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scorp2011 ☆ India, 2011-11-25 09:52 (5326 d 15:43 ago) Posting: # 7718 Views: 6,231 |
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Dear HS, Hats off to this wonderful site designed and maintained by you. One can get precise and detailed information. Regarding the question, I would like to know how to perform and documents BE studies for the generic equivalents of Opthalmic and Otic suspensions. Further, If someone have the literature and guidance available with them, please provide the link for the same. Thanks in aniticipation. Regards Sonu |
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ElMaestro ★★★ Denmark, 2011-11-25 11:40 (5326 d 13:56 ago) @ scorp2011 Posting: # 7719 Views: 5,333 |
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Hi Sonu, ❝ Regarding the question, I would like to know how to perform and documents BE studies for the generic equivalents of Opthalmic and Otic suspensions. Further, If someone have the literature and guidance available with them, please provide the link for the same. You do not write which market you are targeting. If you are going for EU/US, there is a risk that the necessary pivotal study is based on a pharmacodynamic endpoint rather than a pharmacokinetic. Things bare heading in that direction and regulators might play the assay sensitivity card, which can complicate the design a lot. For EU, a PD trial would most likely imply submission under article 10.3 so it isn't a generic in the classical sense. A true generic should be possible in the US due to their definition of BE. Best regards, EM. — Pass or fail! ElMaestro |
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scorp2011 ☆ India, 2011-11-25 11:58 (5326 d 13:37 ago) @ ElMaestro Posting: # 7720 Views: 5,600 |
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Hi EM, I intend to go for US FDA submission. As per the individual product bioequivalence recommendations for Dexamethasone; Tobramycin (Suspension/Ophthalmic), the following studies are recommended. Type of study: Bioequivalence study with pharmacokinetic (PK) endpoints Design: Single-dose, parallel design, in-vivo in aqueous humor Strength: 0.1%/0.3% Subjects: Patients undergoing indicated cataract surgery The study is conducted in patients undergoing indicated cataract surgery. A single dose of the test or reference product is instilled into the inferior cul de sac of the eye prior to cataract extraction. A single sample of aqueous humor is collected from each eye (two samples per patient), where one eye is treated with test product and the other eye with reference product, at one assigned time point. The concentration of dexamethasone from both aqueous humor samples is included in the bioequivalence analysis. The number of subjects to be enrolled should be determined from the results of a pilot study. In order to demonstrate bioequivalence, an adequate estimation of the rate (Cmax) and extent (AUC) of dexamethasone absorption is needed. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] Edit: FDA’s Draft Guidance linked. [Helmut] |
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ElMaestro ★★★ Denmark, 2011-11-25 13:27 (5326 d 12:08 ago) @ scorp2011 Posting: # 7721 Views: 5,399 |
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Hello Sonu, ❝ As per the individual product bioequivalence recommendations for Dexamethasone; Tobramycin (Suspension/Ophthalmic), the following studies are recommended. ❝ ❝ Type of study: Bioequivalence study with pharmacokinetic (PK) endpoints ❝ Design: Single-dose, parallel design, in-vivo in aqueous humor ❝ Strength: 0.1%/0.3% ❝ Subjects: Patients undergoing indicated cataract surgery OK I thought this was a question about a suspension product for which no specific guidance existed. Since the design is given, what is your question? Best regards, EM. |
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scorp2011 ☆ India, 2011-12-07 08:27 (5314 d 17:08 ago) (edited on 2011-12-07 10:23) @ ElMaestro Posting: # 7762 Views: 5,226 |
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Ing. Helmut Schütz