Pre-clinical or non-clinical studies are required during drug development to evaluate safety in animals (toxicology) and pharmacokinetics and bioavailability (pharmacology) of drugs prior to initiating the clinical development of a drug. These studies must be performed following the Good Laboratory Practices (GLP) regulations, specified by the US FDA or principles and guidelines developed by the Organisation of Economic Co-operation and Development (OECD). Regulations for the GLP, specified in 21 CFR 58, related guidelines, including “questions and answers” documents, a training handbook and training manuals developed by the World Health Organization (WHO) are available to clarify the regulatory expectations with a view to assisting the sponsors of drugs and contract testing laboratories performing toxicology and pharmacology studies in complying with these regulations. Despite these guidance documents and training materials, GLP regulations are one of the most commonly misunderstood regulations for drug development and manufacturing operations with a number of myths about GLPs. This course will explain various elements of GLPs in detail with a view to comply with the regulations and Law as per regulatory requirements and expectations.
Analytical methods are required in evaluating pharmacology of drugs (pharmacokinetics and bioavailability) in animals and humans. The regulatory agencies in the US and Europe have termed these methods as bioanalytical methods. Most of these methods are analytical methods, but these methods when used to detect or quantify the drug in biological fluids or tissues have been referred as bioanalytical methods. Often these methods are confused with biological methods or bioassays commonly used in testing and characterization of biological products or biologics and also used in evaluating functionality (for example, Immunogenicity) of drugs and biologics (functional assays). Regulatory agencies have issued guidelines for validation of bioanalytical methods.
This course will discuss in details the use and validation of bioanalytical methods. For clinical evaluation of drugs, bioanalytical methods and other methods, such as biological assays, immunochemical assays, etc. are used. Clinical trials are conducted under the Good Clinical Practices (GCP) regulations, which mainly deal with conduct of clinical trials and provide not much information or guidelines for the methods used to test clinical samples. Bioanalytical methods used for clinical development are validated by the guidance provided by the regulatory agencies, but there is confusion in validation of biological assays, immunochemical assays, etc. used for clinical samples, as the ICH guidance for method validation (Q2R(1)) deals with methods used to test the product. This course will give an overview on the common practices and ways to validate methods used during clinical development of drugs.
Throughout the course, relevant examples with regard to meeting regulatory expectations will be discussed.
Upon completing this course the participants will understand:
- Good Laboratory Practices (GLP) regulations and their distinction from the current Good Manufacturing Practices (cGMP) regulations
- Myths and Regulatory Expectations about GLP
- Achieving Compliance with GLP regulations
- Challenges with complying with GLP regulations
- Bioanalytical methods and their distinction from Biological methods
- Validation of Bioanalytical Methods
- Validation of Biological, Immunochemical and other Methods used to evaluation clinical samples
….much, much more
Who will Benefit:
- Managers and Scientists involved in Drug Development from Pharmaceutical and Biotech Industry
- Contract Testing Laboratories performing toxicology and pharmacology studies
- Personnel from Laboratories performing Bioanalytical methods
- Personnel from Laboratories testing Clinical samples for determining efficacy of drugs and biologics
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