studies (CXA-101-01 and CXA-101-02) which investigated the PK of ceftolozane as a single entity. There did not appear to be any PK interaction between ceftolozane and tazobactam on the basis of the studies presented. Thus the PK of ceftolozane can be inferred from the combination PK studies presented and a more thorough investigated of the PK of ceftolozane may not be required. This would appear to be in agreement with the relevant guideline. One of the active substances is a new chemical substance. This case should be treated as a New Drug Application and the full characterisation of the pharmacokinetic profile (including is recommended to be made interaction studies and studies in special populations and patients) using the combination (and not only with just the new mono-component). Pharmacodynamics Studies providing pharmacodynamic data Table 2 shows the studies relating to each pharmacodynamic topic and the location of each study summary. 2: Submitted pharmacodynamic studies. PD Topic Subtopic Study ID Primary Effect on clinical and microbiological response CUBI-RAS-008 Pharmacology Secondary Effect on QTc Interval CXA-QT-10-02 Pharmacology Gender other Effect of gender Not conducted genetic and Differences Effect of age Not conducted in PD Response PD Interactions Not conducted Population PD and Healthy subjects CXA-101-PH-003 PK-PD analyses Target population CXA-101-PH-003 CUBI-RAS-003 ICPD ICPD 00319-2 * Indicates the primary aim of the study. § Subjects who would be eligible to receive the drug if approved for the proposed indication. And adolescents if applicable. ‡ None of the pharmacodynamic studies had deficiencies that excluded their results from consideration. Summary of pharmacodynamics The information in the following summary is derived from conventional pharmacodynamic studies in humans unless otherwise stated.
studies (CXA-101-01 and CXA-101-02) which investigated the PK of ceftolozane as a single entity. There did not appear to be any PK interaction between ceftolozane and tazobactam on the basis of the studies presented. Thus the PK of ceftolozane can be inferred from the combination PK studies presented and a more thorough investigated of the PK of ceftolozane may not be required. This would appear to be in agreement with the relevant guideline. One of the active substances is a new chemical substance. This case should be treated as a New Drug Application and the full characterisation of the pharmacokinetic profile (including interaction studies and studies in special populations and patients) is recommended to be made using the combination (and not only with just the new mono-component). Pharmacodynamics Studies providing pharmacodynamic data Table 2 shows the studies relating to each pharmacodynamic topic and the location of each study summary. 2: Submitted pharmacodynamic studies. PD Topic Subtopic Study ID Primary Pharmacology Effect on clinical and microbiological response CUBI-RAS-008 Secondary Pharmacology Effect on QTc Interval CXA-QT-10-02 Gender other genetic and Differences in PD Response Effect of gender Not conducted Effect of age Not conducted PD Interactions Not conducted Population PD and PK-PD analyses Healthy subjects CXA-101-PH-003 Target population CXA-101-PH-003 CUBI-RAS-003 ICPD ICPD 00319-2 * Indicates the primary aim of the study. § Subjects who would be eligible to receive the drug if approved for the proposed indication. ‡ And adolescents if applicable. None of the pharmacodynamic studies had deficiencies that excluded their results from consideration. Summary of pharmacodynamics The information in the following summary is derived from conventional pharmacodynamic studies in humans unless otherwise stated.
auspar-ceftolozane-as-sulfate-tazobactam-as-sodium-salt-160127-cer.docx