Blog

How can precision dosing be integrated into model-informed drug development Integrating precision dosing into model-informed drug development (MIDD) is an innovative approach that enhances the efficiency and ...

PopPK Modeling of Rivoceranib in Healthy Subjects and Cancer Patients This poster focuses on the pharmacokinetic study of rivoceranib in healthy subjects and patients with various cancers.

PopPK and PD Modeling of NGM707, an ILT2/ILT4 Dual Antagonist Antibody in Patients with Advanced or Metastatic Solid Tumors PK of NGM707 were typical for therapeutic monoclonal antibodies. Only body weight was identified as a relevant PK covariate. Age, sex, ...

Food and Co-administration of Acid Reducing Agents (ARAs) Have No Clinically Significant Effect on the Pharmacokinetics of Etrumadenant, a Novel Dual Adenosine Receptor Antagonist Etrumadenant (etruma), is an orally bioavailable, selective, A2a and A2b receptor antagonist that has demonstrated safety and clinical ...

Population Pharmacokinetic Modeling of Camrelizumab in Patients with Various Cancer Types, Including Advanced Hepatocellular Carcinoma Camrelizumab is a humanized monoclonal antibody (mAb) that specifically binds to programmed cell death receptor 1 (PD-1), being developed ...

PopPK Modeling of NGM438 in Advanced/Metastatic Solid Tumor Patients PK of NGM438 was typical for therapeutic monoclonal antibodies. Besides body weight, only baseline albumin level was identified as a ...

Clinical Pharmacology Considerations for ADC Guidance for Industry This guidance issued on March 2024 provides recommendations to assist industry and other parties involved in the development of ADCs. ...

Pediatric Dose Simulations Applying popPK & exposure-response models to limited access populations provides improved drug development outcomes for patients & ...

Novel ADC PK Assays Revolutionize Targeted Therapy Analysis The collaborative effort by the Amador Bioanalysis & Biomarkers team shed light on efficient and robust methods of generating accurate ...

Evaluating ADA Response Essential for Biologics The FDA and other world health authorities recommend pharmaceutical companies investigate the immune response to biologics, given that the ...

Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis Another paper from our biomarker and bioanalysis team for you this week!

Remote audits: a CRO virtual reality-what lessons have been learned in a time of unexpected isolation This week we're highlighting the work Rafiq Islam, VP of Bioanalysis & Biomarkers at Amador Bioscience, and a team of highly ...

【Webinar】 Quantitative Bio-analysis of ADCs using Mass Spectrometry (with video) Join this webinar to gain insights into developing and validating LC-MS PK assays for antibody-drug conjugates and their role in advising ...

Combination therapies and predicting regimens Quantitative systems pharmacology (QSP) modeling uses already available clinical trial data to evaluate novel therapeutic regimens prior to ...

Where Science Meets Strategy: Elevate Your Drug Development Program with Clinical Pharmacology Developing dosing strategies for drug candidates involves a multidisciplinary approach that combines pharmacology, clinical expertise, data ...

Differences in levels ofphosphatidylinositols in healthy and stable Coronary Artery Disease subjects revealed by HILIC-MRM method with SERRF normalization Today's mid-week read is a Public Library of Science (PLOS) publication from Dr. Meina Liang, our Chief Technology Officer (CTO) and ...

Assay validation and clinical performance of chronic inflammatory and chemokine biomarkers of NASH fibrosis It's time for this week's read! This week we are featuring an PLOS paper by Rafiq Islam, VP of Bioanalysis and Biomarkers at Amador ...

【Webinar】 Model Informed Drug Development: Application to Project Optimus (with video) Watch this webinar to gain insights into how to use model informed drug development in oncology to support dose selection in agreement with ...

Project Optimus: Drug Development Expertise Fits New FDA Guidance Targeting Cancer Therapeutics Learn how to meet the requirements in the new FDA guidance targeting Project Optimus and optimizing dosing and selection of targeted cancer ...

【Webinar】 Bioanalytical Strategies for Gene Therapy: Bioanalysis of Lipid Nanoparticles Encapsulated Antisense Oligonucleotides (with video) Bioanalysis is the foundation of novel drug development. Although regulatory guidance exists for manufacturing, non-clinical and clinical ...

Pharmacokinetics of Hydrochlorothiazide in Children: A Potential Surrogate for Renal Secretion Maturation Your read this week comes from Dr. Huali Wu, Director of Pharmacometrics at Amador and the American College of Clinical Pharmacy (ACCP).

Viral kinetics in CoVlD-19outpatients treated with CASIRIVIMAB plus IMDEVIMAB combination This week's Monday read is from Topics in Antiviral Medicine and Dr. Nidal Huniti, President of Clinical Pharmacology at Amador.

Pharmacokinetics of Hydrochlorothiazide in Children: A Potential Surrogate for Renal Secretion Maturation Your Wednesday read this week comes from Dr. Huali Wu, Director of Pharmacometrics at Amador and the American College of Clinical Pharmacy ...

Estimation of Body Fat Percentagefor Clinical Pharmacokinetic Studies in Children Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children

Monoclonal Antibody Treatment,Prophylaxis and Vaccines Combined to Reduce SARS CoV-2Spread Monoclonal Antibody Treatment,Prophylaxis and Vaccines Combined to Reduce SARS CoV-2Spread

High-sensitivity quantification ofantisense oligonucleotides forpharmacokinetic characterization High-sensitivity quantification ofantisense oligonucleotides forpharmacokinetic characterization