Ha e le hantle komiti ea boeletsi ea FDA e ile ea khetha eng, mme na voutu e fetola eng kapa eng?
Eptides Wholesale Peptide ea 'nete Komiti e khothalelitse li-peptide tse tšeletseng ho tse supileng tse khethiloeng bakeng sa Lenane la Bongata la Karolo ea 503A, 'me voutu ha e fetole boemo ba molao ka bo eona. Tse tšeletseng e ne e le BPC-157, KPV, TB-500, c-MANTSOE, Semax le Epitalon; emideltide, hape e bitsoa DSIP, ha ea khothaletsoa (komiti ea July 2026 rekoto ea kopano). Kopano e ile ea arohana matsatsi a mabeli, ka dintho tse nne tse utluwang 23 Phupu le tse tharo ho ea pele 24 Phupu, mme voutu e nngwe le e nngwe ya arolwa (tlhahlobo ea tsela ea §503A).
<sehlopha sa lipalo="chate ea blog" mokhoa="boholo ba bophara:640px;moeling:1.5rem auto;boholo ba fonte:12px;bophahamo ba mola:1.3;mmala:lefa"> <svg viewBox="0 0 560 380" mokhoa="boholo ba bophara: 100%; bophahamo: koloi; fonte-lelapa: 'Inter', tsamaiso-ui, sans-serif; mmala: #1e293b; --tjhate e kgutsitseng: #64748b;" karolo="img" aria-labelledby="pcac-vote-tallies-by-peptide-title pcac-vote-tallies-by-peptide-desc"> <setaele> /* Mofani o kenya chate ho iframe eo bokamorao ba eona bo leng botšo, mme iframe ke sebopeho se fapaneng le chate, kahoo lihlopha tsa lebokose la litlhaku li ne li bonahala e le liforeimi tse ntšo ho e potoloha (tlhahiso 09-22). Tokomane e ka hare ho iframe e pepeneneng ka ho sa feleng; ho penta mona ho akaretsa bokamorao ba lintho, 'me ha chate e kentsoe ka mola sebakeng sena sena ha se amane le letho. Boloka li-angle brackets kantle ho boloko bona: setaele se kahare ho SVG se arotsoe joalo ka litaba tsa kantle ho naha, kahoo bracket e le 'ngoe e khelohileng e lahla molao o mong le o mong o ho eona. */ html, mmele { bokamorao: #ffffff; moeling: 0; } @media (e ratang-e fokotsehile: fokotsa) { * { animation: ha ho letho !bohlokoa; phetoho: ha ho letho !bohlokoa; } } </setaele> <hantle x="0" y="0" bophara="560" bophahamo="380" rx="8" tlatsa="#ffffff" /> <title id="pcac-vote-tallies-by-peptide-sehloho">Lipalo tsa likhetho tsa PCAC ka peptide</sehlooho> <desc id="pcac-vote-tallies-by-peptide-desc">Lipalo tsa likhetho tsa PCAC ka peptide, joalo ka ha e reriloe ho tsoa mohloling o boletsoeng. Lipalo tsa likhetho tsa PCAC ka peptide. data ea bar e hlophisitsoeng: BPC-157: Bakeng sa 8, Khahlanong le 6, Ila 1; KPV: Bakeng sa 8, Khahlanong le 6, Ila 1; TB-500: Bakeng sa 8, Khahlanong le 6, Ila 1; c-MANTSOE: Bakeng sa 7, Khahlanong le 5, Ila 2; Se mamele: Bakeng sa 8, Khahlanong le 5, Ila 1; Epitalon: Bakeng sa 7, Khahlanong le 4, Ila 1; Emideltide: Bakeng sa 6, Khahlanong le 7, Ila 1.Mohloli: Bass Berry & Sims, tlhokomeliso ea bareki mabapi le khetho ea PCAC 2026-07-31.</desc> <mongolo x="280.0" y="29" mongolo-ankora="bohareng" boholo ba fonte="18" boima ba fonte="800" tlatsa="joaleMmala">Lipalo tsa likhetho tsa PCAC ka peptide</mongolo> <mola x1="72" y1="277.0" x2="492" y2="277.0" stroke="joaleMmala" opacity="0.08" /> <mola x1="72" y1="230.8" x2="492" y2="230.8" stroke="joaleMmala" opacity="0.08" /> <mola x1="72" y1="184.5" x2="492" y2="184.5" stroke="joaleMmala" opacity="0.08" /> <mola x1="72" y1="138.2" x2="492" y2="138.2" stroke="joaleMmala" opacity="0.08" /> <mola x1="72" y1="92.0" x2="492" y2="92.0" stroke="joaleMmala" opacity="0.08" /> <mongolo x="66" y="281.0" mongolo-ankora="QETA" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.7">0</mongolo> <mongolo x="66" y="234.8" mongolo-ankora="QETA" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.7">2.5</mongolo> <mongolo x="66" y="188.5" mongolo-ankora="QETA" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.7">5</mongolo> <mongolo x="66" y="142.2" mongolo-ankora="QETA" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.7">7.5</mongolo> <mongolo x="66" y="96.0" mongolo-ankora="QETA" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.7">10</mongolo> <hantle x="72.0" y="62" bophara="10" bophahamo="10" tlatsa="#f97316" /> <mongolo x="87.0" y="71" boholo ba fonte="11" tlatsa="joaleMmala">Bakeng sa</mongolo> <hantle x="127.6" y="62" bophara="10" bophahamo="10" tlatsa="#38bdf8" /> <mongolo x="142.6" y="71" boholo ba fonte="11" tlatsa="joaleMmala">Khahlanong le</mongolo> <hantle x="208.0" y="62" bophara="10" bophahamo="10" tlatsa="#a78bfa" /> <mongolo x="223.0" y="71" boholo ba fonte="11" tlatsa="joaleMmala">Ila</mongolo> <hantle x="79.0" y="129.0" bophara="13.3" bophahamo="148.0" tlatsa="#f97316" /> <mongolo x="85.7" y="125.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">8</mongolo> <hantle x="94.3" y="166.0" bophara="13.3" bophahamo="111.0" tlatsa="#38bdf8" /> <mongolo x="101.0" y="162.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">6</mongolo> <hantle x="109.7" y="258.5" bophara="13.3" bophahamo="18.5" tlatsa="#a78bfa" /> <mongolo x="116.3" y="254.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">1</mongolo> <mongolo x="102.0" y="295.0" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.8"><tspan x="102.0" dy="0">BPC-157</tspan></mongolo> <hantle x="139.0" y="129.0" bophara="13.3" bophahamo="148.0" tlatsa="#f97316" /> <mongolo x="145.7" y="125.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">8</mongolo> <hantle x="154.3" y="166.0" bophara="13.3" bophahamo="111.0" tlatsa="#38bdf8" /> <mongolo x="161.0" y="162.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">6</mongolo> <hantle x="169.7" y="258.5" bophara="13.3" bophahamo="18.5" tlatsa="#a78bfa" /> <mongolo x="176.3" y="254.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">1</mongolo> <mongolo x="162.0" y="295.0" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.8"><tspan x="162.0" dy="0">KPV</tspan></mongolo> <hantle x="199.0" y="129.0" bophara="13.3" bophahamo="148.0" tlatsa="#f97316" /> <mongolo x="205.7" y="125.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">8</mongolo> <hantle x="214.3" y="166.0" bophara="13.3" bophahamo="111.0" tlatsa="#38bdf8" /> <mongolo x="221.0" y="162.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">6</mongolo> <hantle x="229.7" y="258.5" bophara="13.3" bophahamo="18.5" tlatsa="#a78bfa" /> <mongolo x="236.3" y="254.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">1</mongolo> <mongolo x="222.0" y="295.0" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.8"><tspan x="222.0" dy="0">TB-500</tspan></mongolo> <hantle x="259.0" y="147.5" bophara="13.3" bophahamo="129.5" tlatsa="#f97316" /> <mongolo x="265.7" y="143.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">7</mongolo> <hantle x="274.3" y="184.5" bophara="13.3" bophahamo="92.5" tlatsa="#38bdf8" /> <mongolo x="281.0" y="180.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">5</mongolo> <hantle x="289.7" y="240.0" bophara="13.3" bophahamo="37.0" tlatsa="#a78bfa" /> <mongolo x="296.3" y="236.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">2</mongolo> <mongolo x="282.0" y="295.0" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.8"><tspan x="282.0" dy="0">c-MANTSOE</tspan></mongolo> <hantle x="319.0" y="129.0" bophara="13.3" bophahamo="148.0" tlatsa="#f97316" /> <mongolo x="325.7" y="125.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">8</mongolo> <hantle x="334.3" y="184.5" bophara="13.3" bophahamo="92.5" tlatsa="#38bdf8" /> <mongolo x="341.0" y="180.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">5</mongolo> <hantle x="349.7" y="258.5" bophara="13.3" bophahamo="18.5" tlatsa="#a78bfa" /> <mongolo x="356.3" y="254.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">1</mongolo> <mongolo x="342.0" y="295.0" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.8"><tspan x="342.0" dy="0">Se mamele</tspan></mongolo> <hantle x="379.0" y="147.5" bophara="13.3" bophahamo="129.5" tlatsa="#f97316" /> <mongolo x="385.7" y="143.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">7</mongolo> <hantle x="394.3" y="203.0" bophara="13.3" bophahamo="74.0" tlatsa="#38bdf8" /> <mongolo x="401.0" y="199.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">4</mongolo> <hantle x="409.7" y="258.5" bophara="13.3" bophahamo="18.5" tlatsa="#a78bfa" /> <mongolo x="416.3" y="254.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">1</mongolo> <mongolo x="402.0" y="295.0" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.8"><tspan x="402.0" dy="0">Epitalon</tspan></mongolo> <hantle x="439.0" y="166.0" bophara="13.3" bophahamo="111.0" tlatsa="#f97316" /> <mongolo x="445.7" y="162.0" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">6</mongolo> <hantle x="454.3" y="147.5" bophara="13.3" bophahamo="129.5" tlatsa="#38bdf8" /> <mongolo x="461.0" y="143.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">7</mongolo> <hantle x="469.7" y="258.5" bophara="13.3" bophahamo="18.5" tlatsa="#a78bfa" /> <mongolo x="476.3" y="254.5" mongolo-ankora="bohareng" boholo ba fonte="9" tlatsa="joaleMmala">1</mongolo> <mongolo x="462.0" y="295.0" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="joaleMmala" opacity="0.8"><tspan x="462.0" dy="0">Emideltide</tspan></mongolo> <mongolo x="280.0" y="366" mongolo-ankora="bohareng" boholo ba fonte="10" tlatsa="tsa rona(--tjhate e kgutsitseng, joaleMmala)">Mohloli: Bass Berry & Sims, tlhokomeliso ea bareki mabapi le khetho ea PCAC (2026-07-31)</mongolo> </svg> </setšoantšo>
Lipalesa li bohlokoa ho feta sebopeho sa tsona. BPC-157, KPV le TB-500 ka 'ngoe e nkile 8-6 ka 1 ho ila; MOTS-c e nkile 7–5 ka 2 abstentions; Semax 8–5 ka 1 ho ila; Epitalon 7-4 le 1 ho ila. Emideltide o ile a hlōleha ka tse tšeletseng bakeng sa, tse supileng kgahlanong le e le nngwe ho hana (tafole ea likhetho ka khetho). Mekhahlelo e fapana ho tloha ho 7-4 ho isa ho 8-6, e leng komiti e arotsoeng ka setulo se le seng kapa tse peli holim'a lintho tseo e neng e ikemiselitse ho li khothaletsa.
Ha ho letho le leng lenaneng. Livoutu ke tsa boeletsi, Mongoli oa HHS o tlameha ho amohela ka molao tlatsetso efe kapa efe, 'me li-pharmacy ha li khone ho kopanya li-peptide tsena ho fihlela molao oa ho qetela o le teng, le moo API ea boemo ba meriana e leng teng (tlhahiso ea khoebo ea pharmacy ea likhetho). Lethathamo ka bolona le entsoe ka molao tlas'a karolo ea 503A(c), joalo ka Tsebiso ea kopano ea Federal Register e beha, kahoo kenyelletso ke ketso ea ho etsa melao eseng ketso ea komiti. Ho bala lipalo joalo ka qeto ke mokhoa oa pele oa ho hloleha, mme ke phoso ya ho bala, eseng ea taolo.
Hobaneng ha basebetsi ba FDA ba ile ba hanyetsa li-peptide tsohle tse tšeletseng?
Keletso eo e arohaneng e itšetlehile ka khanyetso eo basebetsi ba FDA ba neng ba se ba ntse ba e behile rekotong. Basebetsi ba FDA ba hanne tlatsetso e 'ngoe le e 'ngoe ka mabaka a mararo: ha ho na data e tiileng ea liteko tsa kliniki, mekhoa e sa tsitsang ho tloha ho sehlopha ho ea ho sehlopha, le kotsi ea liketso tse kotsi tsa ho itšireletsa mafung (ho tlaleha ho tsoa kopanong). Tse peli ho tse tharo tseo ke mathata a k'hemistri. Ho se lumellane ha sehlopha ke bothata ba taolo ea tlhahiso, le immunogenicity moelelong oa peptide ke bothata bo boholo ba ho se hloeke le ho bokellana, ke ka hona FDA e kopanyang-tšireletseho thepa lifolakha GHRP-2, GHRP-6, ipamorelin acetate le kisspeptin-10 bakeng sa kotsi ea immunogenicity "ka lebaka la monyetla oa ho kopanya le litšila tse amanang le peptide."
Rekoto ea sebopeho e ne e le tšesaane ka ho khetheha, mekhoa e fumanehang. Li-peptide tsohle ntle le TB-500 li fumanoe "li sa tsejoe hantle ho latela sebopeho sa 'mele le lik'hemik'hale"; KPV e reriloeng ea tranelate le li-gel formulations e ne e se na tlhaiso-leseling e hlokahalang ho lekola litšobotsi tsa physicochemical.; Epitalon e ne e se na lithuto tse hlahlobang ho hlobaela ka tsela e reriloeng ea subcutaneous; Patlisiso ea Semax e ne e le ho litoeba feela, ha ho na data ea tlhekefetso. Bahlahlobisisi ba hlokometse kotsi e khethehileng ea immunogenicity bakeng sa metsoako e nang le ente (tlhahlobo ea litokomane tse khutšoane).
Boitsebahatso ka bobona bo ne bo tsekoa. Bangoli ba FDA ba hlokometse hore mabitso a tloaelehileng a sa lateleng likopano tsa USAN kapa INN a ka hlalosa likarolo tse fapaneng tse sebetsang, le motheo oo oa mahala, letsoai le mefuta ea ester ea moiety e tšoanang e fapana ka physicochemical, boitšoaro ba toxicological le pharmacokinetic, kahoo lebitso feela hase boitsebiso bo ka tšeptjoang (tlhahlobo ea tsela ea §503A). Bakeng sa BPC-157 ka ho khetheha, lintho tse ngata li rekisoa ka tlas'a lebitso le tloaelehileng le nang le likarolo tse fapaneng tse sebetsang, kahoo "ho ka 'na ha se ke ha e-ba le motheo o ka tšeptjoang oa ho netefatsa hore lebitso le fanoeng le lula le tsebahatsa sebopeho le sebōpeho sa lik'hemik'hale tse tšoanang" (tafole ea likhetho ka khetho).
Khanyetso eo ke lik’hemik’hale, eseng ka ho khetheha. Lenaneo le ba arabang le ba araba ka litokomane, 'me libaka tse tšeletseng tse ka tlase ke litokomane.
Na ho ba lethathamong le kopanyang ho bolela hore peptide e amohetsoe, bolokehileng, kapa e sebetsang?
Tlhahlobo ea lenane la bongata e shebana le sebopeho sa 'mele le lik'hemik'hale, polokeho, bopaki ba katleho le tšebeliso ea histori. Ha se ts'ebetso ea tumello ea lithethefatsi tse ncha, empa bopaki ba kliniki bo ka ba bohlokoa haholo ho litekanyetso tsa polokeho le katleho. Lethathamo ha le fane ka tumello ea FDA.
Litsela tsa molao li tšesaane ho feta kamoo sehlooho sa litaba se se bolelang. Sehlahisoa se kopantsoeng se hloka USP kapa NF monograph, kapa sethethefatsi seo e leng karolo ea sethethefatsi se amohetsoeng ke FDA, kapa sebaka ho Lethathamo la 503A Bulks (the Gku Peptide Tsebiso ea kopano ea Federal Register). Tekanyetso ea lenane la bongata ha se tumello ea lithethefatsi: lethathamo le fetola mekhoa e mene, eseng litekong tse bontšang polokeho le katleho (tlhahlobo ea tsela ea §503A).
Mokhoa oa ho fihlella oa nako e haufi e kanna oa ba khetho ea nakoana ea ts'ebetso, mohlomong ho tsamaisa li-peptide ho Sehlopha 1 ea leano la nakoana la bongata. Seo ha se fetole molao, ha e lumelle sehlahisoa sefe kapa sefe, e ke ke ea fana ka lihlahisoa tsa tšebeliso ea lipatlisiso feela, tlatsetso kapa 503B lits'ebeletso tsa kantle ho naha, e ne e ke ke ea tlama liboto tsa naha, mme e ka fokotswa kapa ya hulwa ntle le tsebiso (ea October 2026 tlhahlobo ea ts'ebetsong). Ts'ebetso ha e ea emisa bakeng sa khetho: FDA e fane ka mangolo a mahlano a lemosang ho barekisi ba li-peptide ba inthaneteng ka 24 Phato 2026, ho fumana hore ho ngolla liphuputso feela ho ne ho sa fete bopaki ba tšebeliso e reriloeng ea batho (ea October 2026 tlhahlobo ea ts'ebetsong).
Mekhoa e mene ke lense e ka sebelisoang bakeng sa litokomane tsa peptide CMC esita le ntle le ho kopanya, hobane ba botsa lipotso tse tšoanang tseo mohlahlobisisi a li botsang dossier efe kapa efe. Seo ba sa se etsang ke ho nkela tlaleho ea analytical, e leng moo ho dutseng dikarolo tse nne tse latelang.
Ke bopaki bofe ba boitsebiso boo FDA e bo lebelletseng bakeng sa peptide, le mekhoa efe e baloang?
Ho lebeletsoe bonyane mekhoa e 'meli ea orthogonal, mme motswako o tlameha ho netefatsa tatelano ntle le pelaelo. Tataiso ea EMA synthetic-peptide e khothaletsa bonyane mekhoa e 'meli ea boitsebahatso ba orthogonal bakeng sa litlhaloso le tokollo., e nkiloeng ka bongata, nako e lekanyelitsoeng ea ho boloka, LC-MS, LC-MS/MS, 'mapa oa peptide, bioactivity, tlhahlobo ea amino acid kapa NMR, le mokopi ea ikarabellang bakeng sa ho bontša motsoako o khethiloeng o tiisa tatellano (tataiso ea EMA synthetic-peptide).
Molao-motheo oa motheo ke oa khale le o pharaletseng. Liteko tsa boitsebiso li lokela ho ba tse tobileng haholo 'me li ipapise le likarolo tse ikhethang tsa sebopeho sa limolek'hule, le liteko tse fetang bonngoe, khemikhale ya mmele, bioloji kapa immunochemical, ho ka hlokahala; sebopeho sa amino acid e rehiloe e le tlhaiso-leseling e sebetsang bakeng sa li-peptide le liprotheine tse nyane (Ke Q6B). ICH Q6B ha e kenyeletse li-peptide tsa maiketsetso sebakeng sa eona mme e hanana le tataiso ea lintho tsa lik'hemik'hale., empa boitsebahatso ba eona ke bona bo sebelisoang ke balaoli.
Mokhoa oa ho hloleha o ngotsoe. Mabitso a bofokoli a tloaelehileng a FDA a itšetlehile ka mokhoa o le mong o tloaelehileng oa HPLC le litlhōrō tse khetholloang feela ka nako e lekanyelitsoeng ea ho boloka e le ho hlōleha khafetsa., 'me e supa UHPLC-HRMS/MS bakeng sa boitsebiso bo holimo le bohloeki bo holimo (Lethathamo la FDA la mefokolo e tloaelehileng). Netefatso e le 'ngoe ea batho ba bangata e araba potso e fapaneng le e boletsoeng.
Bonyane rekoto ea boitsebiso e na le mofuta oa tatellano, ea N- le C-terminus joalo ka ha e kopantsoe, sebaka sa phetoho le k'hemistri, foromo ea counterion, nomoro ea lotho, sekhetho sa mokhoa, kholomo, gradient le wavelength ya ho lemoha, Fektheri ea Boitsebiso ea Peptide le tekanyetso e sebelisoang. The counterion ke ea lethathamong leo hobane peptide e tšoanang le free base le acetate ha se ntho e tšoanang ea lithethefatsi., 'me kopano e ile ea hlahloba mefuta e 'meli bakeng sa ntho e' ngoe le e 'ngoe.
MOL Changes e hlalosa HPLC le liteko tsa spectrometric tse ngata har'a litšebeletso tsa eona. Bohloeki ba sebaka sa HPLC hammoho le boima bo sa fetoheng ha bo joalo, ka boyona, theha boitsebiso ba tatellano, phetolo e khethehileng ea sebaka kapa sephutheloana sa boitsebiso ba orthogonal. Kopa mekhoa le bopaki bo hlokahalang bakeng sa kaho le ts'ebeliso e reriloeng.
Hobaneng ha peresente e le 'ngoe ea bohloeki ba HPLC e sa lekana, le eng hape e lokelang ho lekanyetsoa?
Bohloeki, boitsebiso, litaba le boemo ba litšila ke litekanyo tse 'ne, 'me palo ea sebaka sa sebaka e araba feela karolo ea e le 'ngoe. Ho thata ho tseba ho hloeka ka ho feletseng 'me liphello li itšetlehile ka mokhoa, kahoo ho hloeka ho hakanngoa ka ho kopanya mekhoa ho e-na le chromatogram e le 'ngoe (Tlhaloso ea ICH Q6B ea bohloeki). ICH Q6B e thathamisa mekhoa ea bohloeki ka thoko ho mekhoa ea litšila, ke kahoo nomoro e le 'ngoe e ke keng ea sebetsa joalo ka tlhaloso.
Melemo e fapana ho ea ka tsamaiso, mme boima ba molao bo fapane le bona. Bakeng sa li-peptide tsa maiketsetso, thuto ea Ph. EUR. monograph e akaretsang ea lintho tse sebelisoang meriana e beha litšila tse amanang le peptide tse lokelang ho tlalehoa ka holimo. 0.1%, e boletsoeng ka holimo 0.5% mme a tshwaneleha ka hodimo 1.0%, 'me tataiso ea EMA e sebetsa menyako e tšoanang ho lihlahisoa tse felileng (tataiso ea EMA synthetic-peptide). Ke Q3A(R2) e beha boleng bo fapaneng bakeng sa litšila tsa lithethefatsi ka tekanyo e phahameng ea letsatsi le letsatsi ea 2 g/letsatsi kapa ka tlase ho moo: tlaleho 0.05%, boitsebiso 0.10% kapa 1.0 mg/letsatsi ho sa tsotelehe hore na ke efe e tlase, qualification 0.15% kapa 1.0 mg/letsatsi (Ke Q3A(R2) dipehelo le ditekanyetso tsa thuto). Tataiso ea EMA e bolela hore li-peptide tsa maiketsetso ha li kenyellelitsoe ho ICH Q3A le hore meeli ea eona ha e sebetse., kahoo litepisi tse peli ha li fetohe.
Tataiso e tobileng ea sehlahisoa sa FDA bakeng sa semaglutide, e ntlafalitsoe ka Phupu 2026, e sebelisa le 0.1% le 0.5% tlaleha le ho hloaea lipalo empa o eketsa ntlha e lekanyelitsoeng: litšila ka 'ngoe tse arolelanoang ha lia lokela ho feta tekanyo ea lithethefatsi e thathamisitsoeng kapa 1.0%, leha e le efe e kgolo, litšila tse ncha li lokela ho fokotsoa ka tlase 1.0%, le litšila tse amanang le motsoako o sebetsang kaofela ha lia lokela ho feta sehlahisoa sa litšupiso (ea July 2026 tataiso e tobileng ea sehlahisoa). Tokomane e tšoailoe hore ke moralo o hlophisitsoeng eseng oa ts'ebetsong, 'me e tobane le sehlahisoa, kahoo ha e behe moeli o akaretsang oa peptide.
Tataiso ea peptide ea EU le moralo o ikhethileng oa semaglutide oa US o na le maemo a fapaneng. Lekola sehlahisoa sa sebele le litekanyetso tsa ho se hloeke; moeli oa tlaleho kapa oa ho fumana mangolo ha se moeli oa tokollo, 'me papiso ea semaglutide e ke ke ea hlalosa kamohelo ea US ea peptide e' ngoe le e 'ngoe.
U paka joang hore motho o khona ho ikatisa le mokhoa o bontšang botsitso?
Ho ikatisa ho bontšoa ke rekoto ea lotho e hokahaneng le mokhoa o netefalitsoeng oa ho lemoha ho senyeha, eseng ka litifikeiti tse tharo tseo se seng le se seng se tlalehang karolo e phahameng. Tataiso ea EMA e hloka hore thepa e bonts'ang botsitso le tekanyo ea boima ba mokhoa o ithutoe, 'me e tšoara ho fumaneha ka nako ea mekhoa e bontšang botsitso ka tharollo e ntle ea tlhoro le tekanyo e ntle ea boima e le tlhokahalo. (tataiso ea EMA synthetic-peptide). Lithuto tse qobelloang tsa ho nyenyefatsa li tlameha ho bonts'a ho senyeha ha peptide le bokhoni ba ts'ebetso ea ho e bona..
Li-peptide li etsa konkreite e hlokahalang. Taelo e tšoanang e bontša hore li-peptide li na le ho ba le thermally labile, kahoo ho senyeha ho lokela ho bonoa maemong a sa lokelang a polokelo, mme e thathamisa oxidation ea masala a Cys le Met, timetso, hydrolysis le tatellano e nang le beta-Asp e le litsela tsa ho senyeha ho buisana (tataiso ea EMA synthetic-peptide). Ho thehoa ha litšila tse phahameng tsa molek'hule ho lokela ho batlisisoa nakong ea botsitso moo ho hlokahalang. Fektheri ea Peptide P
Netefatso e na le heke ea eona. Ts'ebetso ea ho se hloeke ka bongata e hloka ho hlaka, sebaka se nang le moeli o tlase ho tekanyo ea palo, nepahalo le nepahalo, le protocol ea netefatso e bolelang sepheo se reriloeng, litšobotsi le litekanyetso li tlameha ho ba teng pele ho thuto (Ke Q2(R2) Tafole 1). Tataiso ea EMA ha e kenye litlhoko tse ling tsa netefatso ho feta tsa lintho tse ling tse sebetsang ka lik'hemik'hale.
Bakeng sa lenaneo la lipatlisiso, tebello ea botsitso e loketse mohato ho e-na le ho qetela. Lintlha tsa botsitso lia hlokahala likarolong tsohle ho bontša hore ntho e lula ka har'a meeli e amohelehang ea lik'hemik'hale le 'mele bakeng sa nako e reriloeng., 'me moo ho hlahisoang liteko tsa nako e khuts'oane haholo, lintlha tse tšehetsang li ka fokotsoa ka tsela e tšoanang (21 CFR 312.23).
Rekoto ea lotho e hokahaneng e shebahala tjena: nomoro ea lotho, chromatogram e nang le sekhetho sa mokhoa le maemo a referense, sephetho se qobelloang sa ho nyenyefatsa se bonts'ang mokhoa o rarollang ba nyenyefatsang, le protocol ea botsitso e nang le boemo ba eona ba polokelo le linako tsa nako. Kelello-up ke moo rekoto hangata e robehang, hobane boemo bo fetohileng ba ho se hloeke bo bonoang lihlopheng tsa lifofane kapa tsa khoebo bo tlameha ho bapisoa le datha ea pejana le phello ea eona ho boleng le ho data ea bongaka le ea pele ho kliniki eo ho buisanoeng ka eona. (tataiso ea EMA synthetic-peptide).
Peptide e hloka eng pele ho puisano ea pele ho IND?
Tlaleho ea kliniki ke eona heke e fokolang ka ho fetisisa le e behang nako ea nako, hobane sephutheloana sa tlhahlobo se ka tsosolosoa ka potlako ho feta kamoo data ea motho e ka hlahisoang kateng. Bahlahlobisisi ba FDA ha ba fumane karolo e phethiloeng 3 liteko tse sa reroang ho li-peptide tsohle tse tšeletseng tse khothalelitsoeng, le ho hlahloba liteko tse hlano tse nyenyane tsa batho bakeng sa BPC-157 (tlaleho ea sebopeho sa komiti). Peptide e matla
Palo ea peptide e tšesaane ho feta kamoo voutu e bolelang. Ka tlase ho 36 litaba tsa batho ka bophara 3 lithuto li tšehetsa BPC-157, e nang le thuto ea ente ea lengole ea 16, thuto ea ente ea senya ea bakuli ba 12 le thuto ea infusion ea litaba tse 2, le liphoofolo tse ling tsohle tsa bopaki ba BPC-157; KPV, MOTS-c le TB-500 li bile le khaello e felletseng ea lithuto ho batho ka tsela efe kapa efe; Lintlha tsa Semax li lekantsoe lithutong tse sa lekaneng tse etsoang kantle ho naha eseng tlasa IND; Liteko tsa batho tsa Epitalon li ile tsa sebetsa Russia le Ukraine ka ntle ho bolebeli ba FDA kapa ICH-e lumellanang le mekhoa e metle ea bongaka. (tlhaloso ea docket e kopanyang lintlha tsa motho).
Litebello tsa pharmacology li khethehile ka peptide 'me li ntse li le teng. Tataiso e hlophisitsoeng ea FDA mabapi le pharmacology ea bongaka bakeng sa lihlahisoa tsa lithethefatsi tsa peptide, e hatisitsoeng ka December 2023 mme e sa tshwauwe bakeng sa ho kenngwa tshebetsong, e phekola ho fokola ha sebete, likamano tsa lithethefatsi le lithethefatsi, Kotsi ea ho lelefatsa ha QTc le kotsi ea ho itšireletsa mafung joalo ka lintlha tse ikhethileng tsa peptide (Tataiso e hlophisitsoeng ea FDA ea peptide ea bongaka ea bongaka). Maikutlo a indasteri ho docket a pheha khang ea hore kotsi ea ho sebelisana le lithethefatsi tsa pharmacokinetic le li-peptide e tlase., hore li-peptide hangata ha li CYP-metabolized, le hore biomarker e le 'ngoe e kanna ea se lekane, ka tse peli kapa ho feta tse tšehetsang kutloisiso e betere ea polokeho le katleho (maikutlo a indasteri ho docket). Tsena ke maemo a lehlakoreng la bafani, eseng litlhoko tsa setsi.
Mokhoa oa ts'ebetso o teng. Kopano ea pele ho IND ke sehlopha se tsebahalang sa kopano sa Mofuta oa B tlas'a moralo oa liboka oa FDA bakeng sa lihlahisoa tsa PDUFA. (Tataiso ea liboka tsa FDA tsa PDUFA). Seo melaoana e sa se etseng ke ho beha litaba tse ikhethileng tsa peptide: 21 CFR 312.23 e hloka meeli e amohelehang le mekhoa ea tlhahlobo bakeng sa boitsebiso, matla, boleng le bohloeki, mme o bolela hore ditlhaloso tsa ho qetela ha di a lebellwa ho fihlela qetellong ya tshebetso ya dipatlisiso (21 CFR 312.23). Sengoliloeng sena ha se keletso ea taolo; lenaneo le lokela ho netefatsa sephutheloana sa lona khahlano le tataiso ea hajoale le FDA ka kotloloho.
Libaka tse tšeletseng li kopana joang ho etsa qeto e le 'ngoe ea ho itokisetsa?
Libaka tse tšeletseng li etsa tatelano ea liheke, mme heke e fokolang ka ho fetisisa e beha kemiso ea nako ho e-na le karolelano. Heke ea pele ke boitsebiso: bonyane mekhoa e 'meli ea orthogonal eo motsoako oa eona o tiisang tatellano (tataiso ea EMA synthetic-peptide). Heke ea bobeli ke purity plus mass balance, ka mokhoa o bonts'ang botsitso boo lihlahisoa tsa bona tsa ho senyeha li hlileng li lemohuoang. Heke ea boraro ke boemo ba ho se hloeke bo isitsoeng ho monyako o sebetsang, ka litlhoro tse kopaneng li rarollotsoe kapa tlhoro e kopaneng e tšoanelehang.
Lekola nalane ea sehlopha ka lisampole tse nepahetseng le moralo oa papiso. Q2(R2) e sebetsana le netefatso ea ts'ebetso ea tlhahlobo; ha se maemo a netefatso ea tšebetso kapa palo ea palo e ngata.
Lekola litsebiso tsa FDA bakeng sa kopano efe kapa efe ea boeletsi ea peptide le litaba tsa eona. Fesetere ea liboka tsa bolepi ha se tlhahlobo e felletseng kapa letsatsi le tiisitsoeng la pholisi.
Lipotso Tse Botsoang Khafetsa
E etsahetse ka Phupu 2026 likhetho eketsa li-peptide tsena Lethathamong la 503A Bulks?
Che. Komiti e khothalelitse tse tšeletseng ho tse supileng, mme khothaletso ke ea boeletsi. Ntho e fihla lenaneng feela ka ho etsa tsebiso-le-maikutlo tlas'a karolo ea 503A(c), mme ho fihlela ho hlaha molao wa ho qetela, ho kopanya li-peptide tsena ho lula kantle ho boema-kepe bo sireletsehileng ba 503A (tsebiso ea kopano ea Federal Register).
Ke a 98% Phello ea bohloeki ba HPLC e lekaneng bakeng sa tlhaloso ea peptide?
Che. Bohloeki bo itšetlehile ka mokhoa 'me bo hakanyetsoa ka mekhoa e mengata, le ICH Q6B e thathamisa mekhoa ea bohloeki ka thoko ho mekhoa ea litšila (Tlhaloso ea ICH Q6B ea bohloeki). Tlhaloso e boetse e hloka boitsebiso ka mekhoa e 'meli ea orthogonal, boemo bo sa hloekang ho fihla moo ho sebetsang teng, litaba tse ka har'a counterion-free anhydrous basis, le mokhoa o bontšang botsitso.
Ke menyako efe ea litšila e sebetsang ho peptide ea maiketsetso?
E itšetlehile ka puso. Litsebi tsa Ph. EUR. menyako e boletsoeng hape ho tataiso ea EMA ke tlaleho e kaholimo 0.1%, tsebahatsa ka holimo 0.5% le ho tšoaneleha ka holimo 1.0% (tataiso ea EMA synthetic-peptide). Ke Q3A(R2) lihlopha 0.05%, 0.10% le 0.15% ka tekanyo e kholo ea letsatsi le letsatsi ea 2 g/letsatsi kapa ka tlase ho moo, mme tataiso ea EMA e re meeli eo ha e sebetse ho li-peptide tsa maiketsetso (Ke Q3A(R2) dipehelo le ditekanyetso tsa thuto).
Ke lintlha life tsa batho tse neng li le teng bakeng sa li-peptide tse khothalelitsoeng tse tšeletseng?
Bahlahlobi ba FDA ha ba fumane karolo e phethiloeng 3 liteko tse sa reroang ho pholletsa le tse tšeletseng (tlaleho ea sebopeho sa komiti). Maikutlo a docket a baloa ka tlase ho 36 litaba ka bophara 3 Lithuto tsa BPC-157, ha ho lithuto tsa tsamaiso ea batho bakeng sa KPV, MOTS-c kapa TB-500, le lithuto tsa kantle ho naha bakeng sa Semax le Epitalon tse entsoeng kantle ho ts'ebetso e ntle ea bongaka ea IND kapa ICH (tlhaloso ea docket e kopanyang lintlha tsa motho).
Qetello
Khetho e ne e le khothaletso e arohaneng holim'a mekhoa e mene ea molao, 'me likhanyetso ka mor'a karohano e ne e le lik'hemik'hale le litokomane: boitsebiso boo lebitso le ke keng la tiisa, litlaleho tsa litšila tseo chromatogram e le 'ngoe e ke keng ea li theha, ho se tsitsane ha sehlopha, le rekoto ea kliniki eo maemong a mangata e seng teng. Cheke ea li-domain tse tšeletseng e fetola likhanyetso tseo lenaneng la mosebetsi, le heke e fokolang, hangata litokomane tsa kliniki, e beha kemiso ea nako.
Mohato o latelang ke ho tsamaisa liheke tse tšeletseng khahlanong le tatellano e le 'ngoe le ho tlaleha moo bopaki bo emisang. Lenaneo le ka bolelang mekhoa ea lona ea boitsebiso, menyako ea ho se hloeke ha eona le boima ba eona ba molao, sephetho sa eona se qobelletsoe ho theoloa, nalane ea eona ea lotho le boemo ba data ba batho bo na le sephutheloana sa basebetsi ba FDA ba boletseng hore ha se eo, 'me e na le eona pele sehlopha sa bobeli sa mabitso se fihla komiting.
Phatlalatso ea mohatisi: MOL Changes e fana ka litšebeletso tsa peptide mme e na le thahasello ea khoebo sehloohong sena. Mekhahlelo ea litšebeletso le lipolelo tsa bokhoni ke likopo tsa bafani ba thepa; ho fumaneha le ts'ebetso bakeng sa moaho o itseng o hloka bopaki bo ikhethileng ba projeke.
