It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China



Home / Blog

Overcoming Challenges in a Bioequivalence Assessment Study of Octreotide Acetate Injection

29 Aug 2023

Study Overview

The study aimed to compare the bioavailability and characterize the pharmacokinetic profile of Octreotide Acetate Microspheres for intramuscular Injection (30 mg), with the reference product. An open-label, balanced, randomized, two-treatment, single-period, parallel, single-dose bioequivalence study was carried out by Lambda in normal healthy adult male subjects under fasting conditions. The study was sponsored by a prominent pharmaceutical company in China and intended for submission to the US FDA, adhering to the necessary standards.

Challenges Solutions
Long-duration study having multiple ambulatory visits for post dose PK sampling lasting spanning nearly 6 months. The extensive experience in conducting studies of extended duration played a pivotal role in substantially reducing incidents of subject non-reporting. This was achieved through diligent adherence to timely follow-ups and effective communication strategies with the study participants, resulting in heightened compliance levels.
High sample size A qualified, trained, and highly experienced study team was employed to handle all logistics with precision, ensuring consistent on-time execution of study-related activities. This approach guaranteed strict adherence to timelines and efficient management of tasks, particularly in relation to the timely collection of samples.
Subject recruitment Utilized a substantial volunteer database and a dedicated team of experienced subject recruiters to efficiently address subject recruitment challenges.
Additional safety tests in screening i.e. USG abdomen, TFT, S. Amylase, S. Lipase, S. ALP. Utilized an in-house Central Lab with capabilities for real-time processing of safety samples, enabling quick generation and release of safety reports, thus ensuring swift screening of eligible subjects with minimal Turn Around Time.
Number of expected AEs and SAEs 24/7 Medical Oversight: Implemented round-the-clock availability of Study Physicians during housing and ambulatory visits to handle any unexpected Adverse Events or Serious AEs, closely monitored by the Principal Investigator.


  • Enrolled approximately 250 healthy male volunteers based on stringent selection criteria, aligning with the study protocol, involving multiple ambulatory sample visits.
  • Demonstrated expertise in managing stratified (Based on subjects' body weight) randomization during subject enrolment.
  • Effectively addressed clinical conduction challenges by implementing meticulous micro-level manpower management strategies to handle multiple study groups simultaneously.

Leverage Lambda & Novum's extensive experience & proven track record to accelerate your clinical research. Get in touch with our team of experts.

Looking for a Globally Proven Research Partner?

Contact Us