Log In Sign up
The largest database of trusted experimental protocols

Phoenix winnonlin build 8

Manufactured by Certara
Visit Supplier

Phoenix WinNonlin Build 8 is a software application designed for pharmacokinetic and pharmacodynamic data analysis. It provides a comprehensive suite of tools for modeling, simulation, and reporting of drug and biomarker data.

Automatically generated - may contain errors

Lab products found in correlation

Close spelling variants of this product

Phoenix WinNonlin 8.1 Phoenix WinNonlin WinNonlin 8.0 Phoenix 8.1 WinNonlin

5 protocols using phoenix winnonlin build 8

1

Pharmacokinetic and Virologic Outcomes of Bictegravir-Containing ART

Cited 2 times
Check if the same lab product or an alternative is used in the 5 most similar protocols
Pharmacokinetic parameters were estimated by performing a non-compartmental analysis (NCA) using Phoenix WinNonlin Build 8 (Certara), using all PK data available starting with the time point after the last infusion of 10–1074 from either TZM-bl assay (using the X2088_c9 pseudovirus to determine 10–1074 levels) or ELISA, and compared by a two-tailed unpaired t-test. CD4+ T cell counts on day 0 and at the time of viral rebound were compared by two-tailed paired t-test. IUPM determined at week −2 and week 12 compared using a two-tailed paired t-test. Time to rebound in current trial participants (combination therapy with 3BNC117 + 10–1074), participants receiving 3BNC117 monotherapy9 (link) and participants in previous non-interventional ATI studies conducted by ACTG10 (link) were plotted using Kaplan-Meier survival curves. Potential correlation between IUPM and time to rebound was analyzed by two-tailed Pearson correlation test.
Mendoza P., Gruell H., Nogueira L., Pai J.A., Butler A.L., Millard K., Lehmann C., Suárez I., Oliveira T.Y., Lorenzi J.C., Cohen Y.Z., Wyen C., Kümmerle T., Karagounis T., Lu C.L., Handl L., Unson-O’Brien C., Patel R., Ruping C., Schlotz M., Witmer-Pack M., Shimeliovich I., Kremer G., Thomas E., Seaton K.E., Horowitz J., West AP J.r., Bjorkman P.J., Tomaras G.D., Gulick R.M., Pfeifer N., Fätkenheuer G., Seaman M.S., Klein F., Caskey M, & Nussenzweig M.C. (2018). Combination therapy with anti-HIV-1 antibodies maintains viral suppression. Nature, 561(7724), 479-484.
+ Open protocol
+ Expand
2

Serum 3BNC117 Quantification Protocol

Cited 1 time
Check if the same lab product or an alternative is used in the 5 most similar protocols
Serum concentrations of 3BNC117 were measured at multiple time points postinfusion using a validated luciferase-based neutralization assay in TZM.bl cells as previously described (Sarzotti-Kelsoe et al., 2014 (link)). Briefly, serum samples were tested using a primary 1:20 dilution with fivefold titration series against HIV-1 Env pseudovirus Q769.d22, which is highly sensitive to neutralization by 3BNC117. Env pseudoviruses were produced using an ART-resistant backbone vector that reduces background inhibitory activity of antiretroviral drugs if present in the serum sample (SG3ΔEnv/K101P.Q148H.Y181C, M.S. Seaman, unpublished data). 3BNC117 clinical drug product was also tested in every assay setup using a primary concentration of 10 µg/ml with fivefold titration series. The serum concentration of 3BNC117 for each sample was calculated as follows: serum ID50 titer (dilution) × 3BNC117 IC50 titer (μg/ml) = serum concentration of 3BNC117 (μg/ml). Murine leukemia virus was used as a negative control. All assays were performed in a laboratory meeting GCLP standards. The half-life of 3BNC117 was calculated using Phoenix WinNonLin Build 8 (Certara).
Cohen Y.Z., Lorenzi J.C., Krassnig L., Barton J.P., Burke L., Pai J., Lu C.L., Mendoza P., Oliveira T.Y., Sleckman C., Millard K., Butler A.L., Dizon J.P., Belblidia S.A., Witmer-Pack M., Shimeliovich I., Gulick R.M., Seaman M.S., Jankovic M., Caskey M, & Nussenzweig M.C. (2018). Relationship between latent and rebound viruses in a clinical trial of anti–HIV-1 antibody 3BNC117. The Journal of Experimental Medicine, 215(9), 2311-2324.
+ Open protocol
+ Expand
3

Pharmacokinetics and Viral Rebound Analysis

Cited 2 times
Check if the same lab product or an alternative is used in the 5 most similar protocols
Pharmacokinetic parameters were estimated by performing a non-compartmental analysis (NCA) using Phoenix WinNonlin Build 8 (Certara), using all PK data available starting with the time point after the last infusion of 10-1074 from either TZM-bl assay (using the X2088_c9 pseudovirus to determine 10-1074 levels) or ELISA, and compared by a two-tailed unpaired t-test. CD4+ T cell counts on day 0 and at the time of viral rebound were compared by two-tailed paired t-test. IUPM determined at week -2 and week 12 compared using a two-tailed paired t-test. Time to rebound in current trial participants (combination therapy with 3BNC117 + 10-1074), participants receiving 3BNC117 monotherapy9 (link) and participants in previous non-interventional ATI studies conducted by ACTG10 (link) were plotted using Kaplan-Meier survival curves. Potential correlation between IUPM and time to rebound was analyzed by two-tailed Pearson correlation test.
Mendoza P., Gruell H., Nogueira L., Pai J.A., Butler A.L., Millard K., Lehmann C., Suárez I., Oliveira T.Y., Lorenzi J.C., Cohen Y.Z., Wyen C., Kümmerle T., Karagounis T., Lu C.L., Handl L., Unson-O’Brien C., Patel R., Ruping C., Schlotz M., Witmer-Pack M., Shimeliovich I., Kremer G., Thomas E., Seaton K.E., Horowitz J., West AP J.r., Bjorkman P.J., Tomaras G.D., Gulick R.M., Pfeifer N., Fätkenheuer G., Seaman M.S., Klein F., Caskey M, & Nussenzweig M.C. (2018). Combination therapy with anti-HIV-1 antibodies maintains viral suppression. Nature, 561(7724), 479-484.
+ Open protocol
+ Expand
4

Antibody Sensitivity Assay and Pharmacokinetics

Cited 1 time
Check if the same lab product or an alternative is used in the 5 most similar protocols
Supernatants from p24-positive bulk CD4+ T cell cultures and pseudoviruses were tested for sensitivity to antibodies as previously described16 (link).
Pharmacokinetic analyses. PK-parameters were estimated by performing a non-compartmental analysis (NCA) using Phoenix WinNonlin Build 8 (Certara), using all PK data available starting with the time point after the infusion of 3BNC117 from either TZM-bl assay or ELISA.
Bar-On Y., Gruell H., Schoofs T., Pai J.A., Nogueira L., Butler A.L., Millard K., Lehmann C., Suárez I., Oliveira T.Y., Karagounis T., Cohen Y.Z., Wyen C., Scholten S., Handl L., Belblidia S., Dizon J.P., Vehreschild J.J., Witmer-Pack M., Shimeliovich I., Jain K., Fiddike K., Seaton K.E., Yates N.L., Horowitz J., Gulick R.M., Pfeifer N., Tomaras G.D., Seaman M.S., Fätkenheuer G., Caskey M., Klein F, & Nussenzweig M.C. (2018). Safety and anti-viral activity of combination HIV-1 broadly neutralizing antibodies in viremic individuals. Nature medicine, 24(11), 1701-1707.
+ Open protocol
+ Expand
5

Non-Compartmental PK Analysis

Check if the same lab product or an alternative is used in the 5 most similar protocols
PK-parameters were estimated by performing a non-compartmental analysis (NCA) using Phoenix WinNonlin Build 8 (Certara), using all PK data available starting with the time point after the infusion of 3BNC117 from either TZM-bl assay or ELISA.
Bar-On Y., Gruell H., Schoofs T., Pai J.A., Nogueira L., Butler A.L., Millard K., Lehmann C., Suárez I., Oliveira T.Y., Karagounis T., Cohen Y.Z., Wyen C., Scholten S., Handl L., Belblidia S., Dizon J.P., Vehreschild J.J., Witmer-Pack M., Shimeliovich I., Jain K., Fiddike K., Seaton K.E., Yates N.L., Horowitz J., Gulick R.M., Pfeifer N., Tomaras G.D., Seaman M.S., Fätkenheuer G., Caskey M., Klein F, & Nussenzweig M.C. (2018). Safety and anti-viral activity of combination HIV-1 broadly neutralizing antibodies in viremic individuals. Nature medicine, 24(11), 1701-1707.
+ Open protocol
+ Expand

About PubCompare

Our mission is to provide scientists with the largest repository of trustworthy protocols and intelligent analytical tools, thereby offering them extensive information to design robust protocols aimed at minimizing the risk of failures.

We believe that the most crucial aspect is to grant scientists access to a wide range of reliable sources and new useful tools that surpass human capabilities.

However, we trust in allowing scientists to determine how to construct their own protocols based on this information, as they are the experts in their field.

Ready to get started?

Sign up for free.
Registration takes 20 seconds.
Available from any computer
No download required

Sign up now

Revolutionizing how scientists
search and build protocols!