Human Pharmacology Studies
Syngene’s Human Pharmacology Unit (HPU) has state of the art infrastructure spread over 37,500 sq. ft. with 190 beds. This unit, with a captive Bioanalytical Lab, offers full service solutions for PK/BE studies. Our HPU has been audited by the US-FDA, ANVISA (Brazil) and EMA. It has also received approvals from the Ministries of Health of UAE and Malaysia.
Our HPU has a fully equipped 12-bed ICU and has contract with a tertiary care hospital (located within 3 KM) for handling medical emergencies. HPU uses in-house clinical lab for volunteer screening and safety evaluations, thus reducing the turn-around time. With a team of qualified, trained and experienced clinical research professionals, Syngene’s HPU conducts Phase I and BA/BE studies with a strong commitment to quality.
The HPU has a dedicated QC team to ensure that all studies are conducted in compliance with protocol, Standard Operating Procedures (SOPs) and applicable guidelines and regulations. In addition, Syngene’s Quality Assurance team independently monitors the quality of all the deliverables. These studies are conducted in accordance with national and international Good Clinical Practice (GCP) guidelines and regulatory requirements.
Our early phase clinical development services include:
- Bioavailability/bioequivalence studies
- Pharmacokinetic/pharmacodynamic studies
- Phase I / First-in-human studies
- Drug-drug-interaction studies
- Proof-of-concept studies
Bioavailability (BA)/ Bioequivalence (BE) studies:
Syngene is highly reputed and experienced in conducting BA/BE studies for submissions in regulated markets such as EU, UK, USA, Canada,Brazil and Australia. Bioequivalence studies are conducted as part of data that goes into marketing authorization applications of generic drugs. Syngene has conducted over 450 Bioequivalence studies to support several ANDAs of clients from across the globe.
Syngene has experience of conducting BE studies on various dosage forms, including Tablets, capsules, ER, nasal formulations, topicals, suppositories and parenterals.
Our bio-analytical laboratory is equipped with cutting edge, highly sophisticated mass spectrometers (API 4000 & API 6500). We have developed and validated over 150 bio-analytical methods. All analytical methods are validated in compliance with current international regulatory requirements or guidance. Our bio-analytical laboratory has implemented Watson LIMS, and all computer systems are validated as per CFR 21 Part 11. All data is electronically transferred and documented and all studies are scrutinized by the QA Department and subjected to periodic in-house audits to ensure compliance.
Advantages
Partnering with Syngene’s HPU for clinical development services offers the following advantages:
- Extensive experience in conducting Phase I and BA/BE studies in healthy volunteers and special populations.
- Well established project management systems and several years of experience in working with overseas sponsors.
- Experienced team for coordinating and obtaining regulatory approvals/licenses from local regulatory agencies.
- State-of the-art infrastructure, FDA and EMA audited clinics and bio analytical labs, and CAP accredited Central Laboratory.
- Flexible pricing model by offering services on standalone basis and also as a full service suite.
