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[1,2] [3] [4] In order to more scientifically and more securely formulate the initial dose of the first human clinical trial, more accurately predict and analyze the pharmacokinetics of clinical drugs, and accurately predict the preclinical pharmacokinetic PK Animal models are essential for this
.
[5] [6]
References:
1.
AACR Annual Meeting 2022 | April 8-13, 2022 | New Orleans
2.
Program Guide – ASCO Meeting Program Guide
3.
Publicly soliciting opinions on the “Technical Guidelines for the Clinical Development of Bispecific Antibody Antitumor Drugs” Notice (cde.
org.
cn)
4.
Notice on Publicly Soliciting Comments on the Technical Guidelines for Nonclinical Research of Antibody Conjugates (Draft for Comment) (cde.
org.
cn)
5.
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic | FDA
6.
Valente D, Mauriac C, Schmidt T, et al.
Pharmacokinetics of novel Fc-engineered monoclonal and multispecific antibodies in cynomolgus monkeys and humanized FcRn transgenic mouse models[C]//MAbs.
Taylor & Francis, 2020, 12(1): 1829337.
.
[5] [6]
References:
1.
AACR Annual Meeting 2022 | April 8-13, 2022 | New Orleans
2.
Program Guide – ASCO Meeting Program Guide
3.
Publicly soliciting opinions on the “Technical Guidelines for the Clinical Development of Bispecific Antibody Antitumor Drugs” Notice (cde.
org.
cn)
4.
Notice on Publicly Soliciting Comments on the Technical Guidelines for Nonclinical Research of Antibody Conjugates (Draft for Comment) (cde.
org.
cn)
5.
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic | FDA
6.
Valente D, Mauriac C, Schmidt T, et al.
Pharmacokinetics of novel Fc-engineered monoclonal and multispecific antibodies in cynomolgus monkeys and humanized FcRn transgenic mouse models[C]//MAbs.
Taylor & Francis, 2020, 12(1): 1829337.
