User talk:Gigantev

Copyright problem on The International Pharmacopoeia
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Copyright problem on The International Pharmacopoeia reply
Dear Diana, thank you for your message. We are very pleased about the Wikipedia staff oversight on the content published on this platform. I work for The World Health Organization in the Medicine Quality Assurance Group responible also for mantaining the The International Pharmacopoeia. The [|Wikipedia page on the International Pharmacopoeia] was outdated and I enriched it with new references and a more comprehensive content. My team is responsible for the content provided on the WHO webpages http://www.who.int/medicines/publications/pharmacopoeia/en/ and I can anticipate that a new update will be required in the next few months also on this page https://en.wikipedia.org/wiki/The_International_Pharmacopoeia. Please let me know if you need a written confirmation by my supervisor on this activity. Kind regards,

Valeria Gigante Technical Officer HQ/TSN Technologies Standards and Norms World Health Organization Geneva, Switzerland Web: www.who.int Follow WHO on Facebook, Twitter, YouTube, Instagram Gigantev (talk) 08:29, 14 May 2018 (UTC)

Copyright problem on Bioequivalence reply
Dear Diaana, I noticed that you remove my edit on the Bioequivalence guideline too. It is quite important that the The World Health Organization position is reflected and we have to use official statments and reference. Could you please revert my edit? Please let me know if you need a written confirmation by my supervisor on this activity. Kind regards,

Valeria Gigante Technical Officer HQ/TSN Technologies Standards and Norms World Health Organization Geneva, Switzerland Web: www.who.int Follow WHO on Facebook, Twitter, YouTube, Instagram

Gigantev (talk) 15:08, 14 May 2018 (UTC)

Biowaivers
The World_Health_Organization (WHO) defines biowaivers the regulatory pharmaceutical procedures in which exemption from in vivo bioavailability studies to demonstrate bioequivalence between a multisource (generic) medicinal products and its comparator is granted. The scope is to predict in vivo performance of multisource medicinal products using in vitro dissolution studies and relying on the knowledge of the product physical and biopharmaceutical characteristics.

The WHO foresees the exemption from in vivo [|bioequivalence] studies for multisource (generic) products formulated as immediate released solid oral pharmaceutical form containing active pharmaceutical ingredients (API) Class 1 and Class 3 according to the Biopharmaceutical Classification System (BCS) framework. According to the WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (WHO Technical Report Series, No. 1003, 2017, Annex 6),"a BCS-based biowaiver approach considers the following aspects:
 * 1) 	the solubility and intestinal permeability of the API;
 * 2) 	the similarity of the dissolution profiles of the multisource and comparator products in pH 1.2, 4.5 and 6.8 media;
 * 3) 	the excipients used in the formulation;
 * 4)       the risks of an incorrect biowaiver decision in terms of the therapeutic index of and clinical indications for the API".

The WHO defines API as "highly soluble when the highest single therapeutic dose reccomended by the labelling of the comparator product, is soluble in 250 mL or less of aqueous media over the pH range of 1.2–6.8. The WHO considers API highly permeable when the extent of absorption in humans is 85% or more based on a mass balance study or in comparison with an i.v. dose of the comparator product".

Only API belonging to Class 1 and Class 3 are eligible for biowaiver, therefore, a correct BCS-based classification is deemed crucial when considering such regulatory pathway. On the basis of their dissolution properties, finished pharmaceutic products (FPP) can be categorized as having “very rapid”, “rapid”, or “not rapid” dissolution characteristics. According to the WHO guidances, "dosage forms of APIs that are highly soluble, highly permeable (BCS Class 1) with acceptable excipient content and favorable benefit-risk analysis and which are rapidly dissolving, are eligible for a BCS-based biowaiver provided:

i.	the dosage form is rapidly dissolving and the dissolution profile of the multisource product is similar to that of the comparator product in aqueous buffers at pH 1.2, pH 4.5 and pH 6.8 using the paddle method at 75 rpm or the basket method at 100 rpm and meets the criteria of dissolution profile similarity, f₂ ≥ 50 (or equivalent statistical criterion); ii. if both the comparator and the multisource dosage forms are very rapidly dissolving the two products are deemed equivalent and a profile comparison is not necessary.

Dosage forms of APIs that are highly soluble and have low permeability (BCS Class 3) are eligible for biowaivers provided all the criteria listed above (1-4) are met and the benefit—risk is additionally addressed in terms of extent, site and mechanism of absorption. Only when there is an acceptable benefit- risk balance in terms of public health and risk to the individual patient should bioequivalence testing be waived and the in  vitro methods applied as a test of product equivalence".

--Gigantev (talk) 15:55, 14 May 2018 (UTC)

AfC notification: Draft:Biowaivers has a new comment
 I've left a comment on your Articles for Creation submission, which can be viewed at Draft:Biowaivers. Thanks! Nosebagbear (talk) 14:01, 24 June 2018 (UTC)

Your submission at Articles for creation: Biowaivers (August 27)
 Your recent article submission to Articles for Creation has been reviewed! Unfortunately, it has not been accepted because it included copyrighted content, which is not permitted on Wikipedia.

You are welcome to write an article on the subject, but please do not use copyrighted work.


 * Draft:Biowaivers may be deleted at any time unless the copied text is removed. Copyrighted work cannot be allowed to remain on Wikipedia.
 * If you need any assistance, you can ask for help at the [//en.wikipedia.org/w/index.php?title=Wikipedia:WikiProject_Articles_for_creation/Help_desk&action=edit&section=new&nosummary=1&preload=Template:Afc_decline/HD_preload&preloadparams%5B%5D=User_talk:Gigantev Articles for creation help desk] or on the [//en.wikipedia.org/w/index.php?title=User_talk:Abelmoschus_Esculentus&action=edit&section=new&nosummary=1&preload=Template:Afc_decline/HD_preload&preloadparams%5B%5D=User_talk:Gigantev reviewer's talk page].
 * You can also use Wikipedia's real-time chat help from experienced editors.

~AE ( talk  •  contributions ) 05:43, 27 August 2018 (UTC)

Dear Abelmoschus Esculentus, thank you for taking the time to review my article on Biowaiver.

We are very pleased about the Wikipedia oversight on the content published on this platform. I work for The World Health Organization (WHO) in the Medicine Quality Assurance Group responible for the development of WHO Guidances on Bioequivalence and Bioewaiver. My team is responsible for the content provided on the WHO webpages: http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/ Please let me know if you need a written confirmation by my supervisor on this activity as we own the content that was proposed also here. Kind regards,

Valeria Gigante Technical Officer HQ/TSN Technologies Standards and Norms World Health Organization Geneva, Switzerland Web: www.who.int Follow WHO on Facebook, Twitter, YouTube, Instagram Gigantev (talk) 13:22, 27 August 2018 (UTC)


 * Good day,
 * The issue you are running into is that you are trying to copy content already published on the WHO's website, which sports a prominent copyright at the bottom without any clear indication of licensing rights.
 * While I understand that it is in WHO's best interest to ensure education on the variety of issues it covers is accurate on Wikipedia, we cannot accept copyrighted content published elsewhere without explicit permission. To do so, an authorized representative from WHO should follow the steps outlined here, or relevant portions of the WHO website would need to be modified to show a Creative Commons Attribution Sharealike license 3.0 on pages published by your team.
 * Please also note that by granting permission to use your text, the grant is extended to all Wikipedia users and downstream third-party re-users to share and modify your content, even for commercial use, under the sole conditions that they credit you and carry the same license forward.
 * Kindly, MLauba (Talk) 09:32, 1 September 2018 (UTC)

Your draft article, Draft:Biowaivers


Hello, Gigantev. It has been over six months since you last edited the Articles for Creation submission or Draft page you started, "Biowaivers".

In accordance with our policy that Wikipedia is not for the indefinite hosting of material deemed unsuitable for the encyclopedia mainspace, the draft has been nominated for deletion. If you plan on working on it further, or editing it to address the issues raised if it was declined, simply and remove the, , or  code.

If your submission has already been deleted by the time you get there, and you wish to retrieve it, you can request its undeletion by following the instructions at this link. An administrator will, in most cases, restore the submission so you can continue to work on it.

Thanks for your submission to Wikipedia, and happy editing. Dolotta (talk) 16:16, 13 March 2019 (UTC)