Discussion: According to EMEA and FDA guidelines, a pharmacokinetic study should be carried out during the development phase of a new drug that is likely to be used in patients with renal dysfunction and whose pharmacokinetics are likely to be significantly altered in these patients. This study should be carried out in carefully selected subjects with varying degrees of renal dysfunction. In addition to this two-stage pharmacokinetic approach, a population PK/PD study in patients participating in phase II/phase III clinical trials can also be used to assess the impact of renal dysfunction on the drug's pharmacokinetics and pharmacodynamics.
What is the graph of most enzymatic reactions following Michaelis-Menten kinetics? What do the axises represent?","front_plain":"What is the graph of most enzymatic reactions following Michaelis-Menten kinetics? What do the axises represent?","back":"Most follow a hyperbolic curve; however, enzymatic reactions that exhibit a sigmoid curve usually indicate cooperative kinetics (eg, hemoglobin)Y-axis = Velocity (V)X-axis = [S]","back_plain":"Most follow a hyperbolic curve; however, enzymatic reactions that exhibit a sigmoid curve usually indicate cooperative kinetics (eg, hemoglobin)\n\nY-axis = Velocity (V)\nX-axis = [S]","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/23\/5245723.png","hint":"","hint_plain":"","card_id":0,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=1967b40&s=V2hhdCBpcyB0aGUgZ3JhcGggb2YgbW9zdCBlbnp5bWF0aWMgcmVhY3Rpb25zIGZvbGxvd2luZyBNaWNoYWVsaXMtTWVudGVuIGtpbmV0aWNzPyBXaGF0IGRvIHRoZSBheGlzZXMgcmVwcmVzZW50Pw%3D%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=55793d1&s=TW9zdCBmb2xsb3cgYSBoeXBlcmJvbGljIGN1cnZlOyBob3dldmVyLCBlbnp5bWF0aWMgcmVhY3Rpb25zIHRoYXQgZXhoaWJpdCBhIHNpZ21vaWQgY3VydmUgdXN1YWxseSBpbmRpY2F0ZSBjb29wZXJhdGl2ZSBraW5ldGljcyAoZWcsIGhlbW9nbG9iaW4pCgpZLWF4aXMgPSBWZWxvY2l0eSAoVikKWC1heGlzID0gW1Nd","audio_hint":null},"front":"According to the Michaelis-Menten equation, what does Km equal?","front_plain":"According to the Michaelis-Menten equation, what does Km equal?","back":"Km = [S] at 1\/2 Vmax","back_plain":"Km = [S] at 1\/2 Vmax","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/02\/5245702.png","hint":"","hint_plain":"","card_id":1,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=f80de92&s=QWNjb3JkaW5nIHRvIHRoZSBNaWNoYWVsaXMtTWVudGVuIGVxdWF0aW9uLCB3aGF0IGRvZXMgS20gZXF1YWw%2F","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=c1fb127&s=S20gPSBbU10gYXQgMS8yIFZtYXg%3D","audio_hint":null,"front":"What is Km (of the Michaelis-Menten equation) related to?","front_plain":"What is Km (of the Michaelis-Menten equation) related to?","back":"Related to the affinity of the enzyme for its substrate","back_plain":"Related to the affinity of the enzyme for its substrate","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/05\/5245705.png","hint":"","hint_plain":"","card_id":2,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=165a105&s=V2hhdCBpcyBLbSAob2YgdGhlIE1pY2hhZWxpcy1NZW50ZW4gZXF1YXRpb24pIHJlbGF0ZWQgdG8%2F","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=7d27790&s=UmVsYXRlZCB0byB0aGUgYWZmaW5pdHkgb2YgdGhlIGVuenltZSBmb3IgaXRzIHN1YnN0cmF0ZQ%3D%3D","audio_hint":null,"front":"What is Vmax (of the Michaelis-Menten equation) related to?","front_plain":"What is Vmax (of the Michaelis-Menten equation) related to?","back":"Directly proportional to the enzyme concentration","back_plain":"Directly proportional to the enzyme concentration","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/08\/5245708.png","hint":"","hint_plain":"","card_id":3,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=c2c5d74&s=V2hhdCBpcyBWbWF4IChvZiB0aGUgTWljaGFlbGlzLU1lbnRlbiBlcXVhdGlvbikgcmVsYXRlZCB0bz8%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=5fe3582&s=RGlyZWN0bHkgcHJvcG9ydGlvbmFsIHRvIHRoZSBlbnp5bWUgY29uY2VudHJhdGlvbg%3D%3D","audio_hint":null,"front":"What is the slope on a Lineweaver-Burk plot? What do the axises represent?","front_plain":"What is the slope on a Lineweaver-Burk plot? What do the axises represent?","back":"Slope = Km \/ VmaxY-axis = 1\/VX-axis = 1\/[S]","back_plain":"Slope = Km \/ Vmax\n\nY-axis = 1\/V\nX-axis = 1\/[S]","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/29\/5245729.png","hint":"","hint_plain":"","card_id":4,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=440ea00&s=V2hhdCBpcyB0aGUgc2xvcGUgb24gYSBMaW5ld2VhdmVyLUJ1cmsgcGxvdD8gV2hhdCBkbyB0aGUgYXhpc2VzIHJlcHJlc2VudD8%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=c8325a3&s=U2xvcGUgPSBLbSAvIFZtYXgKClktYXhpcyA9IDEvVgpYLWF4aXMgPSAxL1tTXQ%3D%3D","audio_hint":null,"front":"What is the X-intercept on a Lineweaver-Burk plot?","front_plain":"What is the X-intercept on a Lineweaver-Burk plot?","back":"1 \/ -Km","back_plain":"1 \/ -Km","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/38\/5245738.png","hint":"","hint_plain":"","card_id":5,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=d7e8506&s=V2hhdCBpcyB0aGUgWC1pbnRlcmNlcHQgb24gYSBMaW5ld2VhdmVyLUJ1cmsgcGxvdD8%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=917e879&s=MSAvIC1LbQ%3D%3D","audio_hint":null,"front":"What is the Y-intercept on a Lineweaver-Burk plot?","front_plain":"What is the Y-intercept on a Lineweaver-Burk plot?","back":"1 \/ Vmax","back_plain":"1 \/ Vmax","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/41\/5245741.png","hint":"","hint_plain":"","card_id":6,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=661e93f&s=V2hhdCBpcyB0aGUgWS1pbnRlcmNlcHQgb24gYSBMaW5ld2VhdmVyLUJ1cmsgcGxvdD8%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=fd544e8&s=MSAvIFZtYXg%3D","audio_hint":null,"front":"What value changes as the Y-intercept increases on a Lineweaver-Burk plot?","front_plain":"What value changes as the Y-intercept increases on a Lineweaver-Burk plot?","back":"As Y-intercept \u2191, Vmax \u2193Remember Y-intercept = 1 \/ Vmax","back_plain":"As Y-intercept \u2191, Vmax \u2193\n\nRemember Y-intercept = 1 \/ Vmax","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/44\/5245744.png","hint":"","hint_plain":"","card_id":7,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=dec30d1&s=V2hhdCB2YWx1ZSBjaGFuZ2VzIGFzIHRoZSBZLWludGVyY2VwdCBpbmNyZWFzZXMgb24gYSBMaW5ld2VhdmVyLUJ1cmsgcGxvdD8%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=e9a5c7e&s=QXMgWS1pbnRlcmNlcHQg4oaRLCBWbWF4IOKGkwoKUmVtZW1iZXIgWS1pbnRlcmNlcHQgPSAxIC8gVm1heA%3D%3D","audio_hint":null,"front":"What value changes as the X-intercept increases (gets closer to zero) on a Lineweaver-Burk plot?","front_plain":"What value changes as the X-intercept increases (gets closer to zero) on a Lineweaver-Burk plot?","back":"The further to the right the x-intercept, the greater the Km and the lower the affinityRemember X-intercept = 1 \/ -Km","back_plain":"The further to the right the x-intercept, the greater the Km and the lower the affinity\n\nRemember X-intercept = 1 \/ -Km","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/50\/5245750.png","hint":"","hint_plain":"","card_id":8,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=b5da183&s=V2hhdCB2YWx1ZSBjaGFuZ2VzIGFzIHRoZSBYLWludGVyY2VwdCBpbmNyZWFzZXMgIChnZXRzIGNsb3NlciB0byB6ZXJvKSBvbiBhIExpbmV3ZWF2ZXItQnVyayBwbG90Pw%3D%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=90129fa&s=VGhlIGZ1cnRoZXIgdG8gdGhlIHJpZ2h0IHRoZSB4LWludGVyY2VwdCwgdGhlIGdyZWF0ZXIgdGhlIEttIGFuZCB0aGUgbG93ZXIgdGhlIGFmZmluaXR5CgpSZW1lbWJlciBYLWludGVyY2VwdCA9IDEgLyAtS20%3D","audio_hint":null,"front":"What happens to the lines of competitive inhibitors on a Lineweaver-Burk plot?","front_plain":"What happens to the lines of competitive inhibitors on a Lineweaver-Burk plot?","back":"Competitive inhibitors cross each other competitively","back_plain":"Competitive inhibitors cross each other competitively","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/57\/98\/5245798.png","hint":"","hint_plain":"","card_id":9,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=977813e&s=V2hhdCBoYXBwZW5zIHRvIHRoZSBsaW5lcyBvZiBjb21wZXRpdGl2ZSBpbmhpYml0b3JzIG9uIGEgTGluZXdlYXZlci1CdXJrIHBsb3Q%2F","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=dce5ecf&s=Q29tcGV0aXRpdmUgaW5oaWJpdG9ycyBjcm9zcyBlYWNoIG90aGVyIGNvbXBldGl0aXZlbHk%3D","audio_hint":null,"front":"What happens to the lines of non-competitive inhibitors on a Lineweaver-Burk plot?","front_plain":"What happens to the lines of non-competitive inhibitors on a Lineweaver-Burk plot?","back":"Non-competitive inhibitors do not cross each other","back_plain":"Non-competitive inhibitors do not cross each other","src":"https:\/\/images.cram.com\/images\/upload-flashcards\/24\/58\/01\/5245801.png","hint":"","hint_plain":"","card_id":10,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=dc1e9d8&s=V2hhdCBoYXBwZW5zIHRvIHRoZSBsaW5lcyBvZiBub24tY29tcGV0aXRpdmUgaW5oaWJpdG9ycyBvbiBhIExpbmV3ZWF2ZXItQnVyayBwbG90Pw%3D%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=96497ac&s=Tm9uLWNvbXBldGl0aXZlIGluaGliaXRvcnMgZG8gbm90IGNyb3NzIGVhY2ggb3RoZXI%3D","audio_hint":null,"front":"Which types of inhibitors resemble the substrate? Which do not?","front_plain":"Which types of inhibitors resemble the substrate? Which do not?","back":"Resemble substrate:- Competitive reversible inhibitors- Competitive irreversible inhibitorsDo not resemble substrate:- Non-competitive inhibitors","back_plain":"Resemble substrate:\n- Competitive reversible inhibitors\n- Competitive irreversible inhibitors\n\nDo not resemble substrate:\n- Non-competitive inhibitors","src":null,"hint":"","hint_plain":"","card_id":11,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=2e34974&s=V2hpY2ggdHlwZXMgb2YgaW5oaWJpdG9ycyByZXNlbWJsZSB0aGUgc3Vic3RyYXRlPyBXaGljaCBkbyBub3Q%2F","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=96d09da&s=UmVzZW1ibGUgc3Vic3RyYXRlOgotIENvbXBldGl0aXZlIHJldmVyc2libGUgaW5oaWJpdG9ycwotIENvbXBldGl0aXZlIGlycmV2ZXJzaWJsZSBpbmhpYml0b3JzCgpEbyBub3QgcmVzZW1ibGUgc3Vic3RyYXRlOgotIE5vbi1jb21wZXRpdGl2ZSBpbmhpYml0b3Jz","audio_hint":null,"front":"Which types of inhibitors can be overcome by \u2191 [S]? Which are not?","front_plain":"Which types of inhibitors can be overcome by \u2191 [S]? Which are not?","back":"Overcome:- Competitive reversible inhibitorsNot overcome:- Competitive irreversible inhibitors- Non-competitive inhibitors","back_plain":"Overcome:\n- Competitive reversible inhibitors\n\nNot overcome:\n- Competitive irreversible inhibitors\n- Non-competitive inhibitors","src":null,"hint":"","hint_plain":"","card_id":12,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=84be368&s=V2hpY2ggdHlwZXMgb2YgaW5oaWJpdG9ycyBjYW4gYmUgb3ZlcmNvbWUgYnkg4oaRIFtTXT8gV2hpY2ggYXJlIG5vdD8%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=d6cb997&s=T3ZlcmNvbWU6Ci0gQ29tcGV0aXRpdmUgcmV2ZXJzaWJsZSBpbmhpYml0b3JzCgpOb3Qgb3ZlcmNvbWU6Ci0gQ29tcGV0aXRpdmUgaXJyZXZlcnNpYmxlIGluaGliaXRvcnMKLSBOb24tY29tcGV0aXRpdmUgaW5oaWJpdG9ycw%3D%3D","audio_hint":null,"front":"Which types of inhibitors canbind the active site? Which do not?","front_plain":"Which types of inhibitors canbind the active site? 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Competitive reversible inhibitors\n\n\u2193 Efficacy:\n- Competitive irreversible inhibitors\n- Non-competitive inhibitors","src":null,"hint":"","hint_plain":"","card_id":16,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=ca63260&s=V2hhdCBpcyB0aGUgcGhhcm1hY29keW5hbWljIGVmZmVjdCBvZiB0aGUgZGlmZmVyZW50IGluaGliaXRvcnM%2F","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=e41a90a&s=4oaTIFBvdGVuY3k6Ci0gQ29tcGV0aXRpdmUgcmV2ZXJzaWJsZSBpbmhpYml0b3JzCgrihpMgRWZmaWNhY3k6Ci0gQ29tcGV0aXRpdmUgaXJyZXZlcnNpYmxlIGluaGliaXRvcnMKLSBOb24tY29tcGV0aXRpdmUgaW5oaWJpdG9ycw%3D%3D","audio_hint":null,"front":"What is pharmacokinetics?","front_plain":"What is pharmacokinetics?","back":"The effects of the body on the drug (ADME):- Absorption- Distribution- Metabolism- Excretion","back_plain":"The effects of the body on the drug (ADME):\n- Absorption\n- Distribution\n- Metabolism\n- 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toxicity","src":null,"hint":"","hint_plain":"","card_id":18,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=eac895f&s=V2hhdCBpcyBwaGFybWFjb2R5bmFtaWNzPw%3D%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=f80d2ef&s=VGhlIGVmZmVjdHMgb2YgdGhlIGRydWcgb24gdGhlIGJvZHkKLSBJbmNsdWRlcyBjb25jZXB0cyBvZiByZWNlcHRvciBiaW5kaW5nLCBkcnVnIGVmZmljYWN5LCBkcnVnIHBvdGVuY3ksIGFuZCB0b3hpY2l0eQ%3D%3D","audio_hint":null,"front":"Which term encompasses the effects of the body on the drug?","front_plain":"Which term encompasses the effects of the body on the drug?","back":"Pharmacokinetics, eg:- Absorption- Distribution- Metabolism- Excretion","back_plain":"Pharmacokinetics, eg:\n- Absorption\n- Distribution\n- Metabolism\n- Excretion","src":null,"hint":"","hint_plain":"","card_id":19,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=4ab7859&s=V2hpY2ggdGVybSBlbmNvbXBhc3NlcyB0aGUgZWZmZWN0cyBvZiB0aGUgYm9keSBvbiB0aGUgZHJ1Zz8%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=73bf1ac&s=UGhhcm1hY29raW5ldGljcywgZWc6Ci0gQWJzb3JwdGlvbgotIERpc3RyaWJ1dGlvbgotIE1ldGFib2xpc20KLSBFeGNyZXRpb24%3D","audio_hint":null,"front":"Which term encompasses the effects of the drug on the body?","front_plain":"Which term encompasses the effects of the drug on the body?","back":"Pharmacodynamics, eg:- Concepts of receptor binding, drug efficacy, drug potency, and toxicity","back_plain":"Pharmacodynamics, eg:\n- Concepts of receptor binding, drug efficacy, drug potency, and 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What drug\/administration has a bioavailability (F) of 100%?","back":"Fraction of administered drug that reaches the systemic circulation unchangedFor IV dose, F = 100%","back_plain":"Fraction of administered drug that reaches the systemic circulation unchanged\n\nFor IV dose, F = 100%","src":null,"hint":"","hint_plain":"","card_id":22,"srcHint":null,"srcFront":null,"audio_front":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=8852ae1&s=V2hhdCBpcyB0aGUgYmlvYXZhaWxhYmlsaXR5PyBXaGF0IGRydWcvYWRtaW5pc3RyYXRpb24gaGFzIGEgYmlvYXZhaWxhYmlsaXR5IChGKSBvZiAxMDAlPw%3D%3D","audio_back":"https:\/\/tts-cdn.cram.com\/en.mp3?v=1&t=52546d2&s=RnJhY3Rpb24gb2YgYWRtaW5pc3RlcmVkIGRydWcgdGhhdCByZWFjaGVzIHRoZSBzeXN0ZW1pYyBjaXJjdWxhdGlvbiB1bmNoYW5nZWQKCkZvciBJViBkb3NlLCBGID0gMTAwJQ%3D%3D","audio_hint":null,{"front":"What causes decreased bioavailability of orally administered drugs?","front_plain":"What causes decreased bioavailability of orally administered drugs?","back":"F typically
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