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


08 Apr 2018

Developing and launching a new pharmaceutical drug to the market is an immensely expensive operation. Pharmaceutical scientists and physicians are constantly engaged in research to find the best ways to diagnose and treat disease; with focus on the ‘Risk vs. Benefit ratio'(always trying to see that the amount of benefit clearly outweighs the associated risk). It is a unique challenge as out of every 9,000-10,000 compounds researched, maybe one reaches the market


Though science and technology advances in drug discovery and development have taken a leap, registration of new molecules was on the decline. To overcome this, in 2004, the US Food and Drug Administration (FDA) introduced its ‘Critical Path’ document which showcased examples of how newer methodologies if incorporated early in the drug development process may help in bringing new therapeutic agents to the market. This was also supported by other regulatory agencies like EMEA. Later, in 2006, FDA issued a new Exploratory Investigational New Drug guidance that allowed studies to be conducted at dose levels which do not produce signi?cant clinical toxicity, termed as ‘Phase 0’ (micro-dosing) trials. These studies can be initiated without the detailed preclinical toxicology studies required for Phase 1 studies. Phase 0 trials are aimed to basically understand the pharmacokinetics and pharmacodynamics before ensuing Phase 1 trials.


In a Phase 0 trial, the new viable tool in drug development, the first in man PK studies, a micro-dose of the drug is used. A micro-dose is defined as less than 1/100th of the dose of a test substance calculated (based on animal data) to yield a pharmacologic effect of the test substance with a maximum dose of ≤100 micrograms (source: Guidance for Industry, Investigators, and Reviewers; Exploratory IND Studies; Jan-2006); Initial dose ≤1/50th of the no-observed-adverse-effect level (NOAEL).

Table: Advantages and Disadvantages of Phase 0 trial


Advantages Disadvantages

Adverse events risk is lower as micro-dosing uses minute quantities of the drug

Results may not be indicative of larger doses

First in man study - can indicate appropriate drugs for future development

Minute quantities of drug requires sophisticated tools for assessment

Provide basis for pharmacological dose

Patients may be skeptical for enrolling due to the short period, and as they may have to undergo washout for participating in further studies

May help to arrive at the cost of the drug and help planning for further development



Phase 0 trials must also be considered keeping the patient’s safety in focus as the toxicology data is limited. Patient has to be informed clearly about the lack of therapeutic intent and the investigational nature. The study must be designed from inputs of all stakeholders such as, clinicians, biostatisticians, translational scientists etc.


Phase 0 trials can help in reducing time and costs, at the same time helping to plan better subsequent phase trials




1) US Department of Health and Human Services, Food and Drug Administration (FDA). Innovation of Stagnation, Challenge and Opportunity on the Critical Path to New Medicinal Products. Critical Path Report. Rockville, Md: FDA; March 2004.


2) US Department of Health and Human Services, Food and Drug Administration (FDA), Center for Evaluation and Research. Guidance for Industry: Investigators and Reviewers. Exploratory IND Studies. January 2006.


3) Jun. Zhang, Yong-ming Cai, Zong-peng Zhang, Duan-yun Si, Changxiao Liu. Phase 0 clinical trials: An efficient way to development of new drugs. Asian Journal of Pharmacodynamics and Pharmacokinetics 2010; 10(4):261-270.

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