Repandin Actions

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Actions of Repandin in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Oral antidiabetic agent.

Pharmacology: Repandin is a novel short-acting oral secretagogue. Repandin lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β-cells in the pancreatic islets.

Repandin closes ATP-dependent potassium channels in the β-cell membrane via a target protein different from other secretagogues. This depolarises the β-cell and leads to an opening of the calcium channels with a resulting increase in calcium influx. This induces insulin secretion from the β-cell.

Pharmacokinetics: Repandin is rapidly absorbed from the GI tract with a rapid increase in the plasma concentration of the drug. The peak plasma level occurs within 1 hr post-administration. After reaching the peak, the plasma level decreases rapidly and is eliminated within 4-6 hrs. The plasma elimination half-life is approximately 1 hr. Repandin is >98% bound to plasma proteins in humans. Repandin is almost completely metabolised and no metabolites with clinically relevant hypoglycaemic effect have been identified. Repandin and its metabolites are excreted primarily via the bile. A small fraction of <8% of the administered dose appears in the urine primarily as metabolites. Less than 1% of the parent drug is recovered in the faeces.

How should I take Repandin?

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Repandin usually is taken 15 minutes before a meal but may be taken up to 30 minutes before a meal.

Dosing

The dose of Repandin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Repandin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

Call your doctor or pharmacist for instructions.

You should skip a dose of Repandin if a meal is skipped and add a dose of Repandin if you eat an extra meal.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Repandin administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Oral: Administer within 30 minutes before meals; may be administered preprandially 2, 3, or 4 times/day in response to changes in meal pattern. If a meal is missed, do not administer next scheduled dose; if hypoglycemia occurs, reduce dose.

Repandin pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Mechanism of Action

Repandin lowers blood glucose levels by stimulating the release of insulin from the pancreas. This action is dependent upon functioning beta (ß) cells in the pancreatic islets. Insulin release is glucose-dependent and diminishes at low glucose concentrations.

Repandin closes ATP-dependent potassium channels in the ß-cell membrane by binding at characterizable sites. This potassium channel blockade depolarizes the ß-cell, which leads to an opening of calcium channels. The resulting increased calcium influx induces insulin secretion. The ion channel mechanism is highly tissue selective with low affinity for heart and skeletal muscle.

Pharmacokinetics

Absorption

After oral administration, Repandin is rapidly and completely absorbed from the gastrointestinal tract. After single and multiple oral doses in healthy subjects or in patients, peak plasma drug levels (Cmax) occur within 1 hour (Tmax). Repandin is rapidly eliminated from the blood stream with a half-life of approximately 1 hour. The mean absolute bioavailability is 56%. When Repandin was given with food, the mean Tmax was not changed, but the mean Cmax and AUC (area under the time/plasma concentration curve) were decreased 20% and 12.4%, respectively.

Distribution

After intravenous (IV) dosing in healthy subjects, the volume of distribution at steady state (Vss) was 31 L, and the total body clearance (CL) was 38 L/h. Protein binding and binding to human serum albumin was greater than 98%.

Metabolism

Repandin is completely metabolized by oxidative biotransformation and direct conjugation with glucuronic acid after either an IV or oral dose. The major metabolites are an oxidized dicarboxylic acid (M2), the aromatic amine (M1), and the acyl glucuronide (M7). The cytochrome P-450 enzyme system, specifically 2C8 and 3A4, have been shown to be involved in the N-dealkylation of Repandin to M2 and the further oxidation to M1. Metabolites do not contribute to the glucose-lowering effect of Repandin.

Repandin appears to be a substrate for active hepatic uptake transporter (organic anion transporting protein OATP1B1).

Excretion

Within 96 hours after dosing with 14C-Repandin as a single, oral dose, approximately 90% of the radiolabel was recovered in the feces and approximately 8% in the urine. Only 0.1% of the dose is cleared in the urine as parent compound. The major metabolite (M2) accounted for 60% of the administered dose. Less than 2% of parent drug was recovered in feces.

Pharmacokinetic Parameters

The pharmacokinetic parameters of Repandin obtained from a single-dose, crossover study in healthy subjects and from a multiple-dose, parallel, dose-proportionality (0.5, 1, 2 and 4 mg) study in patients with type 2 diabetes are summarized in the following table:

Parameter Patients with Type 2 Diabetesa
a: dosed preprandially with three meals

CL = total body clearance

Vss = volume of distribution at steady state

AbsBio = absolute bioavailability

Dose

0.5 mg

1 mg

2 mg

4 mg

AUC0-24 hr Mean ±SD

(ng/mL*hr):

68.9 ± 154.4

125.8 ± 129.8

152.4 ± 89.6

447.4 ± 211.3

Dose

0.5 mg

1 mg

2 mg

4 mg

Cmax0-5 hr Mean ±SD

(ng/mL):

9.8 ± 10.2

18.3 ± 9.1

26 ± 13

65.8 ± 30.1

Dose

0.5 - 4 mg

Tmax0-5 hr Means (SD)

1 - 1.4 (0.3 - 0.5) hr

Dose

0.5 - 4 mg

T½ Means (IndRange)

1 - 1.4 (0.4 - 8) hr

Parameter

Healthy Subjects

CL based on i.v.

38 ± 16 L/hr

Vss based on i.v.

31 ± 12 L

AbsBio

56 ± 9%

These data indicate that Repandin did not accumulate in serum. Clearance of oral Repandin did not change over the 0.5 to 4 mg dose range, indicating a linear relationship between dose and plasma drug levels.

Variability of Exposure

Repandin AUC after multiple doses of 0.25 to 4 mg with each meal varies over a wide range. The intra-individual and inter-individual coefficients of variation were 36% and 69%, respectively. AUC over the therapeutic dose range included 69 to 1005 ng/mL*hr, but AUC exposure up to 5417 ng/mL*hr was reached in dose escalation studies without apparent adverse consequences.

Special Populations

Geriatric

Healthy volunteers were treated with a regimen of 2 mg taken before each of 3 meals. There were no significant differences in Repandin pharmacokinetics between the group of patients <65 years of age and a comparably sized group of patients ≥65 years of age.

Pediatric

No studies have been performed in pediatric patients.

Gender

A comparison of pharmacokinetics in males and females showed the AUC over the 0.5 mg to 4 mg dose range to be 15% to 70% higher in females with type 2 diabetes. This difference was not reflected in the frequency of hypoglycemic episodes (male: 16%; female: 17%) or other adverse events. With respect to gender, no change in general dosage recommendation is indicated since dosage for each patient should be individualized to achieve optimal clinical response.

Race

No pharmacokinetic studies to assess the effects of race have been performed, but in a U.S. 1-year study in patients with type 2 diabetes, the blood glucose-lowering effect was comparable between Caucasians (n=297) and African-Americans (n=33). In a U.S. dose-response study, there was no apparent difference in exposure (AUC) between Caucasians (n=74) and Hispanics (n=33).

Drug-Drug Interactions

Drug interaction studies performed in healthy volunteers show that Repandin had no clinically relevant effect on the pharmacokinetic properties of digoxin, theophylline, or warfarin. Coadministration of cimetidine with Repandin did not significantly alter the absorption and disposition of Repandin.

Additionally, the following drugs were studied in healthy volunteers with coadministration of Repandin. Listed below are the results:

CYP2C8 and CYP3A4 Inhibitors/Inducer

Gemfibrozil and Itraconazole

Coadministration of gemfibrozil (600 mg) and a single dose of 0.25 mg Repandin (after 3 days of twice-daily 600 mg gemfibrozil) resulted in an 8.1-fold higher Repandin AUC and prolonged Repandin half-life from 1.3 to 3.7 hr. Co­administration with itraconazole and a single dose of 0.25 mg Repandin (on the third day of a regimen of 200 mg initial dose, twice-daily 100 mg itraconazole) resulted in a 1.4-fold higher Repandin AUC. Coadministration of both gemfibrozil and itraconazole with Repandin resulted in a 19-fold higher Repandin AUC and prolonged Repandin half-life to 6.1 hr. Plasma Repandin concentration at 7 h increased 28.6-fold with gemfibrozil coadministration and 70.4-fold with the gemfibrozil-itraconazole combination.

Fenofibrate

Coadministration of 200 mg fenofibrate with a single dose of 0.25 mg Repandin (after 5 days of once daily fenofibrate 200 mg) resulted in unchanged AUC and Cmax values for both drugs.

Ketoconazole

Coadministration of 200 mg ketoconazole and a single dose of 2 mg Repandin (after 4 days of once daily ketoconazole 200 mg) resulted in a 15% and 16% increase in Repandin AUC and Cmax, respectively. The increases were from 20.2 ng/mL to 23.5 ng/mL for Cmax and from 38.9 ng/mL*hr to 44.9 ng/mL*hr for AUC.

Trimethoprim

Coadministration of 160 mg trimethoprim and a single dose of 0.25 mg Repandin (after 2 days of twice daily and one dose on the third day of trimethoprim 160 mg) resulted in a 61% and 41% increase in Repandin AUC and Cmax, respectively. The increase in AUC was from 5.9 ng/mL*hr to 9.6 ng/mL*hr and the increase in Cmax was from 4.7 ng/mL to 6.6 ng/mL.

Cyclosporine

Coadministration of 100 mg cyclosporine with a single dose of 0.25 mg Repandin (after two 100 mg doses of cyclosporine twelve hours apart) increased the Repandin (0.25 mg) Cmax 1.8-fold and the AUC 2.5-fold in an interaction study with healthy volunteers.

Rifampin

Coadministration of 600 mg rifampin and a single dose of 4 mg Repandin (after 6 days of once daily rifampin 600 mg) resulted in a 32% and 26% decrease in Repandin AUC and Cmax, respectively. The decreases were from 40.4 ng/mL to 29.7 ng/mL for Cmax and from 56.8 ng/mL*hr to 38.7 ng/mL*hr for AUC.

In another study, coadministration of 600 mg rifampin and a single dose of 4 mg Repandin (after 6 days of once daily rifampin 600 mg) resulted in a 48% and 17% decrease in Repandin median AUC and median Cmax respectively. The median decreases were from 54 ng/mL*hr to 28 ng/mL*hr for AUC and from 35 ng/mL to 29 ng/mL for Cmax. Repandin administered by itself (after 7 days of once daily rifampin 600 mg) resulted in an 80% and 79% decrease in Repandin median AUC and Cmax respectively. The decreases were from 54 ng/mL*hr to 11 ng/mL*hr for AUC and from 35 ng/mL to 7.5 ng/mL for Cmax.

Levonorgestrel & Ethinyl Estradiol

Coadministration of a combination tablet of 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol administered once daily for 21 days with 2 mg Repandin administered three times daily (days 1 to 4) and a single dose on Day 5 resulted in 20% increases in Repandin, levonorgestrel, and ethinyl estradiol Cmax. The increase in Repandin Cmax was from 40.5 ng/mL to 47.4 ng/mL. Ethinyl estradiol AUC parameters were increased by 20%, while Repandin and levonorgestrel AUC values remained unchanged.

Simvastatin

Coadministration of 20 mg simvastatin and a single dose of 2 mg Repandin (after 4 days of once daily simvastatin 20 mg and three times daily Repandin 2 mg) resulted in a 26% increase in Repandin Cmax from 23.6 ng/mL to 29.7 ng/mL. AUC was unchanged.

Nifedipine

Coadministration of 10 mg nifedipine with a single dose of 2 mg Repandin (after 4 days of three times daily nifedipine 10 mg and three times daily Repandin 2 mg) resulted in unchanged AUC and Cmax values for both drugs.

Clarithromycin

Coadministration of 250 mg clarithromycin and a single dose of 0.25 mg Repandin (after 4 days of twice daily clarithromycin 250 mg) resulted in a 40% and 67% increase in Repandin AUC and Cmax, respectively. The increase in AUC was from 5.3 ng/mL*hr to 7.5 ng/mL*hr and the increase in Cmax was from 4.4 ng/mL to 7.3 ng/mL.

Deferasirox

Coadministration of deferasirox (30 mg/kg/day for 4 days) and Repandin (single dose of 0.5 mg) resulted in an increase in Repandin systemic exposure (AUC) to 2.3-fold of control and an increase in Cmax of 62%.

Renal Insufficiency

Single-dose and steady-state pharmacokinetics of Repandin were compared between patients with type 2 diabetes and normal renal function (CrCl > 80 mL/min), mild to moderate renal function impairment (CrCl = 40 to 80 mL/min), and severe renal function impairment (CrCl = 20 to 40 mL/min). Both AUC and Cmax of Repandin were similar in patients with normal and mild to moderately impaired renal function (mean values 56.7 ng/mL*hr vs. 57.2 ng/mL*hr and 37.5 ng/mL vs. 37.7 ng/mL, respectively.) Patients with severely reduced renal function had elevated mean AUC and Cmax values (98 ng/mL*hr and 50.7 ng/mL, respectively), but this study showed only a weak correlation between Repandin levels and creatinine clearance. Initial dose adjustment does not appear to be necessary for patients with mild to moderate renal dysfunction. However, patients with type 2 diabetes who have severe renal function impairment should initiate Repandin therapy with the 0.5 mg dose – subsequently, patients should be carefully titrated. Studies were not conducted in patients with creatinine clearances below 20 mL/min or patients with renal failure requiring hemodialysis.

Hepatic Insufficiency

A single-dose, open-label study was conducted in 12 healthy subjects and 12 patients with chronic liver disease (CLD) classified by Child-Pugh scale and caffeine clearance. Patients with moderate to severe impairment of liver function had higher and more prolonged serum concentrations of both total and unbound Repandin than healthy subjects (AUChealthy: 91.6 ng/mL*hr; AUCCLD patients: 368.9 ng/mL*hr; Cmax, healthy: 46.7 ng/mL; Cmax, CLD patients: 105.4 ng/mL). AUC was statistically correlated with caffeine clearance. No difference in glucose profiles was observed across patient groups. Patients with impaired liver function may be exposed to higher concentrations of Repandin and its associated metabolites than would patients with normal liver function receiving usual doses. Therefore, Repandin should be used cautiously in patients with impaired liver function. Longer intervals between dose adjustments should be utilized to allow full assessment of response.

Clinical Trials

Monotherapy Trials

A four-week, double-blind, placebo-controlled dose-response trial was conducted in 138 patients with type 2 diabetes using doses ranging from 0.25 to 4 mg taken with each of three meals. Repandin therapy resulted in dose-proportional glucose lowering over the full dose range. Plasma insulin levels increased after meals and reverted toward baseline before the next meal. Most of the fasting blood glucose-lowering effect was demonstrated within 1 to 2 weeks.

In a double-blind, placebo-controlled, 3-month dose titration study, Repandin or placebo doses for each patient were increased weekly from 0.25 mg through 0.5, 1, and 2 mg, to a maximum of 4 mg, until a fasting plasma glucose (FPG) level <160 mg/dL was achieved or the maximum dose reached. The dose that achieved the targeted control or the maximum dose was continued to end of study. FPG and 2-hour post-prandial glucose (PPG) increased in patients receiving placebo and decreased in patients treated with Repandin. Differences between the Repandin- and placebo-treated groups were -61 mg/dL (FPG) and -104 mg/dL (PPG). The between-group change in HbA1c, which reflects long-term glycemic control, was 1.7% units.

Repandin vs. Placebo Treatment: Mean FPG, PPG, and HbA1c Changes from baseline after 3 months of treatment:
FPG (mg/dL) PPG (mg/dL) HbA1c (%)
PL R PL R PL R
FPG = fasting plasma glucose

PPG = post-prandial glucose

PL = placebo (N=33)

R = Repandin (N=66)

*: p< 0.05 for between group difference

Baseline

215.3

220.2

245.2

261.7

8.1

8.5

Change from Baseline (at last visit)

30.3

-31*

56.5

-47.6*

1.1

-0.6*

Another double-blind, placebo-controlled trial was carried out in 362 patients treated for 24 weeks. The efficacy of 1 and 4 mg preprandial doses was demonstrated by lowering of fasting blood glucose and by HbA1c at the end of the study. HbA1c for the Repandin-treated groups (1 and 4 mg groups combined) at the end of the study was decreased compared to the placebo-treated group in previously naïve patients and in patients previously treated with oral hypoglycemic agents by 2.1% units and 1.7% units, respectively. In this fixed-dose trial, patients who were naïve to oral hypoglycemic agent therapy and patients in relatively good glycemic control at baseline (HbA1c below 8%) showed greater blood glucose-lowering including a higher frequency of hypoglycemia. Patients who were previously treated and who had baseline HbA1c ≥ 8% reported hypoglycemia at the same rate as patients randomized to placebo. There was no average gain in body weight when patients previously treated with oral hypoglycemic agents were switched to Repandin. The average weight gain in patients treated with Repandin and not previously treated with sulfonylurea drugs was 3.3%.

The dosing of Repandin relative to meal-related insulin release was studied in three trials including 58 patients. Glycemic control was maintained during a period in which the meal and dosing pattern was varied (2, 3 or 4 meals per day; before meals x 2, 3, or 4) compared with a period of 3 regular meals and 3 doses per day (before meals x 3). It was also shown that Repandin can be administered at the start of a meal, 15 minutes before, or 30 minutes before the meal with the same blood glucose-lowering effect.

Repandin was compared to other insulin secretagogues in 1-year controlled trials to demonstrate comparability of efficacy and safety. Hypoglycemia was reported in 16% of 1228 Repandin patients, 20% of 417 glyburide patients, and 19% of 81 glipizide patients. Of Repandin-treated patients with symptomatic hypoglycemia, none developed coma or required hospitalization.

Combination Trials

Repandin was studied in combination with metformin in 83 patients not satisfactorily controlled on exercise, diet, and metformin alone. Repandin dosage was titrated for 4 to 8 weeks, followed by a 3-month maintenance period. Combination therapy with Repandin and metformin resulted in significantly greater improvement in glycemic control as compared to Repandin or metformin monotherapy. HbA1c was improved by 1% unit and FPG decreased by an additional 35 mg/dL. In this study where metformin dosage was kept constant, the combination therapy of Repandin and metformin showed dose-sparing effects with respect to Repandin. The greater efficacy response of the combination group was achieved at a lower daily Repandin dosage than in the Repandin monotherapy group.

Repandin and Metformin Therapy: Mean Changes from Baseline in Glycemic Parameters and Weight after 4 to 5 Months of Treatment1
1: based on intent-to-treat analysis

*: p< 0.05, for pairwise comparisons with Repandin and metformin.

#: p< 0.05, for pairwise comparison with metformin.

Repandin

Combination

Metformin

N

28

27

27

Median Final Dose (mg/day)

12

6 (Repandin)

1500 (metformin)

1500

HbA1c (% units)

-0.38

-1.41*

-0.33

FPG (mg/dL)

8.8

-39.2*

-4.5

Weight (kg)

3

2.4#

-0.9

A combination therapy regimen of Repandin and pioglitazone was compared to monotherapy with either agent alone in a 24-week trial that enrolled 246 patients previously treated with sulfonylurea or metformin monotherapy (HbA1c > 7%). Numbers of patients treated were: Repandin (N = 61), pioglitazone (N = 62), combination (N = 123). Repandin dosage was titrated during the first 12 weeks, followed by a 12-week maintenance period. Combination therapy resulted in significantly greater improvement in glycemic control as compared to monotherapy (figure below). The changes from baseline for completers in FPG (mg/dL) and HbA1c (%), respectively were: -39.8 and -0.1 for Repandin, -35.3 and -0.1 for pioglitazone and -92.4 and -1.9 for the combination. In this study where pioglitazone dosage was kept constant, the combination therapy group showed dose-sparing effects with respect to Repandin. The greater efficacy response of the combination group was achieved at a lower daily Repandin dosage than in the Repandin monotherapy group. Mean weight increases associated with combination, Repandin and pioglitazone therapy were 5.5 kg, 0.3 kg, and 2 kg respectively.

HbA1c Values from Repandin/Pioglitazone Combination Study

HbA1c values by study week for patients who completed study (combination, N = 101; Repandin, N = 35, pioglitazone, N = 26).

Subjects with FPG above 270 mg/dL were withdrawn from the study.

Pioglitazone dose: fixed at 30 mg/day; Repandin median final dose: 6 mg/day for combination and 10 mg/day for monotherapy.

A combination therapy regimen of Repandin and rosiglitazone was compared to monotherapy with either agent alone in a 24-week trial that enrolled 252 patients previously treated with sulfonylurea or metformin (HbA1c > 7%). Combination therapy resulted in significantly greater improvement in glycemic control as compared to monotherapy (table below). The glycemic effects of the combination therapy were dose-sparing with respect to both total daily Repandin dosage and total daily rosiglitazone dosage. A greater efficacy response of the combination therapy group was achieved with half the median daily dose of Repandin and rosiglitazone, as compared to the respective monotherapy groups. Mean weight change associated with combination therapy was greater than that of Repandin monotherapy.

Mean Changes from Baseline in Glycemic Parameters and Weight in a 24-Week Repandin/Rosiglitazone Combination Study1
Repandin Combination Rosiglitazone
1: based on intent-to-treat analysis

*: p-value ≤ 0.001 for comparison to either monotherapy

#: p-value < 0.001 for comparison to Repandin

N

63

127

62

HbA1c (%)

Baseline

9.3

9.1

9

Change by 24 weeks

-0.17

-1.43*

-0.56

FPG (mg/dL)

Baseline

269

257

252

Change by 24 weeks

-54

-94*

-67

Change in Weight (kg)

+1.3

+4.5#

+3.3

Final median doses: rosiglitazone - 4 mg/day for combination and 8 mg/day for monotherapy; Repandin - 6 mg/day for combination and 12 mg/day for monotherapy.


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References

  1. DailyMed. "REPAGLINIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. NCIt. "Repaglinide: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
  3. EPA DSStox. "Repaglinide: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).

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