Regulatory guidances

Department of Health and Human Services, FDA. Guidance for Industry Drug Metabolism /Drug Interaction Studies in the Drug Development Process Studies In Vitro. April 1997. URL http //www.fda.gov/cder/guidance/clin3.pdf [25 October 2005]. 

Another guideline from the EMEA, Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins [13], has a section on immunogenicity, which stresses the importance of correlating antibody responses to drug exposure or relevant PK parameters. 

Currently, the various regulatory documents recommend the need for immunogenicity assessment, but the recommendations on Nab assays may vary between documents. Due to the lack of detail or clarity of intent for immunogenicity assessment, different companies may have different interpretations of the expectations for immunogenicity testing, leading to different approaches between companies. 

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Potassium Bencyoate Considered to be GRA.S, Division of Regulatory Guidance, Bureau of Foods, Washington, D.C., Sept. 22,1982. 

The issue that must be managed is the appropriate threshold to communicate the change and initiate appropriate approval processes. Tolls subject to regulatory requirements may use the regulatory guidance as the threshold for management of change processes other tolls must establish the threshold appropriate to process risks, quality systems, and business concerns. 

Copies of referenced documents, including important published articles, official meeting minutes, or other regulatory guidance or advice should be provided in the reference section. 

Regulatory guidance and scientific consideration for residue analytical method development and validation... 

Interstate Technology and Regulatory Cooperation Work Group, Technical and Regulatory Guidance for In Situ Chemical Oxidation of Contaminated Soil and Groundwater. Available at http //www. itrcweb.org/ISCO-l.pdf, June 2001. 

Interstate Technology and Regulatory Council (ITRC), Regulatory Guidance for Permeable Reactive Barriers Designed to Remediate Chlorinated Solvents, December 1999. 

The final component of the regulatory/guidance summary discusses the construction of a hazardous waste landfill. The following section summarizes U.S. EPA s CQA program.1314... 

Considerable effort is often required to prepare sufficient quantities of key mammalian metabolites of drug candidates for biological activity evaluation or for use as analytical standards. The new regulatory guidance in drug development [5] will certainly lead to more emphasis on key human metabolite characterization. Microbial bioreactors can be used for... 

It is important to remember that respiratory sensitization and asthma are related, but not identical, pathologies [31]. Asthma is a specific syndrome which appears to have genetic as well as environmental causes and there are numerous potential triggers which have been identified by immunotoxicologists [32], However, asthma is not the same disease as other respiratory hypersensitivity syndromes (sometimes referred to as chemical asthma, etc.) [33, 34], Various regulatory guidance documents have sought to deal with the latter disease entities to ensure that xenobiotics are assessed appropriately for their ability to induce immune-based pulmonary hypersensitivity reactions [35-37],... 

There are a number of examples in which histopathology and the functional immuno-toxicity tests recommended by regulatory guidance documents would not detect known... 

Regulatory guidance for the conduct of clinical trials on vaccines is specific. Traditional phase I trials in normal volunteers are not conducted. Rather, all trials assess not only safety but also efficacy (or at least immunogenicity). Trials may well be challenge trials, that is, after immunization subjects are purposely challenged with exposure to the infective agent of concern. 

Cavero, I. and Crumb, W. (2005) The use of electrocardiograms in clinical trials a public discussion of the proposed ICH E14 regulatory guidance Expert Opinion on Drug Safety, 4, 795-799. 

There are a number of FDA regulatory guidances that are associated with IVIVC development and validation, as well as the application of IVIVC to SUPAC. The specific IVIVC guidance for oral modified-release formulations was first published in September 1997 (1). There are several guidances on SUPAC, including those for both modified release (2) and immediate-release solid oral dosage forms (3). The recent... 

The following sections provide examples of approaches to assess drug effects on the cardiovascular, respiratory, and central nervous systems in compliance with the current and emerging regulatory guidance documents.25,42 45 60... 

Regulatory guidance for non-clinical cardiovascular safety pharmacology testing is given in the ICH S7A and B.25,42 The effects of an NCE on blood pressure, heart rate, and the ECG should be evaluated. Furthermore, in vivo, in vitro, and ex vivo evaluations, including methods for (assessing) repolarization and conductance abnormalities, should... 

This chapter focuses on approaches to the validation of high-performance liquid chromatography methods based on regulatory guidance documents and accepted industry practices. The information in this chapter gives a brief review of the reasons for performing method validation and the regulations that describe this activity. Individual validation parameters are discussed in relation to the type of method to be validated. Examples of typical validation conditions are presented with references to additional information on individual topics. This chapter was written to help analysts responsible for method validation. 

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