Data Packages

Stability Data Package for Registration Applications in Climatic Zones III and IV Analytical Validation... 

The importation of data from one electronic data system to another is improving. Some systems import weather data and sample chains of custody, such as shipping conditions, sample handling, etc., into the field raw data package. This allows for simplified reporting and tabulation. Data transmission over the Internet is improving and is already far superior to regular mail and even next-day delivery services. 

In electronic data packages used in held studies, there are some electronic data that are directly entered by the held investigator (FI) and some that are generated by the program (e.g., dates and times). Both types of raw data need to be verified by QA personnel, who should check not only directly entered data, but also computer-entered data. In order to conduct a thorough data audit, QA should determine which data are direct entry and which are automatic. 

In this paper, then, the previously developed model (7) is extended to the calculation of erosion characteristics of a well described polymeric delivery system, the acid-catalyzed erosion of poly (ortho ester)s (2-6). This system is chosen as the example system because of the completeness of the data package in the open literature. It is expected that this modelling approach is also useful for other hydrolytically unstable polymeric drug delivery systems. 

New Zealand GIS data package and prospectivity modelling. Published jointly by Crown Minerals, Ministry of Economic Development and Institute of Geological Nuclear Sciences. 

The standard toxicological data package for any new drug entity typically evaluates... 

Not all petitions will need to be supported by the same quantity and quality of data. The data and information needs outlined on the website should not be regarded as absolute. Questions regarding the tailoring of the data package for specific cases may be discussed with agency personnel prior to submitting a petition. 

Under the BPD, the biocidal substances are evaluated centrally by the EU Commission. The evaluation is based upon a very extensive data package submitted by the biocide substance manufacturer including a risk assessment of the use of the biocide in AF products. The outcome of the evaluation by the Commission is to decide whether the biocide is prone to be included in a positive list, also termed Annex I, or not. 

In US, AF products need a registration both at federal and at state level. Registration/regulation of AF paints is governed by the Federal Insecticide, Fungicide, and Rodenticide Act FIFRA (US, 2004) and administered by US Environmental Protection Agency. Extensive data packages need to be submitted by the biocide producers and the paint manufacturers. The decision for approval of products is based upon a risk benefit balance evaluation process. 

Part lA Administrative data, packaging, samples Part IB SPC, package leaflets Part IC Expert reports... 

The full data package was submitted and assessed by assessors from each of the three disciplines. The Committee on Safety of Medicines and its sub-committees then considered their assessment report. If the decision was positive then a certificate was issued. If the decision was negative, then the applicant had the same appeal rights as those that apply to a marketing authorisation application (see Section 17.8.1). 

ICH QIF Stability data package for registration in climatic zones III and IV Step 5 (2003)... 

A Clinical Trial Exemption (CTX) Scheme was introduced in Australia in 1987, with the intention of encouraging clinical trial activity. However, in addition to the aforementioned TGA restrictions, which required all clinical trials of an active substance underway in Australia to be completed before the review of a general marketing application relating to that substance, the specified data package included requirements unique to Australia, and the 60 working day review period compared with a 35 calendar day review imder the UK CTX Scheme. 

The TGA has endeavoured to encourage the submission of paediatric data packages by offering fee reductions for products that are not commercially viable or whose supply is in the public interest, waiving fees for orphan drugs and indications, and by accepting literature-based submissions. The TGA has also adopted... 

Current data on atmospheric C02 concentrations and temporal trends as well as those of other trace gases are available from the U.S. Department of Energy s Carbon Dioxide Information Analysis Center (CDIAC) (World Wide Web page is http //cdiac.esd.ornl.gov/cdiac). CDIAC also has available a number of additional data packages on global change issues such as trends in temperature and precipitation. 

McGrail, B. P., Icenhower, J. P., Martin, P. F., Schaef, H. T., O Hara, M. J., Rodriguez, E. A. Steele, J. L. 2001 i). Waste Form Release Data Package for the 2001 Immobilized Low-Activity Waste Performance Assessment. Pacific Northwest National Laboratory, PNNL-13043, Rev. 2, Richland, WA. 

The guidance for industry Q1A (R2) [7] defines requirements for API stability data package submission with drug applications in the EU, Japan, and the United States. 

U.S. Food and Drug Administration (FDA) (2004), Guidance for industry, ICH Q1F, Stability data package for registration applications in climatic zones III and IV, FDA, Rockville, MD. 

Developed with a Proprietary Pharmaceutical Data Package... 

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