Azịza ngwa ngwa
Kọmiti Ndụmọdụ Mgbakọ Ahịa nke Julaị 2026 votu na peptides asaa na-ele anya na-ekpebisi ike na akụkọ akụkọ na ọ bụghị mkpebi siri ike na iwu. Ndị ọrụ FDA nke onwe…
Kedu ihe kọmitii ndụmọdụ FDA mere votu na ya, na votu na-agbanwe ihe ọ bụla ma?
Eptides N'ogbe Ezigbo Peptide Kọmiti ahụ tụrụ aro isii n'ime peptides asaa ahọpụtara maka Ndepụta nke 503A, na votu na-agbanwe ọ dịghị iwu ọnọdụ n'onwe ya. Isii bụ BPC-157, KPV, TB-500, c-OKWU, Semax na Epitalon; emideltide, a na-akpọkwa DSIP, akwadoghị (kọmitii nke July 2026 ndekọ nzukọ). Nzukọ ahụ kewara n'ime ụbọchị abụọ, na ihe anọ nụrụ na 23 July na atọ na 24 Julaị, ewe kewaa votu ọ bụla (nyocha ụzọ §503A).
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PCAC votu ogologo site na peptide. data mmanya agbakọtara: BPC-157: Maka 8, megide 6, Zere 1; KPV: Maka 8, megide 6, Zere 1; TB-500: Maka 8, megide 6, Zere 1; c-OKWU: Maka 7, megide 5, Zere 2; egela ntị: Maka 8, megide 5, Zere 1; Epitalon: Maka 7, megide 4, Zere 1; Emideltide: Maka 6, megide 7, Akwụsị 1.Isi iyi: Bass Berry & Sims, njikere ndị ahịa na votu PCAC 2026-07-31.</desc> <ederede x ="280.0" y="29" ederede-arịlịka ="etiti" font-size ="18" font-arọ="800" juru ="Agba ugbu a">PCAC votu ogologo site na peptide</ederede> <ahịrị x1="72" y1="277.0" x2="492" y2="277.0" ọrịa strok ="Agba ugbu a" opacity="0.08" /> <ahịrị x1="72" y1="230.8" x2="492" y2="230.8" ọrịa strok ="Agba ugbu a" opacity="0.08" /> <ahịrị x1="72" y1="184.5" x2="492" y2="184.5" ọrịa strok ="Agba ugbu a" opacity="0.08" /> <ahịrị x1="72" y1="138.2" x2="492" y2="138.2" ọrịa strok ="Agba ugbu a" opacity="0.08" /> <ahịrị x1="72" y1="92.0" x2="492" y2="92.0" ọrịa strok ="Agba ugbu a" opacity="0.08" /> <ederede x ="66" y="281.0" ederede-arịlịka ="ngwucha" font-size ="10" juru ="Agba ugbu a" opacity="0.7">0</ederede> <ederede x ="66" y="234.8" ederede-arịlịka ="ngwucha" font-size ="10" juru ="Agba ugbu a" opacity="0.7">2.5</ederede> <ederede x ="66" y="188.5" ederede-arịlịka ="ngwucha" font-size ="10" juru ="Agba ugbu a" opacity="0.7">5</ederede> <ederede x ="66" y="142.2" ederede-arịlịka ="ngwucha" font-size ="10" juru ="Agba ugbu a" opacity="0.7">7.5</ederede> <ederede x ="66" y="96.0" ederede-arịlịka ="ngwucha" font-size ="10" juru ="Agba ugbu a" opacity="0.7">10</ederede> <ziri ezi x="72.0" y="62" obosara ="10" elu ="10" juru ="#f97316" /> <ederede x ="87.0" y="71" font-size ="11" juru ="Agba ugbu a">Maka</ederede> <ziri ezi x="127.6" y="62" obosara ="10" elu ="10" juru ="#38bdf8" /> <ederede x ="142.6" y="71" font-size ="11" juru ="Agba ugbu a">megide</ederede> <ziri ezi x="208.0" y="62" obosara ="10" elu ="10" juru ="#nke 78bfa" /> <ederede x ="223.0" y="71" font-size ="11" juru ="Agba ugbu a">Zere</ederede> <ziri ezi x="79.0" y="129.0" obosara ="13.3" elu ="148.0" juru ="#f97316" /> <ederede x ="85.7" y="125.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">8</ederede> <ziri ezi x="94.3" y="166.0" obosara ="13.3" elu ="111.0" juru ="#38bdf8" /> <ederede x ="101.0" y="162.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">6</ederede> <ziri ezi x="109.7" y="258.5" obosara ="13.3" elu ="18.5" juru ="#nke 78bfa" /> <ederede x ="116.3" y="254.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">1</ederede> <ederede x ="102.0" y="295.0" ederede-arịlịka ="etiti" font-size ="10" juru ="Agba ugbu a" opacity="0.8"><otu x ="102.0" dy="0">BPC-157</tsp></ederede> <ziri ezi x="139.0" y="129.0" obosara ="13.3" elu ="148.0" juru ="#f97316" /> <ederede x ="145.7" y="125.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">8</ederede> <ziri ezi x="154.3" y="166.0" obosara ="13.3" elu ="111.0" juru ="#38bdf8" /> <ederede x ="161.0" y="162.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">6</ederede> <ziri ezi x="169.7" y="258.5" obosara ="13.3" elu ="18.5" juru ="#nke 78bfa" /> <ederede x ="176.3" y="254.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">1</ederede> <ederede x ="162.0" y="295.0" ederede-arịlịka ="etiti" font-size ="10" juru ="Agba ugbu a" opacity="0.8"><otu x ="162.0" dy="0">KPV</tsp></ederede> <ziri ezi x="199.0" y="129.0" obosara ="13.3" elu ="148.0" juru ="#f97316" /> <ederede x ="205.7" y="125.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">8</ederede> <ziri ezi x="214.3" y="166.0" obosara ="13.3" elu ="111.0" juru ="#38bdf8" /> <ederede x ="221.0" y="162.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">6</ederede> <ziri ezi x="229.7" y="258.5" obosara ="13.3" elu ="18.5" juru ="#nke 78bfa" /> <ederede x ="236.3" y="254.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">1</ederede> <ederede x ="222.0" y="295.0" ederede-arịlịka ="etiti" font-size ="10" juru ="Agba ugbu a" opacity="0.8"><otu x ="222.0" dy="0">TB-500</tsp></ederede> <ziri ezi x="259.0" y="147.5" obosara ="13.3" elu ="129.5" juru ="#f97316" /> <ederede x ="265.7" y="143.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">7</ederede> <ziri ezi x="274.3" y="184.5" obosara ="13.3" elu ="92.5" juru ="#38bdf8" /> <ederede x ="281.0" y="180.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">5</ederede> <ziri ezi x="289.7" y="240.0" obosara ="13.3" elu ="37.0" juru ="#nke 78bfa" /> <ederede x ="296.3" y="236.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">2</ederede> <ederede x ="282.0" y="295.0" ederede-arịlịka ="etiti" font-size ="10" juru ="Agba ugbu a" opacity="0.8"><otu x ="282.0" dy="0">c-OKWU</tsp></ederede> <ziri ezi x="319.0" y="129.0" obosara ="13.3" elu ="148.0" juru ="#f97316" /> <ederede x ="325.7" y="125.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">8</ederede> <ziri ezi x="334.3" y="184.5" obosara ="13.3" elu ="92.5" juru ="#38bdf8" /> <ederede x ="341.0" y="180.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">5</ederede> <ziri ezi x="349.7" y="258.5" obosara ="13.3" elu ="18.5" juru ="#nke 78bfa" /> <ederede x ="356.3" y="254.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">1</ederede> <ederede x ="342.0" y="295.0" ederede-arịlịka ="etiti" font-size ="10" juru ="Agba ugbu a" opacity="0.8"><otu x ="342.0" dy="0">egela ntị</tsp></ederede> <ziri ezi x="379.0" y="147.5" obosara ="13.3" elu ="129.5" juru ="#f97316" /> <ederede x ="385.7" y="143.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">7</ederede> <ziri ezi x="394.3" y="203.0" obosara ="13.3" elu ="74.0" juru ="#38bdf8" /> <ederede x ="401.0" y="199.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">4</ederede> <ziri ezi x="409.7" y="258.5" obosara ="13.3" elu ="18.5" juru ="#nke 78bfa" /> <ederede x ="416.3" y="254.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">1</ederede> <ederede x ="402.0" y="295.0" ederede-arịlịka ="etiti" font-size ="10" juru ="Agba ugbu a" opacity="0.8"><otu x ="402.0" dy="0">Epitalon</tsp></ederede> <ziri ezi x="439.0" y="166.0" obosara ="13.3" elu ="111.0" juru ="#f97316" /> <ederede x ="445.7" y="162.0" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">6</ederede> <ziri ezi x="454.3" y="147.5" obosara ="13.3" elu ="129.5" juru ="#38bdf8" /> <ederede x ="461.0" y="143.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">7</ederede> <ziri ezi x="469.7" y="258.5" obosara ="13.3" elu ="18.5" juru ="#nke 78bfa" /> <ederede x ="476.3" y="254.5" ederede-arịlịka ="etiti" font-size ="9" juru ="Agba ugbu a">1</ederede> <ederede x ="462.0" y="295.0" ederede-arịlịka ="etiti" font-size ="10" juru ="Agba ugbu a" opacity="0.8"><otu x ="462.0" dy="0">Emideltide</tsp></ederede> <ederede x ="280.0" y="366" ederede-arịlịka ="etiti" font-size ="10" juru ="anyi(--chaatị-mechiri emechi, Agba ugbu a)">Isi mmalite: Bass Berry & Sims, njikere ndị ahịa na votu PCAC (2026-07-31)</ederede> </svg> </ọgụgụ>
Ogologo ya dị obere ka ọdịdị ha. BPC-157, KPV na TB-500 nke ọ bụla bu 8-6 nwere 1 abhapụ; MOTS-c bu 7–5 nwere 2 abtentions; Semax 8–5 nwere 1 abhapụ; Epitalon 7–4 nwere 1 abhapụ. Emideltide dara na isii maka, asaa megide na otu abception (Tebụl na-atụ vootu). Oke ya sitere na 7–4 ruo 8–6, nke bụ kọmitii kewara otu oche ma ọ bụ abụọ na ihe ọ dị njikere ịkwado.
Ọ nweghị ihe dị na ndepụta a. Ntuli aka bụ ndụmọdụ, Onye ode akwụkwọ HHS ga-akwadorịrị mgbakwunye ọ bụla, na ụlọ ahịa ọgwụ enweghị ike ịgbakọta peptides ndị a ruo mgbe emebere iwu ikpeazụ, ọbụlagodi ebe API ọkwa ọgwụ dị (mkpuchi ahia ahịa ọgwụ nke votu). Emepụtara ndepụta ahụ n'onwe ya site na iwu n'okpuru ngalaba 503A(c), dị ka Ozi nzuko Federal Register na-ewepụta, ya mere nsonye bụ iwu na-eme iwu karịa omume kọmitii. Ịgụ tally dị ka mkpebi bụ ọnọdụ ọdịda mbụ, na ọ bụ njehie ọgụgụ, ọ bụghị usoro iwu.
Gịnị kpatara ndị ọkà mmụta sayensị ndị ọrụ FDA ji emegide peptides isii niile?
Ndụmọdụ ahụ kewara ekewa dabere na mkpesa ndị ọrụ FDA etinyelarị na ndekọ ahụ. Ndị ọrụ FDA megidere mgbakwunye ọ bụla na mgbakwasị ụkwụ atọ: enweghị data nnwale ụlọ ọgwụ siri ike, usoro na-ekwekọghị ekwekọ site na ogbe ruo ogbe, na ihe ize ndụ nke mmeghachi omume mgbochi na-emerụ ahụ (akụkọ sitere na nzukọ ahụ). Abụọ n'ime atọ ndị ahụ bụ nsogbu kemistri. Enweghị nkwekọ nke ogbe bụ nsogbu nrụpụta-njikwa, na immunogenicity na peptide gbara ya gburugburu bụ nnukwu nsogbu adịghị ọcha na mkpokọta, nke kpatara ya Ngwakọta-nchekwa nke FDA ọkọlọtọ GHRP-2, GHRP-6, ipamorelin acetate na kisspeptin-10 maka ihe ize ndụ nke immunogenicity "n'ihi ikike nke nchịkọta na adịghị ọcha metụtara peptide."
Ndekọ njirimara dị gịrịgịrị na nkenke, checkable ụzọ. Achọpụtara peptides niile ma e wezụga TB-500 "anaghị akọwapụta ya nke ọma site na njiri mara anụ ahụ na kemịkal"; Usoro ude na gel nke KPV tụrụ aro enweghị ozi achọrọ iji nyochaa njirimara physicochemical; Epitalon enweghị ọmụmụ ihe na-enyocha ehighị ụra nke ọma site na ụzọ subcutaneous a chọrọ; Nnyocha Semax bụ naanị ụmụ oke, na-enweghị data nwere ike imebi ihe. Ndị nlebanya ahụ kwuru na ihe ize ndụ immunogenicity pụrụ iche maka usoro injectable (Nlebanya nkenke-akwụkwọ).
A na-agbagha njirimara n'onwe ya. Ndị nkọwa FDA kwuru na aha ndị a na-ahụkarị anaghị agbaso mgbakọ USAN ma ọ bụ INN nwere ike ịkọwa ụdị ọrụ dị iche iche, na ntọala efu ahụ, ụdị nnu na ester nke otu ihe ahụ dị iche na physicochemical, toxicological na pharmacokinetic omume, ya mere aha nanị abụghị ihe a pụrụ ịdabere na ya (nyocha ụzọ §503A). Maka BPC-157 kpọmkwem, A na-ere ọtụtụ ihe n'okpuru otu aha a na-ahụkarị nke nwere ụdị ọrụ dị iche iche, yabụ "enwere ike ọ nweghị ihe ndabere a pụrụ ịdabere na ya iji hụ na aha enyere na-egosipụtakarị otu usoro na ụdị kemịkal ahụ" (Tebụl na-atụ vootu).
Ihe mgbochi ndị ahụ bụ kemikal, ọ bụghị akara-kpọmkwem. Mmemme na-aza ha na-eji akwụkwọ zaa ha, na ngalaba isii dị n'okpuru bụ akwụkwọ.
Ịnọ na ndepụta nchịkọta pụtara akwadoro peptide, mma, ma ọ bụ dị irè?
Nlebanya ndepụta nnukwu na-atụle njirimara anụ ahụ na kemịkal, nchekwa, ihe akaebe nke ịdị irè na iji akụkọ ihe mere eme. Ọ bụghị usoro nnabata ọgwụ ọhụrụ, mana ihe akaebe ụlọ ọgwụ nwere ike ịdị oke mkpa na njirisi nchekwa na ịdị irè. Ndepụta anaghị ewepụta nkwado FDA.
Ụzọ ndị iwu kwadoro dị warara karịa isi akụkọ na-atụ aro. Ngwaahịa agbakwunyere chọrọ otu USP ma ọ bụ NF monograph, ma ọ bụ ihe ọgwụ bụ akụkụ nke ọgwụ FDA kwadoro, ma ọ bụ ebe dị na 503A Bulks List (nke Gku Peptide Ozi nzuko Federal Register). Ụkpụrụ ndepụta nnukwu abụghị nnabata ọgwụ: ndepụta na-atụgharị na njirisi anọ, ọ bụghị na ule na-egosi nchekwa na nrụpụta ọrụ (nyocha ụzọ §503A).
Usoro nnweta nke dị nso nwere ike bụrụ ikike mmanye nwa oge, enwere ike ibugharị peptides na ngalaba 1 nke nwa oge nnukwu amụma. Nke ahụ anaghị agbanwe ụkpụrụ, anaghị akwado ngwaahịa ọ bụla, agaghị ekpuchi ngwaahịa nyocha-naanị ngwaahịa, ihe mgbakwunye ma ọ bụ ụlọ ọrụ mbupụ 503B, agaghị ekekọta bọọdụ steeti, enwere ike ịbelata ma ọ bụ wepụ ya na-enweghị ọkwa (nke October 2026 nyocha mmanye). Ndị mmanye akwụsịghị maka ntuli aka ahụ: FDA nyere ndị na-ere peptide n'ịntanetị akwụkwọ ozi ịdọ aka ná ntị ise 24 Ọgọst 2026, ịchọpụta na ntinye naanị nyocha-eji naanị ihe akaebe erughị ihe akaebe nke iji mmadụ eme ihe (nke October 2026 nyocha mmanye).
Ihe njirisi anọ a bụ oghere enwere ike iji maka akwụkwọ peptide CMC ọbụna na mpụga ngwakọta, n'ihi na ha na-ajụ otu ajụjụ ndị nyocha na-ajụ maka dossier ọ bụla. Ihe ha na-emeghị bụ dochie ndekọ nyocha, nke bụ ebe akụkụ anọ na-esote na-anọdụ ala.
Kedu ihe akaebe FDA na-atụ anya maka peptide, na nke usoro agụta?
Opekempe ụzọ abụọ orthogonal na-atụ anya, na nchikota ga-enweghị mgbagha akwado usoro. Ntuziaka synthetic-peptide EMA na-atụ aro ma ọ dịkarịa ala ụzọ njirimara orthogonal abụọ maka nkọwapụta na mwepụta., e si na uka, oge njide ikwu, LC-MS, LC-MS/MS, maapụ peptide, bioactivity, amino acid analysis ma ọ bụ NMR, ya na onye na-arịọ arịrịọ maka igosi nchikota ahọpụtara na-akwado usoro a (EMA synthetic-peptide ntuziaka).
Ụkpụrụ dị n'okpuru bụ okenye ma gbasaa. Nnwale njirimara kwesịrị ịkapụta nke ukwuu yana dabere n'akụkụ pụrụ iche nke nhazi molekụla, na ihe karịrị otu ule, physicochemical, bayoloji ma ọ bụ immunochemical, nwere ike ịdị mkpa; A na-akpọ ihe mejupụtara amino acid dị ka ozi nhazi bara uru maka peptides na obere protein (I Q6B). ICH Q6B na-ewepu peptides sịntetik site na oke ya wee chegharịa na ntuziaka nke ọgwụ., mana mgbagha njirimara ya bụ nke ndị nchịkwa na-etinye.
Edekọbara ụkpụrụ ọdịda ahụ. Achọpụtaghị ụkọ ihe FDA na-ahụkarị na-adabere na otu usoro HPLC na-emekarị na ọnụ ọgụgụ kasị elu nke a na-achọpụta naanị site na oge njigide oge dị ka ọdịda na-emekarị., ma rụtụ aka na UHPLC-HRMS/MS maka njirimara kacha elu yana ịdị ọcha kacha elu (Ndepụta FDA nke ụkọ nkịtị). Otu nkwenye ukwu na-aza ajụjụ dị iche karịa nkọwapụta.
Ndekọ njirimara kacha nta na-ebu ụdị usoro, nke N- na C-terminus dị ka synthesized, saịtị mgbanwe na kemistri, ụdị counterion, nọmba nza, njirimara usoro, kọlụm, gradient na nchọta wavelength, Ụlọ ọrụ ozi Peptide na ụkpụrụ ntụaka ejiri. Ntugharị ahụ dị na ndepụta ahụ n'ihi na otu peptide dị ka ntọala efu yana acetate abụghị otu ọgwụ ahụ., na nzukọ ahụ tụlere ụdị abụọ ahụ maka ihe ọ bụla.
Mgbanwe MOL na-akọwa HPLC na nnwale uka-spectrometric n'etiti ọrụ ya. Ebe HPLC dị ọcha gbakwunyere uka emebibeghị adịghị, n'onwe ya, guzobe njirimara usoro, mgbanwe saịtị akọwapụtara ma ọ bụ ngwugwu njirimara orthogonal. Rịọ ụzọ na ihe akaebe achọrọ maka iji wuo yana ebumnuche a.
Kedu ihe kpatara otu pasent ịdị ọcha HPLC ezughị, na ihe ọzọ a ga-atụ?
Ịdị ọcha, njirimara, ọdịnaya na profaịlụ adịghị ọcha bụ nha anọ, na ọnụ ọgụgụ mpaghara pasentị na-aza naanị akụkụ nke otu. Ịdị ọcha zuru oke siri ike ịchọpụta na nsonaazụ ya dabere na usoro, ya mere a na-eme atụmatụ ịdị ọcha site na nchikota nke usoro kama otu chromatogram (Nkọwa ICH Q6B nke ịdị ọcha). ICH Q6B depụtara ụzọ dị ọcha iche na ụzọ adịghị ọcha, nke mere na otu nọmba enweghị ike ije ozi dị ka nkọwapụta.
Ọnụ ụzọ dị iche na usoro, na ibu iwu dị iche na ha. Maka peptides sịntetik, ihe Ph. Euro. monograph izugbe na ihe maka iji ọgwụ eme ihe na-edobe adịghị ọcha metụtara peptide ka a ga-akọ n'elu. 0.1%, chọpụtara n'elu 0.5% ma tozuru oke n'elu 1.0%, na ntuziaka EMA na-emetụta otu ọnụ ụzọ na ngwaahịa emechara (EMA synthetic-peptide ntuziaka). I Q3A(R2) na-esetịpụ ụkpụrụ dị iche iche maka adịghị ọcha nke ọgwụ na oke kwa ụbọchị 2 g / ụbọchị ma ọ bụ obere: akuko 0.05%, njirimara 0.10% ma ọ bụ 1.0 mg / ụbọchị nke ọ bụla dị ala, iru eru 0.15% ma ọ bụ 1.0 mg / ụbọchị (I Q3A(R2) akuko na oke iru eru). Ntuziaka EMA na-ekwu na ewepu peptides sịntetik na ICH Q3A na oke ya anaghị etinye., ya mere ubube abụọ ahụ anaghị agbanwe agbanwe.
Ntuziaka ngwaahịa nke FDA maka semaglutide, edegharịrị na July 2026, na-eji ihe 0.1% na 0.5% kọọ ma chọpụta ọnụọgụgụ mana ọ na-agbakwunye nkọwa nke ikwu: adịghị ọcha ọ bụla nkekọrịta ekwesịghị ịfe ọkwa ọkwa ọgwụ edepụtara edepụtara ma ọ bụ 1.0%, nke ọ bụla ka ukwuu, ọhụrụ adịghị ọcha kwesịrị ibelata n'okpuru 1.0%, yana ngụkọta adịghị arụ ọrụ na-eme ihe na-eme ihe agaghị agafe ngwaahịa ntụaka (nke Julaị 2026 ntuziaka kpọmkwem ngwaahịa). Akara akwụkwọ ahụ akara ọ bụghị maka mmejuputa ya, na ọ bụ ngwaahịa-kpọmkwem, ya mere ọ naghị ewepụta oke peptide izugbe.
Ntuziaka peptide EU na mpempe akwụkwọ US semaglutide akọwapụtara nwere oke dị iche iche. Nyochaa ezigbo ngwaahịa na njirisi adịghị ọcha; oke mkpesa ma ọ bụ iru eru abụghị n'onwe ya oke ntọhapụ, na ntụnyere semaglutide enweghị ike ịkọwa nnabata US nke peptide ọ bụla.
Kedu ka ị ga-esi gosi na mmụgharị ọtụtụ ihe na usoro nkwụsi ike?
A na-egosipụta mmegharigharị site na ndekọ nza ejikọrọ na usoro egosipụtara iji chọpụta mmebi, ọ bụghị site na asambodo atọ na onye ọ bụla na-ekwupụta pasent dị elu. Ntuziaka EMA chọrọ ka a mụọ nkwụsi ike na-egosi njirimara na nguzozi nke usoro a, ma na-emeso nnweta nkwụsi ike n'oge na-egosi ụzọ na mkpebi kacha elu yana ezigbo nguzozi nke oke dị ka ihe dị mkpa. (EMA synthetic-peptide ntuziaka). Ọmụmụ nbibi nke mmanye aghaghị igosi ma mmebi nke peptide na ike nke usoro nyocha iji chọpụta ya..
Peptides na-eme ka ihe a chọrọ ka sie ike. Otu ntuziaka ahụ na-ekwu na peptides na-adịkarị ka ọkụ ọkụ, ya mere ekwesịrị ịchọpụta mmebi na ọnọdụ nchekwa na-ekwesịghị ekwesị, ma ọ depụtara oxidation nke Cys na Met residues, deamidation, hydrolysis na beta-Asp-nwere usoro dị ka ụzọ mmebi iwu iji kparịta (EMA synthetic-peptide ntuziaka). Ekwesịrị inyocha nhazi nke adịghị ọcha dị elu-molecular n'oge nkwụsi ike ebe ọ dị. Ụlọ ọrụ Peptide P
Nkwado nwere ọnụ ụzọ nke ya. Usoro adịghị ọcha nke ọnụọgụ chọrọ nkọwapụta, oke nwere oke dị ala na oke ọnụọgụ, izi ezi na nkenke, yana ụkpụrụ nkwado nke na-ekwupụta ebumnobi ebumnobi ya, njirimara na njirisi ga-adịrịrị tupu ọmụmụ ihe (I Q2(R2) Tebụl 1). Ntuziaka EMA anaghị agbakwunye enweghị nkwado nkwado ọzọ karịa nke maka ihe ndị ọzọ na-arụ ọrụ kemịkal.
Maka mmemme nyocha, Atụmanya nkwụsi ike bụ oge kwesịrị ekwesị kama ịbụ nke ikpeazụ. Achọrọ data nkwụsi ike n'usoro niile iji gosi na ihe ahụ nọ n'ime oke kemịkalụ na nke anụ ahụ anabatara maka oge akwadoro, na ebe akwadoro ule nwa oge, data na-akwado nwere ike kpachi ya (21 CFR 312.23).
Ndekọ nza ejikọrọ dị ka nke a: otutu nọmba, chromatogram nwere njirimara usoro na ọkọlọtọ ntụaka, nsonaazụ mmanye-mmebi nke na-egosi usoro na-edozi ndị na-emebi ihe, na usoro nkwụsi ike na ọnọdụ nchekwa ya na oge oge. Nleba elu bụ ebe ndekọ na-agbajikarị, n'ihi na a ga-atụnyere profaịlụ adịghị ọcha gbanwere na pilot ma ọ bụ batches azụmahịa megide data mbụ yana mmetụta ọ na-enwe na ịdị mma yana na data ụlọ ọgwụ na nke a tụlere. (EMA synthetic-peptide ntuziaka).
Kedu ọgwụ ọgwụ ụlọ ọgwụ na akwụkwọ ụlọ ọgwụ na-achọ peptide tupu mkparịta ụka IND?
Ihe ndekọ ụlọ ọgwụ bụ ọnụ ụzọ kasị sie ike na nke na-edozi usoro iheomume, n'ihi na enwere ike wughachi ngwugwu nyocha ngwa ngwa karịa ka enwere ike ịmepụta data mmadụ. Ndị na-enyocha FDA ahụghị usoro ọ bụla emechara 3 ule na-enweghị usoro n'ofe peptides isii niile akwadoro, ma nyochaa obere ule mmadụ ise maka BPC-157 (akụkọ kọmitii-mejupụtara). Peptide
Ngụkọta per-peptide dị gịrịgịrị karịa ntuli aka na-atụ aro. Obere karịa 36 ndị mmadụ gburugburu 3 ọmụmụ na-akwado BPC-157, nke nwere ihe omumu ihe omumu iri na isii nke ikpere, ihe omumu ogwu ogwu nke onye oria iri na abuo na ihe omumu infusion nke 2, ya na anụmanụ ndị ọzọ na-egosi BPC-157; KPV, MOTS-c na TB-500 nwere enweghị ọmụmụ zuru oke na ụmụ mmadụ site n'ụzọ ọ bụla; Ihe data Semax nwere oke na ọmụmụ ezughị oke emere na mba ofesi ọ bụghị n'okpuru IND; Nnwale ụmụ mmadụ Epitalon na-agba ọsọ na Russia na Ukraine na-abụghị nlekọta FDA ma ọ bụ omume ụlọ ọgwụ kwadoro ICH. (nkọwa docket nke na-agbatị data mmadụ).
Atụmanya ọgwụ ọgwụ bụ kpọmkwem peptide ma ka na-edepụta. Ntuziaka ntuziaka FDA na nkà mmụta ọgwụ ụlọ ọgwụ maka ngwaahịa ọgwụ peptide, ewepụtara Disemba 2023 na akara na ọ bụghị maka mmejuputa iwu, na-agwọ ọrịa imeju, mmekọrịta nke ọgwụ ọjọọ, Ihe ize ndụ ịgbatị QTc na ihe ize ndụ nke immunogenicity dị ka atụmatụ peptide-kpọmkwem (Ntuziaka peptide na-ahụ maka ọgwụ ọgwụ FDA). Nkwupụta ụlọ ọrụ na-ekwu na docket na-arụ ụka na ihe ize ndụ mmekọrịta ọgwụ na ọgwụ pharmacokinetic na peptides dị obere., na peptides anaghị adịkarị CYP-metabolized, na na otu biomarker nwere ike ọ gaghị ezu, na nkwado abụọ ma ọ bụ karịa ka mma nghọta nke nchekwa na nrụpụta ọrụ (nkwupụta nke ụlọ ọrụ na docket). Ndị ahụ bụ ọnọdụ ndị nkwado, ọ bụghị ụlọ ọrụ chọrọ.
Ụzọ usoro dị. Nzukọ tupu IND bụ ụdị nzuko ama ama ụdị B n'okpuru usoro nzukọ nzukọ FDA maka ngwaahịa PDUFA. (Ntuziaka nzukọ ọmụmụ nke PDUFA FDA). Ihe iwu anaghị eme bụ ịtọ ọdịnaya nke peptide akọwapụtara: 21 CFR 312.23 chọrọ oke nnabata na ụzọ nyocha maka njirimara, ike, àgwà na ịdị ọcha, ma kwuo na a naghị atụ anya nkọwa ikpeazụ ruo ọgwụgwụ nke usoro nyocha (21 CFR 312.23). Akụkọ a abụghị ndụmọdụ nchịkwa; mmemme kwesịrị ịkwado ngwugwu nke ya megide nduzi ugbu a yana FDA ozugbo.
Kedu ka ngalaba isii si ejikọta n'ime otu mkpebi njikere?
Ngalaba isii ahụ na-etolite usoro ọnụ ụzọ ámá, na ọnụ ụzọ ámá kachasị ike na-edozi usoro iheomume karịa nkezi. Ọnụ ụzọ ámá nke mbụ bụ njirimara: opekata mpe ụzọ abụọ orthogonal nke nchikota ya na-akwado usoro (EMA synthetic-peptide ntuziaka). Ọnụ ụzọ ámá abụọ bụ ịdị ọcha gbakwunyere nguzozi nke oke, na usoro nkwụsi ike-egosi nke a na-achọpụta n'ezie ngwaahịa mmebi ya. Ọnụ ụzọ ámá atọ bụ profaịlụ adịghị ọcha ewegara n'ọnụ ụzọ ọdabara, ya na ọnụ ọgụgụ kacha elu edoziri ma ọ bụ ọnụ ọgụgụ kacha elu ruru eru.
Jiri usoro nlere anya na ntụnyere ziri ezi wee nyochaa akụkọ ihe mere eme. Q2(R2) na-ekwu maka nkwado usoro nyocha; ọ bụghị n'onwe ya ụkpụrụ nkwado ma ọ bụ ụkpụrụ nza.
Nyochaa ọkwa FDA nke gọọmentị maka nzukọ ndụmọdụ peptide ọ bụla ọzọ yana ebumnuche ya. Window nzụkọ amụma abụghị nyocha emechachara ma ọ bụ ụbọchị amụma ekwere na ya.
Ajụjụ a na-ajụkarị
Emere July 2026 votu tinye peptides ndị a na Ndepụta nnukwu 503A?
Mba. Kọmiti ahụ tụrụ aro isii n'ime asaa, na nkwanye bụ ndụmọdụ. Otu ihe na-erute ndepụta ahụ naanị site na nhazi ọkwa na nkwupụta n'okpuru ngalaba 503A(c), na ruo mgbe a ikpeazụ iwu mbipụta, ịgbakọta peptides ndị a na-anọgide na mpụga ọdụ ụgbọ mmiri 503A (ọkwa nzuko Federal Register).
Bụ a 98% Nsonaazụ ịdị ọcha HPLC zuru oke maka nkọwapụta peptide?
Mba. Ịdị ọcha na-adabere na usoro na atụmatụ site na ngwakọta nke usoro, na ICH Q6B depụtara ụzọ ịdị ọcha iche na ụzọ adịghị ọcha (Nkọwa ICH Q6B nke ịdị ọcha). Nkọwapụta chọkwara njirimara site na opekata mpe ụzọ abụọ orthogonal, profaịlụ adịghị ọcha na ọnụ ụzọ ọdabara, ọdịnaya na ndabere anhydrous na-enweghị mgbochi, na usoro nkwụsi ike-egosi.
Kedu ọnụ ụzọ adịghị ọcha na-emetụta peptide sịntetik?
Ọ dabere na ọchịchị. Ph.D. Euro. Ọnụ ụzọ ekwughachiri na ntuziaka EMA bụ akụkọ dị n'elu 0.1%, mata n'elu 0.5% ma tozuo oke 1.0% (EMA synthetic-peptide ntuziaka). I Q3A(R2) tent 0.05%, 0.10% na 0.15% na kacha kwa ụbọchị dose nke 2 g / ụbọchị ma ọ bụ obere, na ntuziaka EMA kwuru na oke ndị ahụ anaghị emetụta peptides sịntetik (I Q3A(R2) akuko na oke iru eru).
Kedu data mmadụ dị maka peptides isii a tụrụ aro?
Ndị na-enyocha FDA ahụghị usoro ọ bụla emechara 3 randomized ule gafee isii (akụkọ kọmitii-mejupụtara). Nkọwa docket dị obere karịa 36 isiokwu gafee 3 BPC-157 ọmụmụ, enweghị ọmụmụ nchịkwa mmadụ maka KPV, MOTS-c ma ọ bụ TB-500, na ọmụmụ mba ofesi maka Semax na Epitalon emere na mpụga IND ma ọ bụ ICH-kwekọrọ ezigbo omume ụlọ ọgwụ. (nkọwa docket nke na-agbatị data mmadụ).
Mmechi
Ntuli aka bụ nke kewara ekewa na njirisi iwu anọ, na ihe mgbochi n'azụ nkewa bụ chemical na akwụkwọ: njirimara nke aha na-agaghị ekwe nkwa, profaịlụ adịghị ọcha nke otu chromatogram enweghị ike iwulite, ogbe ekwekọghị ekwekọ, na ndekọ ụlọ ọgwụ na n'ọtụtụ ọnọdụ adịghị adị. Nyocha ngalaba isii na-atụgharị ihe mgbochi ndị ahụ ka ọ bụrụ ndepụta ọrụ, na ọnụ ụzọ ámá kasị ike, na-abụkarị akwụkwọ ụlọ ọgwụ, na-esetịpụ usoro iheomume.
Nzọụkwụ ọzọ bụ ịgba ọsọ ọnụ ụzọ ámá isii megide otu usoro ma dekọọ ebe ihe akaebe ahụ kwụsịrị. Mmemme nwere ike ịkọwa ụzọ njirimara ya, ọnụ ụzọ adịghị ọcha ya na ibu iwu ha, nsonaazụ mmanye-emebi, akụkọ ihe mere eme ya na ọnọdụ data mmadụ nwere ngwugwu ndị ọrụ FDA kwuru na ọ na-efu, ma o nwere ya tupu nhọpụta nke abụọ erute na kọmitii.
Nkpughe nke onye mbipụta: MOL Mgbanwe na-enye ọrụ peptide ma nwee mmasị azụmahịa na isiokwu a. Ogo ọrụ na nkwupụta ikike bụ nkwupụta ndị na-ebubata ya; nnweta na ịrụ ọrụ maka otu ihe owuwu chọrọ ihe akaebe akọwapụtara nke ọma.
