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It's an inverse translation I was asked to do about a clinical trial study on drugs. Of course this is scientific writing, it involves terms and other issues. I'd be glad, though, if someone can help me with grammatic/syntactic errors or odd things. Thanks in advance!
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TITLE “A prospective single-blind, randomized, crossover, replicated, comparative study to establish bioequivalence of medroxyprogesterone 10 mg tablets on healthy subjects: XYZ Pharmaceuticals' Medroxi vs SCHMIEDEL Ltd's Provierot ®”
GLOSSARY AND LIST OF ABBREVIATIONS
A Absorption
AUC Area Under the Concentration Time Curve
AUC0? t Area Under the Concentration-Time Curve from Time Zero to Time of Last Sample Intake
AUC0? ? Area Under the Concentration-Time Curve from Time Zero to Infinity
CBC Complete Blood Count
REFERENCE PRODUCT: Schmiedel Ltd's Provierof ® TEST FORMULATION: XYZ Pharmaceuticals' (Mexico) Medroxi
1. AIMS To determine bioavailability of two medroxyprogesterone pharmaceutic specialties, one of them the reference product: (Drug A: Provierof ®) while the other is the test formulation: (Drug B: Medroxi), on healthy male subjects, in a 40 mg dose (4 tablets) taken orally, under fasting conditions of each examined products to establish its bioequivalence; all of this in order to register them as generics drugs through the trials required by the Official Mexican Standards and not through a demonstration of pharmacokinetic differences within genre populations.
1.1.1. Adverse effects Adverse effects related to use of medroxyprogesterone acetate are: pulmonary embolism, thrombophlebitis, increased platelets aggregate formation, nervousness, drowsiness, fatigue, alopecia, acne, hirsutism, depression, dizzyness, increased bleeding time, cephalalgia, abnormal uterine bleeding, amenorrhea, nausea, galactorrhea, overweight, increasing risk of breast cancer, increasing risk of bone fracture, and variable expression of delayed hypersensitivity (Goodman & Gilman 10th ed. and PDR 61). These drugs are classified under Category X —by FDA's Pregnancy Drug Classifications— due to an increased risk of fetal abnormalities (hypospadias, clitoris enlargement, and labial fusion). The margin of safety (MOS) is high (PDR 61).
1.2. Study's premature end • This study can be interrupted temporarily or discontinued permanently by Sponsor's, Chief Researcher's or Comisión de Ética e Investigación choice according to Mexican Secretariat of Health’s guidelines.
Abstract
TITLE OF STUDY A prospective single-blind, randomized, crossover, replicated, comparative study to establish bioequivalence of medroxyprogesterone 10 mg tablets on healthy subjects: XYZ's Medroxi vs SCHMIEDEL's Provierof ®
RESEARCH OBJECTIVES To compare bioavailability of two medroxyprogesterone commercial products (Provera® vs Medroxiprogesterone) and to establish their bioequivalence.
STUDY DESIGN An experimental, longitudinal, single-blind, comparative, randomized, crossover, ABBA and BAAB design.
POPULATION Thirty-six healthy male subjects and two surplus cases.
PACKAGING 10 mg tablets
DOSE Four tablets taken orally, after a period of 10 hour fasting.
PRETREATMENT Not required.
WASH-OUT TIME Seven days.
REQUIRED LABORATORY STUDIES Full biometrics, complete blood count (CBC, 4 profiles), liver function tests, HIV test, hepatitis B & C tests, VDRL blood test, urine drug test and also, in the case of women, a pregnancy test.
REFERENCE PRODUCT Schmiedel Ltd's Provierof ®
TEST FORMULATION XYZ Pharmaceuticals' (Mexico) Medroxi
ASSESSMENT PARAMETERS A 36 hour follow up in order to get sixteen blood samples, to determinate medroxiprogesterone within plasma and to calculate AUC0? t, AUC0? ?and Cmax.
SAMPLING INTERVALS 0.00 (Pre-treatment, Control), 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.50, 4.00, 6.00, 12.00, 24.00 and 36.00 hours after the treatment.
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1 Answer
TITLE “A prospective single-blind, randomized, crossover, replicated, comparative study to establish bioequivalence of medroxyprogesterone 10 mg tablets on healthy subjects: XYZ Pharmaceuticals' Medroxi vs SCHMIEDEL Ltd's Provierot ®”
GLOSSARY AND LIST OF ABBREVIATIONS
A Absorption
AUC Area Under the Concentration Time Curve
AUC0? t Area Under the Concentration-Time Curve from Time Zero to Time of Last Sample Intake
AUC0? ? Area Under the Concentration-Time Curve from Time Zero to Infinity
CBC Complete Blood Count
REFERENCE PRODUCT: Schmiedel Ltd's Provierof ® TEST FORMULATION: XYZ Pharmaceuticals' (Mexico) Medroxi
- AIMS To determine bioavailability of two medroxyprogesterone pharmaceutic specialties, one of them the reference product: (Drug A: Provierof ®) while the other is the test formulation: (Drug B: Medroxi), on healthy male subjects, in a 40 mg dose (4 tablets) taken orally, under fasting conditions of each examined products to establish its bioequivalence; all of this in order to register them as generics drugs through the trials required by the Official Mexican Standards and not through a demonstration of pharmacokinetic differences within genre populations.
1.1.1. Adverse effects Adverse effects related to use of medroxyprogesterone acetate are: pulmonary embolism, thrombophlebitis, increased platelets aggregate formation, nervousness, drowsiness, fatigue, alopecia, acne, hirsutism, depression, dizziness, increased bleeding time, cephalalgia, abnormal uterine bleeding, amenorrhea, nausea, galactorrhea, overweight, increased risk of breast cancer, increased risk of bone fracture, and variable expression of delayed hypersensitivity (Goodman & Gilman 10th ed. and PDR 61). These drugs are classified under Category X —by FDA's Pregnancy Drug Classifications— due to an increased risk of fetal abnormalities (hypospadias, clitoris enlargement, and labial fusion). The margin of safety (MOS) is high (PDR 61).
1.2. Study's premature end • This study can be interrupted temporarily or discontinued permanently by Sponsor's, Chief Researcher's or Comisión de Ética e Investigación choice according to Mexican Secretariat of Health’s guidelines.
Abstract
TITLE OF STUDY A prospective single-blind, randomized, crossover, replicated, comparative study to establish bioequivalence of medroxyprogesterone 10 mg tablets on healthy subjects: XYZ's Medroxi vs SCHMIEDEL's Provierof ®
RESEARCH OBJECTIVES To compare bioavailability of two medroxyprogesterone commercial products (Provera® vs Medroxiprogesterone) and to establish their bioequivalence.
STUDY DESIGN An experimental, longitudinal, single-blind, comparative, randomized, crossover, ABBA and BAAB design.
POPULATION Thirty-six healthy male subjects and two surplus cases.
PACKAGING 10 mg tablets
DOSE Four tablets taken orally, after a period of 10 hour fasting.
PRETREATMENT Not required.
WASH-OUT TIME Seven days.
REQUIRED LABORATORY STUDIES Full biometrics, complete blood count (CBC, 4 profiles), liver function tests, HIV test, hepatitis B & C tests, VDRL blood test, urine drug test and also, in the case of women, a pregnancy test.
REFERENCE PRODUCT Schmiedel Ltd's Provierof ®
TEST FORMULATION XYZ Pharmaceuticals' (Mexico) Medroxi
ASSESSMENT PARAMETERS A 36 hour follow up in order to get sixteen blood samples, to determinate medroxiprogesterone within plasma and to calculate AUC0? t, AUC0? ?and Cmax.
SAMPLING INTERVALS 0.00 (Pre-treatment, Control), 0.33, 0.66, 1.00, 1.33, 1.66, 2.00, 2.33, 2.66, 3.00, 3.50, 4.00, 6.00, 12.00, 24.00 and 36.00 hours after the treatment.
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