Quality and safety of herbal medical products: regulation and the need for quality assurance along the value chains.

Abstract:

:Herbal medicines and products derived from them are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiversity rich countries with the large markets in the North. This paper discusses the current regulatory framework of such herbal medical products (with a focus on the UK) and using examples from our own metabolomic research on Curcumal longa L. (turmeric, Zingiberaceae) how value chains impact on the composition and quality (and thus the safety) of such products. Overall, our recent research demonstrates the need for studying the links between producers and consumers of commodities produced in provider countries and that plant metabolomics offer a novel way of assessing the chemical variability along a value chain.

journal_name

Br J Clin Pharmacol

authors

Heinrich M

doi

10.1111/bcp.12586

subject

Has Abstract

pub_date

2015-07-01 00:00:00

pages

62-6

issue

1

eissn

0306-5251

issn

1365-2125

journal_volume

80

pub_type

杂志文章,评审
  • Cardiovascular responses to mianserin hydrochloride: a comparison with tricyclic antidepressant drugs.

    abstract::1. The cardiovascular responses of mianserin hydrochloride and tricyclic antidepressant drugs were investigated using non-invasive methods of cardiac investigation. A study of the interaction of mianserin and antihypertensive drug therapy is reported. 2. In six normal volunteers, mianserin hydrochloride 20 mg was show...

    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: Burgess CD,Turner P,Wadsworth J

    更新日期:1978-01-01 00:00:00

  • Minimal effect of MDR1 and CYP3A5 genetic polymorphisms on the pharmacokinetics of indinavir in HIV-infected patients.

    abstract:AIMS:The protease inhibitor indinavir is characterized by an important interindividual pharmacokinetic variability, which results from the actions of the metabolizing enzymes cytochrome P450 (CYP) 3A and the multidrug efflux pump P-glycoprotein (P-gp), encoded by MDR1. Using a population pharmacokinetic approach, we in...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2007.02903.x

    authors: Solas C,Simon N,Drogoul MP,Quaranta S,Frixon-Marin V,Bourgarel-Rey V,Brunet C,Gastaut JA,Durand A,Lacarelle B,Poizot-Martin I

    更新日期:2007-09-01 00:00:00

  • Pharmacokinetics of physostigmine in man following a single application of a transdermal system.

    abstract::1. The pharmacokinetics of physostigmine were investigated in a three-way cross-over design in six healthy, male volunteers comparing a physostigmine transdermal system (PTS), an oral solution and an i.v. infusion. 2. A single application of the patch over 24 h produced detectable plasma drug concentrations after a me...

    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.1365-2125.1995.tb04410.x

    authors: Walter K,Müller M,Barkworth MF,Nieciecki AV,Stanislaus F

    更新日期:1995-01-01 00:00:00

  • The effect of acebutolol and propranolol on the hypoglycaemic action of glibenclamide.

    abstract::1 The effect of acebutolol, a relatively selective beta-adrenoceptor blocking drug and propranolol, a non-selective one, on the hypoglycaemic action of glibenclamide after an oral glucose load has been investigated in a group of maturity-onset diabetic patients. 2 Glibenclamide significantly reduced the blood glucose ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1982.tb01412.x

    authors: Zaman R,Kendall MJ,Biggs PI

    更新日期:1982-04-01 00:00:00

  • Effect of beta-adrenoceptor blockade on atrial natriuretic peptide levels during exercise in angina pectoris.

    abstract::The effects of epanolol (200 mg once daily) and diltiazem (60 mg three times daily) on the response of atrial natriuretic peptide (ANP) to exercise were investigated in a double-blind placebo-controlled crossover study in 16 patients with angina pectoris. Exercise tolerance as assessed by peak oxygen consumption was s...

    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: Riley M,Elborn JS,Onuoha G,Erwin C,Shaw C,Khan MM,Stanford CF,Nicholls DP

    更新日期:1993-02-01 00:00:00

  • The pharmacokinetics, antihistamine and concentration-effect relationship of ebastine in healthy subjects.

    abstract::1. The kinetics and effects of ebastine 10 and 50 mg were studied after oral dosing in healthy subjects. 2. The parent drug was extensively metabolised during the first pass to its carboxylic acid derivative, carebastine. 3. The pharmacokinetics of carebastine were linear over the dose range studied and the terminal e...

    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.1365-2125.1988.tb05288.x

    authors: Vincent J,Liminana R,Meredith PA,Reid JL

    更新日期:1988-11-01 00:00:00

  • Pharmacokinetics of a new testosterone transdermal delivery system, TDS-testosterone in healthy males.

    abstract:AIMS:The Transdermal Delivery System (TDS) is a liquid formulation that can be applied to the skin via a metered pump spray to deliver drug to the systemic circulation. The aims of this study were to assess the ability of the TDS preparation to deliver testosterone systemically, and to characterize the pharmacokinetic ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,随机对照试验

    doi:10.1111/j.1365-2125.2005.02542.x

    authors: Chik Z,Johnston A,Tucker AT,Chew SL,Michaels L,Alam CA

    更新日期:2006-03-01 00:00:00

  • Plasma melatonin during desmethylimipramine treatment: evidence for changes in noradrenergic transmission.

    abstract::Plasma melatonin was used to determine overall beta-adrenergic transmission through pineal neuro-effector junctions during desmethylimipramine (DMI) treatment in 10 normal subjects. Changes in plasma melatonin indicated that an initial increase in noradrenaline (NA) transmission produced by DMI was counteracted by ada...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1985.tb02717.x

    authors: Cowen PJ,Green AR,Grahame-Smith DG,Braddock LE

    更新日期:1985-06-01 00:00:00

  • Determinants of the elimination of methotrexate and 7-hydroxy-methotrexate following high-dose infusional therapy to cancer patients.

    abstract:AIMS:To characterize determinants of the elimination of methotrexate (MTX) and 7-hydroxy-methotrexate (7-OH-MTX) in patients receiving high-dose MTX therapy (HDMTX). METHODS:24 and 48-h blood samples from 76 patients receiving HDMTX (dose range 300 mg m-2 to 12 g m-2) were analysed, and concentration-time data were su...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2005.02513.x

    authors: Joerger M,Huitema AD,van den Bongard HJ,Baas P,Schornagel JH,Schellens JH,Beijnen JH

    更新日期:2006-07-01 00:00:00

  • Human pharmacology of a performance-enhancing dietary supplement under resting and exercise conditions.

    abstract:WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT:Performance-enhancing dietary supplements have not been clinically tested for safety or efficacy. In clinical trials performed under resting conditions, performance-enhancing supplements raise blood pressure and affect glucose homeostasis. The effect of exercise on the pharmacok...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2008.03144.x

    authors: Haller CA,Duan M,Jacob P 3rd,Benowitz N

    更新日期:2008-06-01 00:00:00

  • Pharmaceutical innovation by the seven UK-owned pharmaceutical companies (1964-1985).

    abstract::1 A total of three hundred and nineteen new chemical entities (NCEs) were investigated in man for the first time between 1964 and 1985 by seven UK-owned pharmaceutical companies. The majority (96.2%), were self-originated by the UK company or one of its overseas subsidiaries. 2 There was an increase in the number of N...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1988.tb03318.x

    authors: Prentis RA,Lis Y,Walker SR

    更新日期:1988-03-01 00:00:00

  • Comparison of digoxin and medigoxin in normal subjects.

    abstract::1 The properties of a recently introduced digitalis glycoside, 4-beta-methyl digoxin (medigoxin) were compared to those of a standard digoxin preparation. Using a radioimmunoassay (RIA) technique, serial plasma levels were recorded for 8 h following a single oral dose in five fasting volunteer subjects, and urinary gl...

    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.1365-2125.1978.tb01686.x

    authors: Hayward RP,Greenwood H,Hamer J

    更新日期:1978-07-01 00:00:00

  • An investigation into the effect of advice from the Scottish Medicines Consortium on the use of medicines in Scotland's Health Service.

    abstract:AIMS:The aims of the study were to determine the effect of advice from the Scottish Medicines Consortium (SMC) on the use of medicines within Scotland's National Health Service (NHS) and generate hypotheses that may explain differences in the impact of advice on the use of individual medicines. METHODS:A retrospective...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2010.03826.x

    authors: Bennie M,Dear J,Hems S,Black C,McIver L,Webb DJ

    更新日期:2011-02-01 00:00:00

  • Betaxolol and glucose-insulin relationships: studies in normal subjects taking glibenclamide or metformin.

    abstract::1. The potential interaction between selective beta 1-adrenoceptor blockers and sulphonylureas or biguanides was studied by comparing the beta 1-adrenoceptor antagonist betaxolol with placebo in 12 normal subjects taking glibenclamide or metformin in a single-blind crossover group study. 2. After a 4 day run-in period...

    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.1365-2125.1990.tb03838.x

    authors: Sinclair AJ,Davies IB,Warrington SJ

    更新日期:1990-11-01 00:00:00

  • Receptor pharmacogenetics: relevance to CNS syndromes.

    abstract::Pharmacogenetic research dedicated to the investigation of inherited factors that influence drug response has produced exciting results over the past decade. Adding to the knowledge that genetic variation in metabolic enzymes may cause drug-related adverse reactions, recent studies indicate that variation in neurotran...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1046/j.1365-2125.2002.01679.x

    authors: Shaikh S,Kerwin RW

    更新日期:2002-10-01 00:00:00

  • The effect of propranolol on paracetamol metabolism in man.

    abstract::Ten healthy volunteers were treated for 4 days with 160 mg propranolol HCl and placebo in random order. At the end of each treatment salivary antipyrine kinetics and the plasma kinetics and urinary excretion of paracetamol and its major metabolites were measured following a 1500 mg oral dose. Propranolol prolonged the...

    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.1365-2125.1990.tb03631.x

    authors: Baraka OZ,Truman CA,Ford JM,Roberts CJ

    更新日期:1990-02-01 00:00:00

  • Oral diacetylmorphine (heroin) yields greater morphine bioavailability than oral morphine: bioavailability related to dosage and prior opioid exposure.

    abstract:AIMS:In the Swiss heroin substitution trials, patients are treated with self-administered diacetylmorphine (heroin). Intravenous administration is not possible in patients that have venosclerosis. Earlier studies have demonstrated that oral diacetylmorphine may be used, although it is completely converted to morphine p...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2008.03286.x

    authors: Halbsguth U,Rentsch KM,Eich-Höchli D,Diterich I,Fattinger K

    更新日期:2008-12-01 00:00:00

  • Population pharmacokinetics of lopinavir in combination with ritonavir in HIV-1-infected patients.

    abstract:AIMS:To develop a population pharmacokinetic model for lopinavir in combination with ritonavir, in which the interaction between both drugs was characterized, and in which relationships between patient characteristics and pharmacokinetics were identified. METHODS:The pharmacokinetics of lopinavir in combination with r...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.2005.02455.x

    authors: Crommentuyn KM,Kappelhoff BS,Mulder JW,Mairuhu AT,van Gorp EC,Meenhorst PL,Huitema AD,Beijnen JH

    更新日期:2005-10-01 00:00:00

  • The effects of magnesium hydroxide on the absorption and efficacy of two glibenclamide preparations.

    abstract::1. The effect of magnesium hydroxide on the absorption and efficacy of two glibenclamide preparations was investigated in healthy volunteers in two separate studies, using a randomized cross-over design with two phases. 2. A single dose of magnesium hydroxide (850 mg) or water only (150 ml) was given immediately after...

    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.1365-2125.1991.tb03884.x

    authors: Neuvonen PJ,Kivistö KT

    更新日期:1991-08-01 00:00:00

  • Inhibition of vasoconstriction by AJ-2615, a novel calcium antagonist with alpha(1)-adrenergic receptor blocking activity in human conduit arteries used as bypass grafts.

    abstract:AIMS:Graft spasm may develop during coronary artery bypass grafting and reversal of spasm is still challenging. The purpose of this study was to investigate the in vitro vascular relaxant properties of AJ-2615 in human internal mammary artery (IMA). METHODS:We studied 264 IMA rings taken from 65 patients undergoing co...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1046/j.0306-5251.2001.01444.x

    authors: Liu MH,Floten SH,Yang Q,He GW

    更新日期:2001-09-01 00:00:00

  • The disposition and effects of two doses of dichloroacetate in adults with severe falciparum malaria.

    abstract::1 Dichloroacetate (DCA) is a promising treatment for lactic acidosis complicating severe malaria. The pharmacokinetics, pharmacodynamics and toxicity of dichloroacetate were evaluated in 11 patients with severe malaria, and their lactate responses compared with nine control patients in an open-label prospective study....

    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.1365-2125.1996.tb00155.x

    authors: Krishna S,Supanaranond W,Pukrittayakamee S,Kuile FT,Ruprah M,White NJ

    更新日期:1996-01-01 00:00:00

  • The use of a three compartment in vitro model to investigate the role of hepatic drug metabolism in drug-induced blood dyscrasias.

    abstract::1. N-hydroxylation is thought to be an essential step in the haemotoxicity of dapsone (DDS). To investigate both metabolism-dependent and cell-selective drug toxicity in vitro we have developed a three-compartment system in which an hepatic drug metabolizing system is contained within a central compartment separated b...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1993.tb05888.x

    authors: Tingle MD,Park BK

    更新日期:1993-07-01 00:00:00

  • Self treatment with one of three self selected, ultramolecular homeopathic medicines for the prevention of upper respiratory tract infections in children. A double-blind randomized placebo controlled trial.

    abstract:AIMS:Homeopathic medicines are frequently purchased over the counter (OTC). Respiratory complaints are the most frequent reason for such purchases. Children with upper respiratory tract infection (URTI) are frequent users of homeopathy. This study investigates the effect of self treatment with one of three self selecte...

    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.1365-2125.2005.02336.x

    authors: Steinsbekk A,Bentzen N,Fønnebø V,Lewith G

    更新日期:2005-04-01 00:00:00

  • Identification of the cytochrome P450 enzymes involved in the N-demethylation of sildenafil.

    abstract:AIMS:To characterize the cytochrome P450 (CYP) enzymes responsible for the N-demethylation of sildenafil to its main metabolite, UK-103 320, to investigate the potential inhibitory effects of sildenafil on CYP enzymes and to evaluate the potential of selected drugs to affect sildenafil metabolism. METHODS:The metaboli...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1046/j.1365-2125.2001.00318.x

    authors: Hyland R,Roe EG,Jones BC,Smith DA

    更新日期:2001-03-01 00:00:00

  • Effect of P-glycoprotein inhibition at the blood-brain barrier on brain distribution of (R)-[11 C]verapamil in elderly vs. young subjects.

    abstract:AIMS:The efflux transporter P-glycoprotein (ABCB1) acts at the blood-brain barrier (BBB) to restrict the distribution of many different drugs from blood to the brain. Previous data suggest an age-associated decrease in the expression and function of ABCB1 at the BBB. In the present study, we investigated the influence ...

    journal_title:British journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1111/bcp.13301

    authors: Bauer M,Wulkersdorfer B,Karch R,Philippe C,Jäger W,Stanek J,Wadsak W,Hacker M,Zeitlinger M,Langer O

    更新日期:2017-09-01 00:00:00

  • The first-in-human study of CNTO 7160, an anti-interleukin-33 receptor monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis.

    abstract:AIMS:To assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of CNTO 7160, an anti-interleukin-33 receptor (IL-33R) monoclonal antibody, in healthy subjects and patients with asthma or atopic dermatitis (AD). METHODS:In Part 1 of this Phase I, randomized, double-blind, placebo-c...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/bcp.14361

    authors: Nnane I,Frederick B,Yao Z,Raible D,Shu C,Badorrek P,van den Boer M,Branigan P,Duffy K,Baribaud F,Fink D,Yang TY,Xu Z

    更新日期:2020-12-01 00:00:00

  • Clinical metabolomics paves the way towards future healthcare strategies.

    abstract::Metabolomics is recognized as a powerful top-down system biological approach to understand genetic-environment-health paradigms paving new avenues to identify clinically relevant biomarkers. It is nowadays commonly used in clinical applications shedding new light on physiological regulatory processes of complex mammal...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章,评审

    doi:10.1111/j.1365-2125.2012.04216.x

    authors: Collino S,Martin FP,Rezzi S

    更新日期:2013-03-01 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

  • A comparison of the effects of hydrallazine, diazoxide, sodium nitrite and sodium nitroprusside on human isolated arteries and veins.

    abstract::1 Human common palmar digital arteries and dorsal metacarpal veins have been studied in vitro to investigate the responses of arterial and venous muscle to hydrallazine, diazoxide, nitroprusside and sodium nitrite. 2 Tissues were removed at autopsy, cut into helical strips and suspended in organ baths under identical ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1111/j.1365-2125.1981.tb01102.x

    authors: Moulds RF,Jauernig RA,Shaw J

    更新日期:1981-01-01 00:00:00

  • Human subcutaneous tissue distribution of fluconazole: comparison of microdialysis and suction blister techniques.

    abstract:AIMS:To investigate uptake of fluconazole into the interstitial fluid of human subcutaneous tissue using the microdialysis and suction blister techniques. METHODS:A sterile microdialysis probe (CMA/60) was inserted subcutaneously into the upper arm of five healthy volunteers following an overnight fast. Blisters were ...

    journal_title:British journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1046/j.1365-2125.2003.01930.x

    authors: Sasongko L,Williams KM,Day RO,McLachlan AJ

    更新日期:2003-11-01 00:00:00