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Norah ★ Tunisia, 2018-02-20 10:14 (2426 d 20:15 ago) Posting: # 18437 Views: 7,445 |
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Hello, I need your advice please for diclofenac SR 75 mg: should study be conducted in fasting or fed state? thanks a lot * Emea guidelines should be followed for me |
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Helmut ★★★   Vienna, Austria, 2018-02-20 13:45 (2426 d 16:44 ago) @ Norah Posting: # 18438 Views: 6,539 |
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Hi Norah, see this post #3. The collection of Guidelines / Guidances is linked in the menu of the Forum. Details are given in Appendix IV of the EMA’s GL. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Norah ★ Tunisia, 2018-03-09 17:45 (2409 d 12:44 ago) @ Helmut Posting: # 18514 Views: 6,035 |
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Thank you Helmut :) |
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xtianbadillo ☆ Mexico, 2018-03-09 20:31 (2409 d 09:58 ago) @ Norah Posting: # 18518 Views: 6,174 |
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❝ Hello, I need your advice please for diclofenac SR 75 mg: ❝ should study be conducted in fasting or fed state? https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm188529.pdf Active ingredient: Diclofenac Sodium Form/Route: Extended Release Tablets/Oral Recommended studies: 2 studies 1. Type of study: Fasting Design: Single-dose, two-way, crossover in-vivo Strength: 100 mg Subjects: Healthy males and nonpregnant females, general population. Additional Comments: ______________________________________________________________________________ 2. Type of study: Fed Design: Single-dose, two-way, crossover in-vivo Strength: 100 mg Subjects: Healthy males and nonpregnant females, general population. Additional comments: _______________________________ |
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Norah ★ Tunisia, 2018-03-14 12:55 (2404 d 17:33 ago) @ xtianbadillo Posting: # 18535 Views: 5,940 |
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Dear xtianbadillo ❝ Active ingredient: Diclofenac Sodium ❝ Form/Route: Extended Release Tablets/Oral ❝ Recommended studies: 2 studies : does it mean that both should be perofrmed?? thanks ____ |
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xtianbadillo ☆ Mexico, 2018-03-16 16:26 (2402 d 14:03 ago) @ Norah Posting: # 18562 Views: 5,907 |
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❝ ❝ Recommended studies: 2 studies : does it mean that both should be perofrmed?? Yes, you have to perform both studies. There are some recommendations. 1) Two cross-over, One study should be conducted under fasting conditions and the other after-meal intake at a specific time before the administration of the treatment. 2) A study cross-over, with four periods, with four sequences for four treatments. Both the test medication and the reference medicine should be evaluated under fasting conditions and after food intake at a specific time before the administration of the treatment. |
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Norah ★ Tunisia, 2018-04-02 14:22 (2385 d 17:07 ago) @ xtianbadillo Posting: # 18629 Views: 5,596 |
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thanks again xtianbadillo!! |
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nobody nothing 2018-04-02 16:29 (2385 d 14:59 ago) @ Norah Posting: # 18631 Views: 5,633 |
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Your first post: ❝ * Emea guidelines should be followed for me ...and then somebody posts the FDA guidance and you are happy. Did I miss something? — Kindest regards, nobody |
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Norah ★ Tunisia, 2018-04-02 17:05 (2385 d 14:24 ago) @ nobody Posting: # 18632 Views: 5,593 |
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Hello No Body It is not what I need , but I have to thank him for his reply !! |
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balakotu ★ India, 2018-04-13 10:22 (2374 d 21:07 ago) @ Norah Posting: # 18678 Views: 5,307 |
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❝ Hello, I need your advice please for diclofenac SR 75 mg: ❝ should study be conducted in fasting or fed state? ❝ thanks a lot ❝ * Emea guidelines should be followed for me Dear Norah, "Diclofenac sodium 75 mg SR tablets" is modified release formulation. Please be noted that, as per EMEA, we need to consider fasting, fed and multiple dose studies for Modified release (ER, SR, MR) formulations. Please find the below statement from EMA guidelines on modified release formulations. Page number 18 & 19. {Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1)} 6.1.1. Studies generally required to demonstrate bioequivalence: a single-dose fasting study comparing test and reference drug product. a single-dose fed study using a high-fat meal comparing test and reference drug product. a multiple-dose study comparing test and reference drug product. We can skip the multiple dose study by showing a low extent of accumulation for the formulation. We need to show the mean AUC(0-tau) after the first dose covers more than 90% of mean AUC(0-inf) for both test and reference in fed study. (fed condition is the SmPC recommendation). The dose is One tablet once or twice daily. So we need to consider 12 hours as the tau (dosing interval). If you show the mean AUC0-12 is more than 90% of the mean AUC0-inf for both test and reference in fed study, you can skip multiple dose study. Ref: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/11/WC500177884.pdf https://www.medicines.org.uk/emc/product/2661/smpc |
Ing. Helmut Schütz