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Bile Acid Oral Dissolution Therapy

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1. Bile Acid Oral Dissolution Therapy

Bile Acid Oral Dissolution Therapy Bile Acid Oral Dissolution Therapy Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Bile Acid Oral (...) Dissolution Therapy Bile Acid Oral Dissolution Therapy Aka: Bile Acid Oral Dissolution Therapy , Ursodeoxycholic Acid , Ursodiol , Actigal , Chenodeoxycholic Acid , Oral Dissolution Therapy , Gallstone Dissolving Agent II. Mechanism Decreases biliary hepatic secretion Forms unsaturated bile Promotes dissolution of crystals and s III. Indication: Cholelithiasis Comorbid condition that precludes safe and symptomatic s Symptomatic patient unwilling to undergo surgery Small s (<5mm) with functioning

2018 FP Notebook

2. Bile Acid Oral Dissolution Therapy

Bile Acid Oral Dissolution Therapy Bile Acid Oral Dissolution Therapy Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Bile Acid Oral (...) Dissolution Therapy Bile Acid Oral Dissolution Therapy Aka: Bile Acid Oral Dissolution Therapy , Ursodeoxycholic Acid , Ursodiol , Actigal , Chenodeoxycholic Acid , Oral Dissolution Therapy , Gallstone Dissolving Agent II. Mechanism Decreases biliary hepatic secretion Forms unsaturated bile Promotes dissolution of crystals and s III. Indication: Cholelithiasis Comorbid condition that precludes safe and symptomatic s Symptomatic patient unwilling to undergo surgery Small s (<5mm) with functioning

2015 FP Notebook

3. Statistical investigation of simulated fed intestinal media composition on the equilibrium solubility of oral drugs Full Text available with Trip Pro

Statistical investigation of simulated fed intestinal media composition on the equilibrium solubility of oral drugs Gastrointestinal fluid is a complex milieu and it is recognised that gut drug solubility is different to that observed in simple aqueous buffers. Simulated gastrointestinal media have been developed covering fasted and fed states to facilitate in vitro prediction of gut solubility and product dissolution. However, the combination of bile salts, phospholipids, fatty acids (...) results for other simulated fed gastrointestinal media systems or human intestinal fluid samples. For acidic drugs the influence of pH predominates but other significant factors related to oleate and bile salt or interactions between them are present. For basic drugs pH, oleate and bile salt have equal significance along with interactions between pH and oleate and lecithin and oleate. Neutral drugs show diverse effects of the media components particularly with regard to oleate, bile salt, pH

2017 European Journal of Pharmaceutical Sciences

4. Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol

Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment Official Title: Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study Study Start Date : October 2014 Actual Primary Completion Date : October 2015 Actual Study Completion Date : October 2015 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment (...) Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before

2014 Clinical Trials

5. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

-hydroxymethyl-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol. Ertugliflozin is included in the drug product as a cocrystal with L-pyroglutamic acid (L-PGA), known as ertugliflozin L- PGA. Ertugliflozin is formulated as an immediate-release tablet for oral administration at 5 and 15 mg Assessment report EMA/86938/2018 Page 10/139 strengths. The tablets are manufactured with a conventional direct compression process, utilizing conventional excipients and common blend (5% active). Dose strengths are expressed (...) Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 25 January 2018 EMA/86938/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report

2018 European Medicines Agency - EPARs

6. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

Concentration L-PGA L-pyroglutamic acid LS least-squares MACE major adverse cardiovascular event MAR missing at random MNAR missing-not-at-random assumption MCAR missing completely at random MedDRA Medical Dictionary for Regulatory Activities mFAS modified FAS NDA New Drug Application NIR near infrared NMR nuclear magnetic resonance NMT not more than NOEC No Observed Effect Concentration PA polyamide PAR proven acceptable ranges PAT process analytical technology PD pharmacodynamic(s) PDLC pre-defined limit (...) contraindications to metformin. Subsequently, if the A1C target is not achieved after approximately 3 months, therapy should be augmented to a 2-drug combination followed by the addition of other AHAs approximately every 3 months if the A1C goal is not achieved. Despite the availability of a broad array of AHAs, only approximately half of patients with T2DM achieve glycaemic control per treatment guidelines. Furthermore, while new classes of AHA medications have been introduced over the last decade

2018 European Medicines Agency - EPARs

7. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

Adsorption distribution coefficient normalized to organic content in matrix KF Karl Fischer KOH potassium hydroxide LDL-C low density lipoprotein-cholesterol LDPE low density polyethylene LOEC Lowest Observed Effect Concentration L-PGA L-pyroglutamic acid LS Least-squares MACE Major adverse cardiovascular event MedDRA Medical Dictionary for Regulatory Activities met metformin mFAS modified FAS MNAR missing-not-at-random assumption NDA New Drug Application NIR near infrared NMR nuclear magnetic resonance (...) (T2DM). It possesses a high selectivity for SGLT2 versus SGLT1 and other glucose transporters (GLUT1-4). Ertugliflozin is a new chemical entity with a chemical name of (1S,2S,3S,4R,5S)-5-[4-Chloro-3- (4- ethoxybenzyl)phenyl]-1-hydroxymethyl-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol. Ertugliflozin is included in the drug product as a cocrystal with L-pyroglutamic acid (L-PGA), known as ertugliflozin L- PGA. Ertugliflozin is formulated as an immediate-release tablet for oral administration at 5 and 15

2018 European Medicines Agency - EPARs

8. Effect of Oral Chenodeoxycholic Acid on Bile Acid Kinetics and Biliary Lipid Composition in Women with Cholelithiasis Full Text available with Trip Pro

Effect of Oral Chenodeoxycholic Acid on Bile Acid Kinetics and Biliary Lipid Composition in Women with Cholelithiasis Bile acid kinetics and biliary lipid composition were characterized in six women with gallstones before and after 6 mo of oral therapy with chenodeoxycholic acid, an agent that induces dissolution of cholesterol gallstones in man. Over a dosage range of 1-4 g/day, absorption varied from 0.8 to 2.3 g/day. The chenodeoxycholic acid pool expanded two-to sixfold, and bile became (...) patients, whose bile was unsaturated, it remained so. In five patients with radiolucent gallstones, chenodeoxycholic acid therapy was continued after completion of kinetic and composition measurements; the stones decreased in size or dissolved entirely during the subsequent 6 to 18 mo. Similar measurements of bile acid kinetics and biliary lipid composition were made before and after a 6-mo period without medication in a control group of six healthy women; no changes occurred.

1973 Journal of Clinical Investigation

9. Brilinta (ticagrelor) Tablets - medical review

Brilinta (ticagrelor) Tablets - medical review CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022433Orig1s000 MEDICAL REVIEW(S) DIVISION OF CARDIOVASCULAR AND RENAL PRODUCTS Complete Response Review Addendum Sponsor Safety Reporting Submissions: NDA 22-433 and IND 65,808 SD 632 Drug: ticagrelor (Brilinta™) Indication: reduce the rate of thrombotic events in patients with acute coronary syndromes (ACS) Sponsor: AstraZeneca Review date: June 8, 2011 Reviewer: Thomas A. Marciniak, M.D (...) might argue that the individual SUSARs as in these examples are impossible to interpret individually. However, all of them fall into the “(C)” category described in the CFR: “(C) An aggregate analysis of specific events observed in a clinical trial (such as known consequences of the underlying disease or condition under investigation or other events that commonly occur in the study population independent of drug therapy) that indicates those events occur more frequently in the drug treatment group

2011 FDA - Drug Approval Package

10. Chenodeoxycholic acid sigma-tau - cerebrotendinous xanthomatosis

CDCA and other medicines originate from the use of CDCA in dissolution of gallstones. CDCA is known to bind with colestyramine, colestipol (both bile acid sequestrants) or antacid drugs containing aluminium hydroxide and/or smectite (aluminium oxide) in the intestine, thus preventing its reabsorption and efficacy. Consequently, the above listed medicines should not be administered together with CDCA. Additionally, oral contraceptives, drugs containing oestrogens and clofibrate may increase (...) retrospective studies and was supported by literature review. No studies have been performed to determine the pharmacokinetic characteristics of chenodeoxycholic acid. The applicant has provided a literature review of bile acid kinetics and referred to the data available for the reference medicinal product. GCP The Clinical trials were performed in accordance with GCP as claimed by the applicant. Table 2: Overview of clinical studies 2.4.2. Pharmacokinetics Absorption Orally administered bile acids

2017 European Medicines Agency - EPARs

11. Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans

, 2017 Last Update Posted : August 10, 2018 See Sponsor: Vanderbilt University Medical Center Information provided by (Responsible Party): Michael Dole, Vanderbilt University Medical Center Study Details Study Description Go to Brief Summary: This project will evaluate distal intestinal bile salt administration in humans by deliving ursodeoxycholic acid (UDCA) into the terminal ileum of subjects with a pre-existing ileostomy and assessing several hormone levels following an oral glucose tolerance (...) Documented/known diagnosis of type 1 diabetes or type 2 diabetes, chronic liver disease, chronic kidney disease, heart failure, cardiac dysrhythmias, or familial hypercholesterolemia Current use of any over-the-counter or prescription oral bile salt Currently pregnant Current use of medications that are known to interact with Ursodiol Current or former smoker within the last year. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your

2017 Clinical Trials

12. Kolbam - cholic acid

of Regulation (EC) No 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 29 May 2009. Cholic acid FGK, was designated as an orphan medicinal product EU/3/09/683 on 9 December 2011 in the following indication: Treatment of inborn errors of primary bile acid synthesis responsive to treatment with cholic acid. At the time of designation, inborn errors in primary bile acid synthesis responsive to treatment with cholic acid affected approximately 0.07 in 10,000 people (...) in the European Union (EU). Following the CHMP positive opinion on this marketing authorisation, the Committee for Orphan Medicinal Products (COMP) reviewed the designation of Kolbam as an orphan medicinal product in the approved indication. The outcome of the COMP review can be found on the Agency's website: ema.europa.eu/Find medicine/Rare disease designations. The applicant applied for the following indications: Cholic acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis

2015 European Medicines Agency - EPARs

13. Orphacol - cholic acid

in severely affected cases is liver transplant. Currently there is no causal treatment. Treatment is limited to correcting the biochemical abnormalities, including the administration of bile acids and vitamin preparations. No medicinal product containing cholic acid as sole active substance has a marketing authorisation in the EU. Oral administration of cholic acid, the substance missing in affected patients, inhibits the production of the hepatotoxic bile acid precursors by down-regulating cholesterol 7a (...) as a suspension for oral administration, palatibility and compatibility of the formulation when mixed with some types of foods and drinks was investigated. This has been reflected in the SmPC. Adventitious agents Cholic acid is manufactured using bovine and ovine bile as a source material. The safety of the bile with regard to TSE is assured by the Ph Eur Certificate of Suitability. Among excipients used in the drug product only gelatin (component of the capsule shell) and lactose monohydrate (capsule filling

2013 European Medicines Agency - EPARs

14. Effect of oral administration of 'essential' phospholipid, beta-glycerophosphate, and linoleic acid on biliary lipids in patients with cholelithiasis. (Abstract)

Effect of oral administration of 'essential' phospholipid, beta-glycerophosphate, and linoleic acid on biliary lipids in patients with cholelithiasis. 6 patients with radiolucent cholelithiasis underwent randomized successive 3-week trials on each of the following medications: beta-glycerophosphate, linoleic acid, or purified soybean lecithin. Bile-rich duodenal fluid was obtained prior to the study and following each treatment period. Soybean lecithin feeding effected a qualitative change (...) in biliary lecithin with increased fatty acid unsaturation, but no significant improvement in biliary cholesterol saturation or lipid composition changes including a proportionate increase in biliary phospholipids resulted from any treatment program. A 6-month therapeutic trial with soybean lecithin plus cholic acid failed to show a therapeutic response indicative of gallstone dissolution in the 6 patients.

1979 Digestion Controlled trial quality: uncertain

15. Disorders of the Hepatic and Mesenteric Circulation Full Text available with Trip Pro

results have been observed in a phase 3 placebo-controlled trial of lusutrombopag 3 mg once daily ( ). These results led to US Food and Drug Administration approval of avatrombopag and lusutrombopag before elective medical and dental procedures in patients with cirrhosis and platelet count below 50,000/uL. However, TPO-receptor agonists may be associated with an increased risk of thromboembolic events, particularly PVT, in patients with liver disease, and caution is recommended when prescribing (...) heparin cofactor (antithrombin III) in cirrhosis affect the results of the anti-Xa assay, and whether anti-Xa assay or PTT is better to guide heparin therapy is unresolved ( ). Successful use of direct-acting oral anticoagulants (DOACs) such as dabigatran, apixaban, rivaroxaban, and edoxaban has been established in patients with cirrhosis, although these agents are generally avoided in Child-Pugh class B and C patients ( ). The recent approval of andexanet alfa (reversal agent for Xa inhibitors) means

2020 American College of Gastroenterology

16. Allopurinol / lesinurad (Duzallo) - Gout

and pathogenesis 8 2.1.4. Clinical presentation, diagnosis 8 2.1.5. Management 8 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 9 2.2.3. Finished Medicinal Product 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 17 2.2.6. Recommendation for future quality development 17 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 19 2.3.4. Toxicology (...) on the clinical efficacy 72 2.6. Clinical safety 72 2.6.1. Discussion on clinical safety 89 2.6.2. Conclusions on the clinical safety 92 2.7. Risk Management Plan 92 2.8. Pharmacovigilance 94 2.9. Product information 94 2.9.1. User consultation 94 Assessment report EMA/474026/2018 Page 3/100 2.9.2. Additional monitoring 94 3. Benefit-Risk Balance 94 3.1. Therapeutic Context 94 3.1.1. Disease or condition 94 3.1.2. Available therapies and unmet medical need 95 3.1.3. Main clinical studies 95 3.2. Favourable

2018 European Medicines Agency - EPARs

17. Plitidepsin (Aplidin) - Multiple Myeloma

Electrocardiogram ECOG Eastern Cooperative Oncology Group eEF1A2 EFS Eukaryotic Elongation Factor 1A2 Event free survival EMA ER ERK European Medicines Agency Endoplasmic Reticulum extracellular signal–regulated kinases ESMO European Society of Medical Oncology EU European Union F Female FDA Food and Drug Administration (USA) GC Gas chromatography GCP GFR GLP Good Clinical Practice Glomerular filtration rate Good Laboratory Practice HDAC Histone Deacetylase Inhibitor HDPE High density polyethylene HPLC High (...) + 1 ampoule Assessment report EMA/249101/2018 Page 3/156 Table of contents 1. Background information on the procedure 11 1.1. Submission of the dossier 11 1.2. Steps taken for the assessment of the product 12 1.3. Steps taken for the re-examination procedure 13 2. Scientific discussion 13 2.1. Problem statement 13 2.2. Quality aspects 17 2.2.1. Introduction 17 2.2.2. Active Substance 17 2.2.3. Finished Medicinal Product 19 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 24

2018 European Medicines Agency - EPARs

18. Letermovir (Prevymis) - to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant

at the proposed storage conditions. Assessment report EMA/CHMP/490007/2017 Page 12/124 2.2.3. Finished Medicinal Product A. Film-coated Tablets A. Film-coated Tablets Description of the product and Pharmaceutical development Letermovir tablets are formulated as an immediate-release, film-coated tablet for oral administration. The two strengths, 240 mg and 480 mg, are weight multiples of a common granulate. The tablets are packaged in Polyamide/Aluminium/PVC – Aluminium blisters. All excipients are well known (...) and finished product specifications, including blend uniformity, tablet content uniformity, and dissolution performance. Pharmaceutical development of the finished product contains QbD elements. The quality target product profile (QTPP) was defined as an oral immediate release solid dosage form containing 240 mg or 480 mg of letermovir, providing adequate bioavailability to maintain desired plasma levels and consistency in oral absorption (e.g. lack of food effect), all impurities controlled in line

2018 European Medicines Agency - EPARs

19. Rucaparib camsylate - Ovarian Neoplasms

acid DSB double-strand breaks DSC differential scanning calorimetry DVS dynamic vapour sorption EC European Commission ECG(s) electrocardiogram(s) ECOG Eastern Cooperative Oncology Group EMA European Medicines Agency EOC epithelial ovarian cancer ESMO European Society for Medical Oncology EU European Union EU-RMP European Union Risk Management Plan FDA Food and Drug Administration FeSSIF Fed state simulated intestinal fluid Assessment report EMA/CHMP/238139/2018 Page 5/167 FFPE formalin-fixed (...) for Pharmaceuticals for Human Use INN International Nonproprietary Name IPC in-process control IR infrared IRR independent radiological review IV intravenous KF Karl Fischer titration LDPE low density polyethylene LPI last patient in MAA Marketing Authorization Application MAH marketing authorization holder MATE multidrug and toxin extrusion transporter MHRA Medicines and Healthcare products Regulatory Agency MDR1 multidrug resistance protein 1 MDS myelodysplastic syndrome MedDRA Medical Dictionary for Regulatory

2018 European Medicines Agency - EPARs

20. Dolutegravir sodium rilpivirine hydrochloride (Juluca) - HIV Infections

concentration prior to the beginning of a dosing C 24h Plasma concentration after 24 hours CAR Current antiretroviral regimen cART Combination antiretroviral therapy CFU Colony forming units CHMP Committee for Medicinal Products for Human use CI Confidence interval CL Systemic clearance of parent drug CL/F Apparent clearance following oral dosing CL/F/kg Apparent oral clearance adjusted for body weight C max Maximum concentration CMH Cochran-Mantel Haenszel C min Minimum observed concentration CPP (...) , less than 4% in rat and 4 - 6% in monkey. In bile duct cannulated animals, biliary excretion accounted for approximately 2.5% of dose in mouse, 7% of the dose in rat and 12% of dose in monkey. Assessment report EMA/243517/2018 Page 23/109 The predominant route of elimination of rilpivirine drug-related material in all species following oral administration was via faeces (>85%), with a small contribution eliminated in urine ( 0.01 threshold YES Refined PEC accepted for Phase II Other concerns (e.g

2018 European Medicines Agency - EPARs

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