Occurrence of pharmaceutical metabolites and transformation products in the aquatic environment of the Mediterranean area

Occurrence of pharmaceutical metabolites and transformation products in the aquatic environment of the Mediterranean area

Publication: Trends Analyt Chem
Software: ADMET Predictor®

The presence of pharmaceutically active substances (PhACs) in aquatic ecosystems is of great concern due to their constant occurrence in different water systems and potential negative effects on the quality of water...

Dosage Adjustment for Ceftazidime in Pediatric Patients With Renal Impairment Using Physiologically Based Pharmacokinetic Modeling

Dosage Adjustment for Ceftazidime in Pediatric Patients With Renal Impairment Using Physiologically Based Pharmacokinetic Modeling

Publication: J Pharm Sci
Software: GastroPlus®

Physiologically based pharmacokinetic (PBPK) modeling has unique advantages in investigating the pharmacokinetics of drugs in special populations.

Development of PBPK/PD Model to Predict Impact of Genetic Polymorphisms on thePharmacokinetics and Pharmacodynamicsrepresented by receptor/transporter occupancyof CNS drugs

Development of PBPK/PD Model to Predict Impact of Genetic Polymorphisms on thePharmacokinetics and Pharmacodynamicsrepresented by receptor/transporter occupancyof CNS drugs

Publication: Univ. Louisiana Monroe, School of Pharmacy

The general workflow of PBPK modeling and simulation of test compounds in normalpatients and patients with genetic variations consisted of the following steps (see Fig. 1)

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Publication: Bioanalysis

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide.