Full-service solutions for Phase-1 trials and BA/BE studies
Human pharmacology studies represent the first stage of testing in human participants, ‘first-in-human’ studies. Although the treatment would have been thoroughly tested in the laboratory and through animal studies, side effects in participants cannot be ruled out. Hence, Phase-1 trials, especially of novel drugs, involve significant risks, necessitating the need for due care and compliance.
Syngene’s in-house human pharmacology unit (HPU) offers full-service solutions for the entire gamut of Phase-1 trials, including dose escalation studies, PK/PD studies, food interaction studies, drug-drug interaction studies, etc. We also provide full-service solutions for BA/BE studies to support development programs of generic drugs and novel dosage forms. Being a responsible global organization, we conduct all studies in compliance with regulatory standards.
Our full-service solution includes feasibility assessment, protocol development, ethics committee submissions, liaising with regulatory authorities for approvals, study execution, Central Laboratory support, regulated Bioanalytical Laboratory support, data management, biometrics, and clinical study report (CS) writing. With all capabilities and allied services available under one roof, we offer clients the benefits of time and cost efficiencies.
Key features of Syngene’s Human Pharmacology Unit
- State-of-the-art infrastructure spread across 37,500 square feet, including an in-house bioanalytical lab, a bed capacity of 190, and an intensive care unit of 12 beds
- Two decades of experience in conducting Phase- 1 clinical trial of novel drugs and vaccines, PK/PD equivalence studies of biosimilars, and BA/BE studies of generic drugs or novel dosage forms
- Inspected several times by US food and drug administration (FDA), Brazil’s national health surveillance agency (ANVISA), the European medicines agency (EMA), the medicines and healthcare products regulatory authority (MHRA), US, and other major drug regulatory authorities
- Conducted more than 800 studies, including Phase-1 trials and BA/BE studies to support several new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs)
- Well-established project management group that develops and implements tailor-made project plans to meet the unique requirements of each study.
- Healthy volunteer database of 22,000+ male and female volunteers
- Low drop-out rate of < 5%
View our capability deck on Clinical Pharmacology studies
Phase-1 trials
Phase-1 studies often involve high failure rates due to stringent screening criteria, long housing duration and follow-up timelines for volunteers (hence high dropout rates), high risk of adverse events, and more. Not every clinical research organization (CRO) can manage these risks adequately — unlike Syngene, a global CRO/CRDMO serving the Life Sciences Industry since 1993.
We have a healthy volunteer database of 22,000+ male and female volunteers. To ensure compliance with screening parameters, we have volunteer cross-participation and verification software to identify if volunteers have participated in any studies within the last 90 days. We use a medical plan for handling various dosage forms, and study designs for drug administration and medical management drawn up in consultation with specialists. Our core medical team comprises physicians and intensivists with expertise in patient management and emergency care. Our drop-out rate for Phase -1 trials for biosimilars and vaccines is <2%.
We have experience in conducting the following studies:
- Single ascending doses (SAD)
- Drug-Drug interaction (DDI)
- Food-effect studies on new chemical entities (NCEs)
- Studies on new biological entities (NBEs)
- PK/PD trials on biosimilars and vaccines meant for regulated markets and the rest of the world
Bioavailability/ Bioequivalence studies
Syngene conducts BA/ BE studies for submission in regulated markets such as the European Union, the United Kingdom, the United States of America, Canada, Brazil, and Australia. We have conducted more than 800 BA/BE studies to support several ANDA and 505 (b)(2) applications for clients globally.
We have extensive experience conducting the following studies:
- Single and multiple-dose BA/BE studies in healthy volunteers
- Studies on special populations (i.e., post-menopausal women)
- Across dosage forms i.e., tablets, capsules, nasal formulations, topicals, suppositories, and parenteral formulations
Using our in-house Bioanalytical lab, we have developed and validated more than 240 bioanalytical methods in compliance with current international regulatory requirements and guidance.
Our Bioanalytical laboratory, which supports clinical programs of small molecules and biologics, is equipped with cutting-edge, highly sophisticated mass spectrometers such as API 6500, MSD, Biacore, etc. The laboratory is OECD and GLP-certified and USFDA audited.
We have implemented Watson laboratory information management system (LIMS) software in our laboratory for streamlined data management, operational efficiency, and compliance. 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.
HPU infrastructure
Our human pharmacology unit (HPU) has state-of-the-art infrastructure spread across 37,500 square feet, including an in-house bioanalytical lab. With a bed capacity of 190 and an intensive care unit (ICU) of 12 beds, the HPU is manned by dedicated staff trained in advanced cardiovascular life support (ACLS) and basic life support (BLS). The entire Unit has been audited by the US FDA, ANVISA, MHRA, and EMA, while the Central Laboratory is accredited by the college of American pathologists (CAP) and the national accreditation board for testing and calibration laboratories (NABL), India.
The HPU has a fully equipped ambulance on standby at all times to shift study subjects to a hospital in case of a medical emergency. Syngene has a contract with a tertiary care hospital three kilometers away to address such requirements. For volunteer screening and safety evaluations, we use an in-house clinical lab. The in-house clinical lab helps reduce turn-around time in decision-making.
The ICU unit has advanced instruments such as emergency crash carts, telemetry, suction pumps, infusion pumps, oxygen cylinders, defibrillators, Ambu bags, resuscitation kits, and syringe pumps. The Unit also includes an electrocardiogram (ECG) machine, nebulizer, SureTemp Plus thermometers, pulse oximeter, and emergency medicines.
The pharmacy in the HPU is equipped with laminar airflow, cold rooms(2-8°C) °, a weighing balance, a mechanical shaker, monochromatic light, and a synchronized clock. It includes temperature/ humidity chambers that rely on a specialized software-based data logger to maintain the temperature and humidity. The pharmacy is closely monitored through CCTV cameras placed throughout the facility. The Unit’s computer system is accessible only to authorized personnel such as the pharmacist and maintenance teams.
In terms of staffing, the HPU team comprises experienced investigators, project coordinators, duty doctors, quality control personnel, pharmacists, dietician, custodians, counselors, nurses, laboratory technicians, phlebotomists, volunteer coordinators, and non-technical staff.
