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Draft - Clinical Trial Site Information (CTSI) Form for : Clinical Trial Applications and/or Amendments
The CTSI form is required to be submitted by the clinical trial sponsor prior to initiating a clinical trial or implementing subsequent amendment(s) at a clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations. It is important to note that the CTSI form should only be submitted once it is fully completed (i.e., only if the dates for the commencement of the trial and of the approval by the Research Ethics Board are known). Full document...
Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals
The scope and detail of information submitted in support of the Quality portion of a Clinical Trial Application should enable Health Canada to make an adequate assessment of the characteristics of the drug substance and the drug product. Full document...
Q4B Draft (Step 2) ICH Guidance : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter Annex 2
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). Full document...
Q4B Draft (Step 2) ICH Guidance : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter Annex 3
This annex is the result of the Q4B process for Test for Particulate Contamination: Sub-Visible Particles. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). Full document...
Q4B Draft (Step 2) ICH Guidance : Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) Annex 2
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). Full document...
Q4B Draft (Step 2) ICH Guidance : Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) Annex 3
This annex is the result of the Q4B process for Test for Particulate Contamination: Sub-Visible Particles. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). Full document...
Q8 Draft (Step2) ICH Guidance: Pharmaceutical Development Annex
The annex is not intended to establish new standards; however, it shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms. Full document...
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