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Post by jeremg on Nov 19, 2015 20:39:20 GMT -5
www.ema.europa.eu/docs/en_GB/document_library/Minutes/2015/03/WC500183844.pdffeast on the above to keep the forum bz.. cant even decipher PKWP position paper on specific questions: 1. Evaluation of orally inhaled medicinal products: For adoption 2. Clarifications on the “Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function” guideline: For adoption So after reading through this I don't think it gives us any further clues as to whether the "insulin human" in question is Afrezza. What you referenced is listed under "Any Other Business" and it seems the action taken for this item is "The CHMP adopted the PKWP position paper." meaning they are adopting a position of the PKWP for future drug assessments. If this does have something to do with Afrezza than the latest "insulin human" which is about to face judgement cannot be Afrezza. If it turns out not to be Afrezza than this newest item coming up for discussion in Jan. may be some intial step in evaluating Technosphere as an entity. I may be completely off in what I understand this jargon as. |
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Post by jeremg on Nov 19, 2015 20:46:45 GMT -5
PKEP = Pharmokinetics Working Party www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002963.pdf21. Evaluation of orally inhaled medicinal products 1. The extent to which plasma levels reflect bio-availability in the lung PKWP Response: In the EU, PK bioequivalence studies are considered an acceptable methodology to compare the lung deposition of two inhalation products containing the same active substance. In cases where the oral bioavailability of swallowed drug is negligible, or in case it is made negligible by active charcoal blockade, the plasma concentration time curve reflects both the extent of and the pattern of deposition within the lungs. To conclude equivalent efficacy, both the amount of drug reaching the lungs and the deposition pattern of drug particles within the lung needs to be equivalent.The area under the plasma concentration-time curve (or AUC) reflects the amount of drug that has reached the lungs. As the rate of absorption from the inhaled particles is different at different areas of the lung, the deposition pattern within the lung is mirrored by the shape of the plasma concentration- time curve during the absorption phase, i.e.Cmax and tmax. In the case where intestinal absorption is not prevented, i.e. in a study without charcoal blockade, and thus absorption is the sum of the absorption via the lungs and intestinal absorption, as for other modes of administration, equivalent systemic safety can be concluded if two products give rise to equivalent systemic exposure (AUC and Cmax). Pharmacokinetic endpoints may be more discriminative than PD or clinical endpoints, in particular the efficacy endpoints available for inhaled corticosteroids. Use of active charcoal and truncated AUCs For some inhaled medicinal products, the contribution of intestinal absorption to systemic exposure is negligible (<5%) and a single dose PK study without charcoal can be used for both efficacy and safety comparisons. Reasons for the negligible contribution include poor intestinal absorption (e.g., chromoglycate, nedocromil), or an extensive first-pass metabolism (e.g., beclomethasone, fluticasone, mometasone, ciclesonide). For drugs with significant oral bioavailability (e.g., budesonide, formoterol, salmeterol), a PK study with active charcoal is necessary to assess efficacy, and a study without charcoal is used to assess safety. The charcoal blockade needs to be validated to demonstrate that oral contribution to total bioavailability is negligible. In case the absorption of the drug in the lung is very quick (e.g., tmax ≤ 5 min) and absorption occurs before the contribution of gastrointestinal absorption is significant (e.g., salbutamol/albuterol, salmeterol), AUC0-30 min might be acceptable as a surrogate for efficacy and AUC0-t for safety. Thus, in this case, one study without active charcoal blockade is sufficient. To be noted, most respiratory medicinal products are now being approved in the EU based on PK studies (e.g., nasal sprays of mometasone in suspension; pMDI in suspension of salbutamol, salmeterol, fluticasone and salmeterol/fluticasone; and DPI of salmeterol/fluticasone). |
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Post by kimi on Nov 20, 2015 7:11:46 GMT -5
The CHMP adopted a negative opinion for Solumarv (insulin human) which was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels. Solumarv was developed as a biosimilar medicine. For more information, please see the questions-and-answers document in the grid below.
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Post by bioexec25 on Nov 20, 2015 7:38:54 GMT -5
The CHMP adopted a negative opinion for Solumarv (insulin human) which was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels. Solumarv was developed as a biosimilar medicine. For more information, please see the questions-and-answers document in the grid below. You talking about the Nov 2012 report Kimi? |
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Post by johnhindepost on Nov 20, 2015 7:59:45 GMT -5
Negative opinion on new medicine The CHMP adopted a negative opinion for Solumarv (insulin human) which was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels. Solumarv was developed as a biosimilar medicine. For more information, please see the questions-and-answers document in the grid below. -------------------------------------------------------------------------------------------------------------------------------------------------- Negative recommendation on new medicine Name of medicine Solumarv International non-proprietary name (INN) insulin human Marketing-authorisation applicant Marvel Life Sciences Ltd Therapeutic indication Treatment of diabetes More information Questions and answers on Solumarv www.google.ie/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=SolumarvI think we should let Marvel Science LTD and its biosimiliar human Insulin attempts go gently into the night. Anyway, nothing to do with an Inhaled Insulin. |
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Post by trenddiver on Nov 20, 2015 8:06:08 GMT -5
Negative opinion on new medicine The CHMP adopted a negative opinion for Solumarv (insulin human) which was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels. Solumarv was developed as a biosimilar medicine. For more information, please see the questions-and-answers document in the grid below. -------------------------------------------------------------------------------------------------------------------------------------------------- Negative recommendation on new medicine Name of medicine Solumarv International non-proprietary name (INN) insulin human Marketing-authorisation applicant Marvel Life Sciences Ltd Therapeutic indication Treatment of diabetes More information Questions and answers on Solumarv www.google.ie/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=SolumarvI think we should let Marvel Science LTD and its biosimiliar human Insulin attempts go gently into the night. Its amazing how much time and energy is wasted on this board speculating, analyzing, dissecting, writing about all this nonsense. Surely you folks have better things to do. Trend |
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Post by derek2 on Nov 20, 2015 8:30:20 GMT -5
Negative opinion on new medicine The CHMP adopted a negative opinion for Solumarv (insulin human) which was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels. Solumarv was developed as a biosimilar medicine. For more information, please see the questions-and-answers document in the grid below. -------------------------------------------------------------------------------------------------------------------------------------------------- Negative recommendation on new medicine Name of medicine Solumarv International non-proprietary name (INN) insulin human Marketing-authorisation applicant Marvel Life Sciences Ltd Therapeutic indication Treatment of diabetes More information Questions and answers on Solumarv www.google.ie/webhp?sourceid=chrome-instant&ion=1&espv=2&ie=UTF-8#q=SolumarvI think we should let Marvel Science LTD and its biosimiliar human Insulin attempts go gently into the night. Its amazing how much time and energy is wasted on this board speculating, analyzing, dissecting, writing about all this nonsense. Surely you folks have better things to do. Trend I take great offence. I have _nothing_ better to do!  Oh, and also... Welcome back, Al! |
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