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

Phase I blog

07 Mar 2019

There are many studies which could be included in Phase-1 studies. Amongst all those studies First In Man are the most important study as it is for the first time a new drug is being administered in the Human beings. It provides an idea about the Maximum tolerated Dose. The study is by and large conducted in the Healthy male subjects as a cohort of 6 to 8 subjects. There could be 4 to 6 cohorts in the study. Each cohort receives a Dose of the New Drug in the Ascending fashion, hence it is also called Single Ascending Dose study. In each cohort there could be a some subjects receiving active drug and very few receive placebo.

The PK samples are collected at various time intervals to understand the PK profile of the NCE. The results of it will help in designing the next step- MAD ( Multiple Ascending Dose) study.
Invariably the Biomarkers are also used to understand the profile of the drug and to evaluate the safety. It has to be conducted in a special unit with Cardiac monitors with Central monitoring facility, Holter Monitors, Telemetry, etc.

Lambda has a specially designed Phase-1 unit where such studies are conducted.

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