Nonclinical conduct

Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study Sec. 58.120 Protocol. 

Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals Notice Stability testing of new drug substances and products Stability testing Stability testing... 

Safety pharmacology is the evaluation and study of the pharmacologic effects of a potential drug that is unrelated to the desired therapeutic effect, and therefore may present a hazard—particularly in individuals who already have one or more compromised or limited organ system functions. Unlike other nonclinical evaluations of the safety of a drug, these evaluations are usually conducted at doses close to the intended clinical dose. 

Sponsor 1) A person who initiates and supports, by provision of financial or other resources, a (nonclinical laboratory) study 2) a person who submits a (nonclinical laboratory) study to the EPA (FDA) in support of an application for a research or marketing permit or 3) a testing facility, if it both initiates and actually conducts the study. 

Study director The individual responsible for the overall conduct of a (nonclinical laboratory) study. 

Testing facility (both EPA and FDA) A person who actually conducts a (nonclinical laboratory) study, i.e., who actually uses the test substance (article) in a test system. 

The above table also reflects the marketing recommendations in all three ICH regions except that a chronic nonrodent study is recommended for clinical use > 1 month Source Taken from the ICH M3 guideline. Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, November 1997 and updated November 2000, Available at http //www.fda.gov/cder/guidance. 

Conduct of a nonclinical laboratory study Reporting of nonclinical laboratory study results Storage and retrieval of records and data Retention of records Purpose... 

Personnel must have the education, training, and experience to conduct the nonclinical studies. 

Nonclinical laboratory studies must be conducted in accordance with the protocols. 

A Sponsor submits a clinical trial application to the Competent Authority in each member state where the trials are to be conducted. The Competent Authority has 60 days to review and approve or reject the application. Application is in prescribed forms and covers the proposed clinical trial protocol, manufacturing, and quality controls on the drug, and supporting data, such as (1) chemical, pharmaceutical, and biological data, (2) nonclinical pharmacological and toxicological data, and (3) clinical data and previous human experience. The supporting data are submitted in the Common Technical Document (CTD) format (see Section 7.11). 

Maintain a copy of a master schedule sheet of all (nonclinical laboratory) studies conducted at the testing facility. 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

Currently 23 Indian laboratories have been accredited by the Indian national GLP compliance monitoring authority as per the provisions of the OECD Principles of GLP to conduct nonclinical health and environmental safety studies. The Indian system of GLP inspection, accreditation, and monitoring of test facilities was started in 2004 (India GLP). 

The test facilities in India and China have evolved over the years and conduct a range of nonclinical safety assessment studies for in-house drug development, and also provide service as contract research organizations (CROs) for sponsors not only from India and China but also from overseas pharmaceutical and agrochemical companies. 

The Schedule Y (12) of nonclinical safety evaluation also describes application of GLP for the animal studies to be conducted in an accredited laboratory. 

Nonclinical toxicity testing and safety evaluation data of an IND needed for fhe conduct of different phases of clinical frials... 

ICH (2009) Harmonised Tripartite Guideline M3(R2). Guidance on nonclinical safety studies for the conduct of human cKnical trials and marketing authorization for pharmaceuticals... 

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