Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
kg, kg · 1 trial · 2 indications
Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.
Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
| Arm | Type | Description |
|---|---|---|
| PF-04950615 (RN316) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 4 mg/kg | BIOLOGICAL | RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes. |
| 0.5 mg/kg | BIOLOGICAL | RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes. |
Inclusion Criteria: * On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1. * BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg. Exclusion Criteria: * History of a cardiovascular event (e.g., MI ) during the past year. * Poorly controlled Type 1 or Typ...
1 mg, 5 mg, 10 mg is an investigational drug being developed by Pfizer, Inc. (PFE). It is being studied for use in neoplasms, non-Hodgkin lymphoma, meningococcal vaccine, growth disorder, hypercholesterolemia, and non-squamous lung cancer. The drug is currently in Phase 1 clinical development.
1 mg, 5 mg, 10 mg is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for multiple indications including neoplasms and growth disorder.
1 mg, 5 mg, 10 mg is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for conditions such as neoplasms, non-Hodgkin lymphoma, and growth disorder.
1 mg, 5 mg, 10 mg has been studied in clinical trials including NCT00037791 and NCT00039910, which evaluated its safety and efficacy in preventing thrombocytopenia in patients with neoplasms and lymphoma. These trials were Phase 3 and have been completed.
1 mg, 5 mg, 10 mg is associated with the investigational drug PN-152,243, also referred to as PN-196,444. Clinical trials such as NCT00037791 and NCT00039910 studied the safety and efficacy of PN-152,243/PN-196,444 in preventing thrombocytopenia.