HITISHA SOLANKI

Detail-oriented PharmD candidate with clinical and regulatory experience, specializing in medical affairs, clinical research, and regulatory compliance. Proven expertise in medication therapy management, literature evaluation, scientific communication, and regulatory submissions (Health Canada NPN). Skilled in collaborating cross-functionally to interpret clinical data, develop evidence-based clinical guidelines, and ensure adherence to regulatory standards. Technically proficient with pharmacy information systems, electronic health records (EHR), and clinical data analysis tools. Passionate about driving patient-centric outcomes through evidence generation, pharmacovigilance, and continuous quality improvement initiatives. Fluent in English, Gujarati, and Hindi.

• Conducted noncompartmental pharmacokinetic analyses and effectively managing data complexities like missed sampling times and concentrations below quantitation limits.
• Designed bioequivalence trials using parallel, crossover, and semi-replicate methodologies, aligning study designs with regulatory standards.
• Performed statistical analyses on bioequivalence trial data utilizing SAS® (PROC GLM, PROC MIXED), MS Excel, and R-project, including determining sample size, calculating confidence intervals, and employing advanced modeling techniques such as bootstrapping.
• Gained comprehensive knowledge of bioequivalence regulatory guidelines in Canada, the U.S., and Europe, including practical experience preparing clinical trial protocols, reporting adverse events, and maintaining ethical compliance.
• Developed familiarity with Good Manufacturing Practices (GMP), pharmaceutical quality standards, and procedures for regulatory submissions to ensure compliance with Health Canada requirements.

• Studied biochemical and molecular mechanisms underlying drug-induced toxicities, focusing on reactive oxygen species (ROS) generation and associated drug-induced organ injury.
• Conducted clinical risk assessments, gaining experience in the interpretation of diagnostic laboratory tests to detect and manage hepatic, renal, and cardiac toxicities.

• Developed practical skills in pharmaceutical compounding, including formulation and quality assurance of dosage forms such as tablets, creams, ointments, suppositories, and suspensions.
• Acquired knowledge of specialized pharmaceutical manufacturing processes and quality control procedures for biopharmaceuticals, vaccines, nanomedicines, and radiopharmaceuticals.
• Integrated principles of clinical laboratory medicine into therapeutic drug monitoring and personalized patient care, with a focus on interpreting laboratory results relevant to oncology and metabolic diseases.

• Acquired proficiency in various research methodologies, specifically experimental and non-experimental designs with a strong emphasis on randomized controlled trials (RCTs).
• Applied critical appraisal skills to evaluate clinical research literature for validity, reliability, biases, statistical significance, and accurate interpretation of statistical outcomes such as p-values and confidence intervals.
• Enhanced scientific communication skills through effective presentation and interpretation of research findings, with attention to identifying and mitigating potential publication biases.

• Injection Certified, University of Toronto, 02/01/23
• Level C-CPR (AED included) and Standard First Aid, Canadian Red Cross, 06/01/21 - 06/01/24
• "Stop the Bleed" Massive Bleeding Management, Sunnybrook Health Sciences Centre, 03/01/19
• Infection Control and Prevention, Toronto General Hospital, 01/01/19