Pavani Gonnabathula
Independent Consultant Pharmacology and Toxicology @Multiple Companies
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WORK HISTORY
Independent Consultant Pharmacology and Toxicology @Multiple Companies
As an independent consultant in toxicology and clinical pharmacology, where I supported evidence-based decision-making throughout product development and safety evaluation. •Applied toxicokinetics, PK/PD, and PBPK modeling in conjunction with regulatory-focused scientific reviews to translate complex data into clear, defensible conclusions. •Collaborated with cross-functional teams on chemical and drug risk assessments, developed safety frameworks for infant and pediatric products, and conducted evaluations for special populations, including those in pregnancy. •Delivered practical, regulatory-aligned outputs that strengthened safety strategies, improved confidence in dosing and exposure decisions, and contributed positively to public health impact. •Provided domain expertise in the development of outcome-verifiable evaluation datasets and long-horizon reasoning tasks for life-science LLMs. •Utilized PBPK/IVIVE and PK/PD expertise to benchmark AI models against real drug discovery and development decisions, such as dose selection, DDI reasoning, safety interpretation, and assessments for special populations. •Developed structured rubrics, conducted expert reviews, and performed error analyses to enhance the reliability and performance of life-science AI models.
EDUCATION
State Board of Technical Education and Training
Government Polytechnic For Women-KAKINADA, Diploma In Pharmacy, Pharmaceutical Sciences
ZPH School - GAVARAVARAM- VISAKHAPATNAM
SSC, High School/Secondary Diplomas and Certificates
University of Arkansas for Medical Sciences
Graduate Certificate, Regulatory Sciences
Kakatiya University, Warangal
Master of pharmacy, Industrial Phamacy
Vignana Jyothi Jr College
Intermediate, Biology, General
Andhra University
Maharajah's college of pharmacy, Bachelor of Pharmacy (BPharm), Pharmaceutical Sciences
Texas Southern University
Doctor of Philosophy - PhD, Environmental Toxicology
ABOUT PAVANI GONNABATHULA
Clinical Pharmacology | Toxicology | PBPK/PBTK | PopPK | PK/PD | Model-Informed Drug Development | Environmental Risk Assessment Modeling & Simulation:PBPK | PBTK | Population Pharmacokinetics (PopPK)| PK/PD Modeling | Antimicrobial PK/PD | Pediatric and Pregnancy Modeling | Special Populations Modeling | Mechanistic Modeling | Sensitivity Analysis | DDI Modeling | Renal Impairment Modeling | Human PK Extrapolation from Preclinical Data | Allometry | Mathematical Modeling Modeling Platforms, Software & Programming:Simcyp | GastroPlus | PK-Sim | MonolixSuite | NONMEM | WinNonlin | Phoenix NLME | Berkeley Madonna | R | SAS | GraphPad Prism | PKNCA | nlmixr2 | rxode2 IVIVE / IVIVC / Translational Modeling:IVIVE | Mathematical and Mechanistic IVIVC | Translation of In Vitro, In Vivo, and In Silico Data for Clinical Decision-Making | Extrapolation of Preclinical Models to Human Models | Model-Informed Dose Optimization Pharmaceutical & Clinical PK Expertise:Preclinical and Clinical Pharmacokinetics | IND-Enabling PK Studies | Biopharmaceutics Assessment | Population-Specific Dose Prediction | Clinical Trial Design Support | Regulatory Application of MIDD Toxicology & Risk Assessment:Environmental Toxicology | Chemical Risk Assessment | Public Health-Oriented PBTK Modeling | Benzene | PFAS | Adult and Pediatric Risk Assessment | Acute and Chronic Exposure Modeling In Vitro / Experimental / DMPK Expertise:In Vitro DMPK | Solubility | Protein Binding Assays | Blood-to-Plasma Ratio | Metabolic Stability | CYP Induction Assays | Melanin Binding Assays | LC-MS | UPLC Research & Scientific Skills:Literature Review | Experimental Design (In Vitro and In Vivo)| Scientific Writing | Data Analysis | Statistical Analysis | Data Visualization Regulatory Science & Compliance:FDA/ICH Regulatory Frameworks | GMP | GLP | GCP | Regulatory Science | Risk Assessment | Clinical Trial Management Quantitative Analysis, Statistics & Visualization:R Programming | Statistical Analysis | PK/PD Data Analysis | Data Visualization | GraphPad Prism Professional Background Highlights:Former U.S. FDA and CDC Scientist | Pharmacokinetic Modeling Scientist | Life-Stage PBPK Modeling | COVID-19 Therapeutics Modeling | Environmental Chemical Modeling | Public Health and Drug Development ApplicationsPassionate about:• Advance safe and effective therapies for high-risk populations through MIDD.• Bridge toxicology with clinical pharmacology• Collaborate across industry, academia, and agencies to drive evidence-based, model-informed decisions.
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