This site uses cookies.
Some of these cookies are essential to the operation of the site,
while others help to improve your experience by providing insights into how the site is being used.
For more information, please see the ProZ.com privacy policy.
This person has a SecurePRO™ card. Because this person is not a ProZ.com Plus subscriber, to view his or her SecurePRO™ card you must be a ProZ.com Business member or Plus subscriber.
Affiliations
This person is not affiliated with any business or Blue Board record at ProZ.com.
English to French: Plasma and Urine Pharmacokinetics General field: Medical Detailed field: Chemistry; Chem Sci/Eng
Source text - English Although the range of individual tmax values is large (0.25 to 4 h), XXX is more rapidly absorbed following doses up to 600 mg than following higher doses.
The terminal plasma half life is variable between subjects with individual values ranging from 6 to 11 h (intra subject differences did not exceed 2 hours except for subject 001 019).
The apparent total body clearance of XXX (58 mL/min/1.73 m2) is low when compared to the hepatic blood flow (1450 mL/min) (11) indicating a low extraction ratio by the liver.
The apparent volume of distribution (0.57 L/kg) is close to the volume of intra and extra cellular fluids (0.60 L/kg).
Only a small fraction (3 8%) of the dose is excreted as parent compound in the urine over 24 hours. Even if the renal excretion of XXX is not complete, the total amount to be recovered in the urine should be low. So the renal clearance of XXX is expected to account for 5-10% of the total body clearance. Consequently, non renal (i.e. metabolic) clearance is the major component of the total body clearance.
The renal clearance of XXX (4 mL/min) is much lower than the normal creatinine clearance (80 mL/min) indicating an intensive tubular reabsorption.
From the observed urinary metabolites, it appeared that the metabolism of XXX in human occurred by two initial pathways: by hydrolysis of the amide group (M9) and by monohydroxylation (M1a, M1b, M1c, M1d and M1e), with the monohydroxylation operating mainly in w1 on the propyl chain.
These primary metabolites were found to undergo subsequent metabolism by further oxidation to generate a carboxylic acid group on the propyl chain (M2), the ketone corresponding to M1a and M1b (M3) and a dihydroxylated metabolite (M4). For the metabolites M5a, M5b and M6 it was not possible to determine the sequence of biotransformation reactions : amide hydrolysis of the monohydroxylated metabolites (M5a and M5b) and the ketonic metabolite (M6) versus oxidation of the carboxylic acid metabolite (M9) issued from the amide hydrolysis.
To a lesser extent, the conjugation of M9 with taurine (M7) was also evidenced.
The configuration of XXX was observed to be stable in 12 24 h urine of subjects dosed with 1400 mg. Neither its diastereoisomers nor its enantiomer were observed.
Translation - French Bien que l’étendue des valeurs individuelles de tmax soit grande (0.25 à 4 h), XXX est plus rapidement absorbé après administration de doses allant jusqu’à 600 mg qu’après administration de doses plus élevées.
La demi vie plasmatique terminale entre sujets est variable avec des valeurs individuelles allant de 6 à 11 h (les différences intra sujet n’excèdent pas 2 heures, excepté pour le sujet 001 019).
La clairance corporelle totale apparente de XXX (58 ml/min/1.73 m2) est faible comparé au débit hépatique sanguin (1450 ml/min) (11), ce qui indique un faible ratio d’extraction hépatique.
Le volume apparent de distribution (0.57 L/kg) est proche des volumes intra et extra cellulaires (0.60 L/kg).
Seule une petite fraction (3 8%) de la dose est excrétée sous la forme du produit parent dans l’urine en 24 heures. Même si l’excrétion rénale de XXX n’est pas complète, la quantité totale pouvant être retrouvée dans l’urine devrait être faible. Donc la clairance rénale attendue pour XXX devrait représenter 5-10% de la clairance corporelle totale. En conséquence, la clairance non rénale (c.à.d. métabolique) est la composante majeure de la clairance corporelle totale.
La clairance rénale de XXX (4 ml/min) est bien plus faible que la clairance à la créatinine normale (80 ml/min) ce qui indique une réabsorption tubulaire intensive.
Par l’étude des métabolites urinaires, il est apparu que le métabolisme humain de XXX suit deux voies métaboliques initiales : par hydrolyse du groupe amide (M9) et par mono hydroxylation (M1a, M1b, M1c, M1d and M1e), la mono hydroxylation survenant principalement en w1 sur la chaine propyle.
Ces métabolites primaires subissent une étape métabolique supplémentaire par oxydation qui génère un groupe acide carboxylique sur la chaine propyle (M2), la forme cétone correspondant à M1a and M1b (M3) et un métabolite di hydroxylé (M4). Pour les métabolites M5a, M5b et M6, il ne fut pas possible de déterminer la séquence des réactions de biotransformation : soit hydrolyse amide des métabolites mono hydroxylés (M5a and M5b) et du métabolite cétonique (M6), soit oxydation du métabolite acide carboxylique (M9) issu de l’hydrolyse amide.
Dans une moindre mesure, la conjugation de M9 avec la taurine (M7) fut aussi mis en évidence.
La configuration de XXX fut trouvée stable dans les urines 12 24 h des sujets ayant reçu une dose de 1400 mg. Ni ses diastéréoisomères ni ses énantiomères ne furent observés.
More
Less
Experience
Years of experience: 33. Registered at ProZ.com: Dec 2011.
French to English (20 years work in transnational pharma company) English to French (20 years working for a transnational pharma compan)
Memberships
N/A
Software
Adobe Acrobat, Microsoft Excel, Microsoft Office Pro, Microsoft Word, Powerpoint
CV/Resume
CV available upon request
Bio
SERVICES
• translation of clinical trial documents: protocols, patient informed consents, reports, investigator brochures
• translation of pre-clinical study documents: study plans, procedures, reports, safety data sheets, validation reports, experimental method reports.
• Exact meaning and text accuracy are paramount. As far as my goals, they come first.
• I will provide you with a concise style, recognised as efficient and attractive. I always show attention to detail, perfectionism and intense curiosity, together with the respect of quality and deadlines.
I hold a M.Sc. in Analytical Chemistry and a Doctor of Pharmacy degree. Owing to my background (5 years work in hospitals, 20 years work in a transnational pharma company), I am:
• familiar with working with scientists from various fields of activity, notably chemistry, veterinary medicine, pharmaceutical development and clinical trials.
• familiar with the general laboratory equipment and the techniques associated to analytical chemistry, histology, biochemistry, laboratory animal handling (rodents and mammals), molecular biology, PCR, etc.
• I always show attention to detail, perfectionism and intense curiosity, together with the respect of quality and deadlines.
This user has earned KudoZ points by helping other translators with PRO-level terms. Click point total(s) to see term translations provided.
