Syngene’s in-house Human Pharmacology Unit (HPU) offers full-service solutions for phase-1/ safety/ bioavailability (BA) and bioequivalence (BE) studies.
Syngene has almost two decades of experience in conducting phase I/ first-in-human studies (FIH), drug-drug interaction (DDI) studies, proof-of-concept (POC) studies, bioavailability (BA)/ bioequivalence (BE) studies, and pharmacokinetic (PK)/ pharmacodynamic (PD) studies.
We have several years of experience in conducting studies for submission to the US food and drug administration (FDA), Brazil’s national health surveillance agency (ANVISA), the European Medicines Agency (EMA), and other major drug regulatory authorities. We follow well-established project management systems and offer tailor-made project plans to meet unique study requirements.
View our capability deck on Clinical Pharmacology studies
Syngene has experience in conducting single ascending dose (SAD), multiple ascending dose (MAD), drug-drug interaction (DDI), and food-effect studies of new chemical entities (NCEs)/ new biological entities (NBEs). We also have extensive experience in conducting phase-1 trials of biosimilars and vaccines meant for regulated and ROW markets.
Bioavailability/ Bioequivalence studies
Syngene conducts BA/ BE studies for submission in regulated markets such as the European Union, United Kingdom, United States of America, Canada, Brazil, and Australia. We have conducted more than 700 BA/BE studies to support several abbreviated new drug applications (ANDA) for clients globally. We have extensive experience in conducting BA/BE studies on healthy volunteers, special populations (i.e., postmenopausal women), and various dosage forms such as tablets, capsules, nasal formulations, topicals, suppositories, and parenteral formulations.
Our in-house bioanalytical lab has developed and validated more than 230 bioanalytical methods in compliance with current international regulatory requirements and guidance. Our bio-analytical laboratory in the HPU is equipped with cutting-edge, highly sophisticated mass spectrometers such as API 4000 and API 6500. We have implemented Watson laboratory information management system (LIMS) software in our laboratory. All our computer systems are validated as per the code of federal regulations (CFR) 21 Part 11.
View our list of validated assays for BA/BE Studies
Our human pharmacology unit (HPU), established in 2004, has state-of-the-art infrastructure spread over 37,500 square feet with an in-house bioanalytical lab and a bed capacity of 190. Our HPU is equipped with a 12-bed intensive care unit (ICU) unit and dedicated staff trained in advanced cardiovascular life support (ACLS) and basic life support (BLS).
We have a fully equipped ambulance on standby at all times to shift study subjects. We have a contract with a tertiary care hospital three kilometers away to handle medical emergencies. We use an in-house clinical lab for volunteer screening and safety evaluations. This helps reduce turn-around time in decision-making.
The ICU unit has advanced instruments such as emergency crash carts, telemetry, suction pumps, infusions pumps, oxygen cylinders, defibrillators, Ambu bags, resuscitation kits, and Infusomat pumps. The unit also includes an electrocardiogram (ECG) machine, YSI glucose analyzer, nebulizer, SureTemp Plus thermometers, pulse oximeter, and emergency medicines.
The pharmacy in HPU is equipped with a laminar airflow refrigerator maintained at a constant temperature of 40°C, a weighing balance, a mechanical shaker, monochromatic light, and a synchronized clock. The unit’s computer system can be accessed only by authorized personnel such as the pharmacist and maintenance teams. Our pharmacy includes a temperature/ humidity chamber that relies on a specialized software-based data logger to maintain the temperature and humidity within. The pharmacy is closely monitored through CCTV cameras placed throughout the facility.
HPU team comprises experienced investigators, project managers, duty doctors, quality control personnel, pharmacists, dieticians, custodians, counselors, nurses, laboratory technologists, phlebotomists, volunteer coordinators, and non-technical staff.
Our HPU has been audited by the US FDA, ANVISA, and EMA. Additionally, our central laboratory is accredited by the College of American Pathologists (CAP).