • Population pharmacokinetic study of gentamicin in a large cohort of premature and term neonates.

    abstract:AIM:This study aims to investigate the clinical and demographic factors influencing gentamicin pharmacokinetics in a large cohort of unselected premature and term newborns and to evaluate optimal regimens in this population. METHODS:All gentamicin concentration data, along with clinical and demographic characteristics...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.12444

    authors: Fuchs A,Guidi M,Giannoni E,Werner D,Buclin T,Widmer N,Csajka C

    更新日期:2014-11-01 00:00:00

  • Reversal of mecamylamine-induced effects in healthy subjects by nicotine receptor agonists: Cognitive and (electro) physiological responses.

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    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/bcp.13507

    authors: Alvarez-Jimenez R,Hart EP,Prins S,de Kam M,van Gerven JMA,Cohen AF,Groeneveld GJ

    更新日期:2018-05-01 00:00:00

  • Role of TDM-based dose adjustments for taxane anticancer drugs.

    abstract::The classical taxanes (paclitaxel, docetaxel), the newer taxane cabazitaxel and the nanoparticle-bound nab-paclitaxel are among the most widely used anticancer drugs. Still, the optimal use and the value of pharmacological personalization of the taxanes is still controversial. We give an overview on the pharmacologica...

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    pub_type: 杂志文章,评审

    doi:10.1111/bcp.14678

    authors: Muth M,Ojara FW,Kloft C,Joerger M

    更新日期:2020-11-28 00:00:00

  • A double-blind multicentre trial comparing mianserin with imipramine.

    abstract::1. Fifty-four depressive in-patients aged 18-45 yr, were treated at random, in double-blind conditions, with mianserin 60 mg daily or imipramine 150 mg daily in three divided doses for 4 weeks. Nitrazepam and diazepam were also allowed if necessary. 2. There was no significant difference in antidepressant efficacy bet...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Pichot P,Dreyfus JF,Pull C

    更新日期:1978-01-01 00:00:00

  • Comparative effects of lisinopril and losartan on insulin sensitivity in the treatment of non diabetic hypertensive patients.

    abstract:AIMS:The aim of this study was to compare the effects of the ACE-inhibitor lisinopril and the angiotensin II receptor antagonist losartan on insulin sensitivity in the treatment of non diabetic hypertensives. METHODS:Twenty-five non diabetic subjects with mild to moderate hypertension, 11 females and 14 males, aged 44...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1046/j.1365-2125.1998.00811.x

    authors: Fogari R,Zoppi A,Corradi L,Lazzari P,Mugellini A,Lusardi P

    更新日期:1998-11-01 00:00:00

  • Assuming one dose per day yields a similar estimate of medication adherence in patients with stroke: An exploratory analysis using linked registry data.

    abstract:PURPOSE:Prescribed daily dose (PDD), the number of doses prescribed to be taken per day, is used to calculate medication adherence using pharmacy claims data. PDD can be substituted by (i) one dose per day (1DD), (ii) an estimate based on the 75th percentile of days taken by patients to refill a script (PDD75 ) or (iii...

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    pub_type: 杂志文章

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    authors: Ung D,Dalli LL,Lopez D,Sanfilippo FM,Kim J,Andrew NE,Thrift AG,Cadilhac DA,Anderson CS,Kilkenny MF

    更新日期:2020-07-08 00:00:00

  • The induction effect of rifampicin on activity of mephenytoin 4'-hydroxylase related to M1 mutation of CYP2C19 and gene dose.

    abstract:AIMS:To determine the induction effect of rifampicin on the activity of 4'-hydroxylase in poor metabolizers (PMs) with m1 mutation of S-mephenytoin 4'-hydroxylation and the relationship of the effect with gene dose. METHODS:Seven extensive metabolizers (EMs) of S-mephenytoin 4'-hydroxylation and five PMs with m1 mutat...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1046/j.1365-2125.1998.00643.x

    authors: Feng HJ,Huang SL,Wang W,Zhou HH

    更新日期:1998-01-01 00:00:00

  • The effect of a protein meal on zidovudine pharmacokinetics in HIV-infected patients.

    abstract::Eleven HIV-infected men participated in a randomized, two-treatment, two-period crossover study to determine the effect of a 25 g protein meal on zidovudine pharmacokinetics. On two separate occasions, 1 week apart, each patient received 200 mg zidovudine in a fasting state or immediately following the protein meal. A...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1111/j.1365-2125.1992.tb04097.x

    authors: Sahai J,Gallicano K,Garber G,McGilveray I,Hawley-Foss N,Turgeon N,Cameron DW

    更新日期:1992-06-01 00:00:00

  • A framework for simplification of quantitative systems pharmacology models in clinical pharmacology.

    abstract::Quantitative systems pharmacology (QSP) is a relatively new discipline within modelling and simulation that has gained wide attention over the past few years. The application of QSP models spans drug-target identification and validation, through all drug development phases as well as clinical applications. Due to thei...

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    pub_type: 杂志文章,评审

    doi:10.1111/bcp.14451

    authors: Derbalah A,Al-Sallami H,Hasegawa C,Gulati A,Duffull SB

    更新日期:2020-07-04 00:00:00

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    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.12573

    authors: Grimes RT,Bennett K,Tilson L,Usher C,Smith SM,Henman MC

    更新日期:2015-06-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1111/bcp.14332

    authors: Westerdijk K,Krens SD,van der Graaf WTA,Mulder SF,van Herpen CML,Smilde T,van Erp NP,Desar IME

    更新日期:2020-05-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1986.tb05193.x

    authors: Downey KM,Chaput de Saintonge DM

    更新日期:1986-03-01 00:00:00

  • The disposition of amodiaquine in man after oral administration.

    abstract::A method is described for the simultaneous determination of amodiaquine (AQ) and desethylamodiaquine (AQm) in plasma, urine, whole blood and packed red cells. After oral administration of AQ (600 mg) to seven healthy subjects, absorption of AQ was rapid, reaching peak concentrations in plasma, whole blood, and packed ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1987.tb03002.x

    authors: Winstanley P,Edwards G,Orme M,Breckenridge A

    更新日期:1987-01-01 00:00:00

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    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1046/j.1365-2125.2001.01254.x

    authors: O'Shaughnessy KM

    更新日期:2001-01-01 00:00:00

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    abstract:AIMS:To develop a population pharmacokinetic model for mycophenolic acid (MPA) in children with idiopathic nephrotic syndrome (INS) treated with mycophenolate mofetil (MMF), identify covariates that explain variability and determine the Bayesian estimator of the area under the concentration-time curve over 12 h (AUC(0-...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章,多中心研究

    doi:10.1111/j.1365-2125.2010.03615.x

    authors: Zhao W,Elie V,Baudouin V,Bensman A,André JL,Brochard K,Broux F,Cailliez M,Loirat C,Jacqz-Aigrain E

    更新日期:2010-04-01 00:00:00

  • The pharmacokinetics of nortriptyline in patients with chronic renal failure.

    abstract::1 The pharmacokinetics of single oral doses of nortriptyline were studied in twenty patients with chronic renal failure, eight of whom were receiving treatment with haemodialysis. 2 The median nortriptyline half-life was 25.2 h (range 14.5-140.0 h) and the median nortriptyline clearance was 32.3 l/h (range 8.1-122.0 l...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1981.tb01852.x

    authors: Dawlilng S,Lynn K,Rosser R,Braithwaite R

    更新日期:1981-07-01 00:00:00

  • Anti-factor Xa activity of enoxaparin administered at prophylactic dosage to patients over 75 years old.

    abstract:AIMS:Major bleeding complications with low-molecular-weight heparin (LMWH) treatment have been reported both in clinical studies and during postmarketing surveillance. Monitoring of antifactor Xa (anti-Xa) activities is therefore recommended in special populations often predisposed to renal impairment. The PROPHRE.75 s...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2007.02920.x

    authors: Berges A,Laporte S,Epinat M,Zufferey P,Alamartine E,Tranchand B,Decousus H,Mismetti P,PROPHRE.75 Study Group.

    更新日期:2007-10-01 00:00:00

  • Aprepitant and fosaprepitant drug interactions: a systematic review.

    abstract:AIMS:Aprepitant and fosaprepitant, commonly used for the prevention of chemotherapy-induced nausea and vomiting, alter cytochrome P450 activity. This systematic review evaluates clinically significant pharmacokinetic drug interactions with aprepitant and fosaprepitant and describes adverse events ascribed to drug inter...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,meta分析,评审

    doi:10.1111/bcp.13322

    authors: Patel P,Leeder JS,Piquette-Miller M,Dupuis LL

    更新日期:2017-10-01 00:00:00

  • Antipyrine elimination in saliva after low-dose combined or progestogen-only oral contraceptive steroids.

    abstract::1 A 'low-dose' combined oral contraceptive steroid (OCS) preparation containing 30 microgram ethinylo-estradiol and 150 microgram levonorgestrel was found to reduce significantly antipyrine clearance in a group of women acting as their own controls. 2 An OCS preparation containing only a progestogen (75 microgram norg...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1982.tb01362.x

    authors: Chambers DM,Jefferson GC,Chambers M,Loudon NB

    更新日期:1982-02-01 00:00:00