Into yeziyobisi ibhekiselele kwiziyobisi ezisetyenziselwa ukuveliswa kwamalungiselelo ahlukeneyo. Sisithako esisebenzayo kumalungiselelo. Ingumgubo, i-crystal, i-extract, njl. elungiselelwe yi-chemical synthesis, i-plant extraction okanye i-biotechnology kwaye isetyenziswe njengeyeza, kodwa ayikwazi ukuthathwa ngokuthe ngqo kwizigulane.

Inkcazo egqibeleleyo ye-API kwi-ICH Q7A: nayiphi na into okanye umxube wezinto ezijoliswe ukuba zisetyenziswe ekwenzeni amachiza kwaye zibe sisithako esisebenzayo samachiza xa zisetyenziswa kumayeza. Le nto inomsebenzi we-pharmacological okanye ezinye iziphumo ezithe ngqo kwi-diagnostic, unyango, ukukhululeka kweempawu, unyango okanye ukuthintela izifo zezifo, okanye kunokuchaphazela umsebenzi okanye isakhiwo somzimba.

Isithako esisebenzayo sechiza. Kuphela xa izinto eziluhlaza zicutshungulwa kumalungiselelo amayeza zinokuthi zibe liyeza lokusetyenziswa kweklinikhi.

I-API inokwahlulwa ibe ngamacandelo amabini ngokomthombo wayo: iziyobisi zokwenziwa kweekhemikhali kunye neziyobisi zendalo.

Amachiza okwenziwa kweekhemikhali anokwahlulwa abe ngamachiza enziwe nge-inorganic kunye ne-organic synthetic drug. Iziyobisi zokwenziwa kwe-inorganic zikhompawundi ze-inorganic (zimbalwa kakhulu zizinto), ezifana ne-aluminium hydroxide kunye ne-magnesium trisilicate esetyenziselwa ukunyanga izilonda zesisu kunye ne-duodenal; Amachiza okwenziwa kwe-Organic ngamachiza ikakhulu (afana ne-aspirin, i-chloramphenicol, i-caffeine, njl.njl.) enziwe ngemathiriyeli esisiseko ye-organic chemical ekrwada ngothotho lwe-organic chemical reaction.

Iziyobisi zendalo zekhemikhali zinokwahlulwa zibe ngamachiza e-biochemical kunye neziyobisi ze-phytochemical ngokwemithombo yazo. Ii-antibiotics ziveliswa ngokubanzi ngokuvutshelwa kwe-microbial kwaye ziyinxalenye ye-biochemistry. Kwiminyaka yakutshanje, iintlobo ze-antibiotics ze-semi-synthetic ziyimveliso edibanisa i-biosynthesis kunye ne-chemical synthesis. Phakathi kwemathiriyeli ekrwada, iindidi, imveliso kunye nexabiso lemveliso ye-organic synthetic drug akhawunti yeyona nxalenye inkulu kwaye yintsika ephambili yeshishini loxubo lwamayeza. Umgangatho wezinto eziluhlaza umisela umgangatho wamalungiselelo, ngoko ke imigangatho yomgangatho wayo ingqongqo kakhulu. Amazwe kwihlabathi jikelele aqulunqe imigangatho engqongqo ye-pharmacopoeia yesizwe kunye neendlela zokulawula umgangatho wezinto ezisetyenziswayo ezisetyenziswa ngokubanzi.

Into yeziyobisi ibhekiselele kwiziyobisi ezisetyenziselwa ukuveliswa kwamalungiselelo ahlukeneyo. Sisithako esisebenzayo kumalungiselelo. Ingumgubo, i-crystal, i-extract, njl. elungiselelwe yi-chemical synthesis, i-plant extraction okanye i-biotechnology kwaye isetyenziswe njengeyeza, kodwa ayikwazi ukuthathwa ngokuthe ngqo kwizigulane.

Inkcazo egqibeleleyo ye-API kwi-ICH Q7A: nayiphi na into okanye umxube wezinto ezijoliswe ukuba zisetyenziswe ekwenzeni amachiza kwaye zibe sisithako esisebenzayo samachiza xa zisetyenziswa kumayeza. Le nto inomsebenzi we-pharmacological okanye ezinye iziphumo ezithe ngqo kwi-diagnostic, unyango, ukukhululeka kweempawu, unyango okanye ukuthintela izifo zezifo, okanye kunokuchaphazela umsebenzi okanye isakhiwo somzimba.

Isithako esisebenzayo sechiza. Kuphela xa izinto eziluhlaza zicutshungulwa kumalungiselelo amayeza zinokuthi zibe liyeza lokusetyenziswa kweklinikhi.

I-API inokwahlulwa ibe ngamacandelo amabini ngokomthombo wayo: iziyobisi zokwenziwa kweekhemikhali kunye neziyobisi zendalo.

Amachiza okwenziwa kweekhemikhali anokwahlulwa abe ngamachiza enziwe nge-inorganic kunye ne-organic synthetic drug. Iziyobisi zokwenziwa kwe-inorganic zikhompawundi ze-inorganic (zimbalwa kakhulu zizinto), ezifana ne-aluminium hydroxide kunye ne-magnesium trisilicate esetyenziselwa ukunyanga izilonda zesisu kunye ne-duodenal; Amachiza okwenziwa kwe-Organic ngamachiza ikakhulu (afana ne-aspirin, i-chloramphenicol, i-caffeine, njl.njl.) enziwe ngemathiriyeli esisiseko ye-organic chemical ekrwada ngothotho lwe-organic chemical reaction.

Iziyobisi zendalo zekhemikhali zinokwahlulwa zibe ngamachiza e-biochemical kunye neziyobisi ze-phytochemical ngokwemithombo yazo. Ii-antibiotics ziveliswa ngokubanzi ngokuvutshelwa kwe-microbial kwaye ziyinxalenye ye-biochemistry. Kwiminyaka yakutshanje, iintlobo ze-antibiotics ze-semi-synthetic ziyimveliso edibanisa i-biosynthesis kunye ne-chemical synthesis. Phakathi kwemathiriyeli ekrwada, iindidi, imveliso kunye nexabiso lemveliso ye-organic synthetic drug akhawunti yeyona nxalenye inkulu kwaye yintsika ephambili yeshishini loxubo lwamayeza. Umgangatho wezinto eziluhlaza umisela umgangatho wamalungiselelo, ngoko ke imigangatho yomgangatho wayo ingqongqo kakhulu. Amazwe kwihlabathi jikelele aqulunqe imigangatho engqongqo ye-pharmacopoeia yesizwe kunye neendlela zokulawula umgangatho wezinto ezisetyenziswayo ezisetyenziswa ngokubanzi.