Thông tin về Hóa học, Sản xuất và Kiểm soát trong các Đơn Xin cấp Giấy phép (NDA và ANDA), Các Bổ sung, Báo cáo Hàng năm và các Hồ sơ Quy định khác

Good Guidance Practices, Federal Register, 56468-56480, September 19, 2000. International Conference on Harmonization Q6A Guideline: Specifications for New Drug Substances and Products: Chemical Substances, October 1999. Center for Drug Evaluation and Research Guideline: Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, February 1987. International Conference on Harmonization Q3A Guideline: Impurities in New Drug Substances, March 1995. Center for Drug Evaluation and Research Guidance: NDAs: Impurities in Drug Substances, February 2000. Center for Drug Evaluation and Research Guideline: Guideline for Drug Master Files, September 1989. Center for Drug Evaluation and Research Guidance: ANDAs: Impurities in Drug Substances, November 1999. Center for Drug Evaluation and Research Guideline: Submitting Documentation for the Manufacture of and Controls for Drug Products, February 1987. International Conference on Harmonization Q3B Guideline: Impurities in New Drug Products, November 1996. International Conference on Harmonization Q3C Guideline: Impurities: Residual Solvents, July 1997. Center for Drug Evaluation and Research Guidance: Container Closure Systems for Packaging Human Drugs, May 1999. Center for Drug Evaluation and Research Guideline: Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics, February 1987. Center for Drug Evaluation and Research Guidance: Stability Testing of Drug Substances and Drug Products (draft), June 1998. Center for Drug Evaluation and Research Guideline: Submitting Documentation for the Stability of Human Drugs and Biologics, February 1987. International Conference on Harmonization Q1A Guideline: Harmonized Tripartite Guideline for Stability Testing of New Drug Substances and Products, October 1993. International Conference on Harmonization Q1B: Guideline for Photostability Testing of New Drug Substances and Products, November 1996. International Conference on Harmonization Q1C Guideline: Guideline for Stability Testing of New Dosage Forms, November 1996. International Conference on Harmonization Q5C Guideline: Stability Testing of Biotechnological/Biological Products, November 1995. International Conference on Harmonization Q1A(R) Guideline: Stability Testing of New Drug Substances and Products (Revised Guideline), November 2000. Center for Drug Evaluation and Research Guidance: Submitting Samples and Analytical Data for Methods Validation, February 1987. Center for Drug Evaluation and Research Guidance: Analytical Procedures and Methods Validation (draft), August 2000. International Conference on Harmonization Q2A Guideline: Text on Validation of Analytical Procedures, October 1995. International Conference on Harmonization Q2B Guideline: Validation of Analytical Procedures: Methodology, November 1996. Center for Drug Evaluation and Research Guidance: Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products, November 1994. Center for Drug Evaluation and Research Guidance: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products, November 1995. Center for Drug Evaluation and Research Guidance: INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products Chemistry, Manufacturing, and Controls Content and Format (draft), February 1999. Center for Drug Evaluation and Research Guidance: Drug Master Files for Bulk Antibiotic Drug Substances, November 1989. Center for Drug Evaluation Research Guidance: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Chemistry, Manufacturing, and Content Format (draft), November 1998. Center for Drug Evaluation and Research Guidance: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing, and Controls Documentation (draft), May 1999. Center for Drug Evaluation and Research Guideline: Format and Content of the Chemistry, Manufacturing and Controls Section of an Application, February 1987. Center for Drug Evaluation and Research Guideline: Format and Content of the Microbiology Section of an Application, February 1987. 32. International Conference on Harmonization M4Q Guideline: The Common Technical Document, Quality Section, November 2000. Center for Drug Evaluation and Research Guidance: Format and Content for the CMC Section of an Annual Report, September 1994. Center for Drug Evaluation and Research Guidance: Changes to an Approved NDA or ANDA, November 1999. Center for Drug Evaluation and Research Guidance: BACPAC 1: Intermediates in Drug Substance Synthesis/Bulk Actives Post-Approval Changes: Chemistry, Manufacturing, and Controls Documentation, February 2001. Center for Drug Evaluation and Research Guidance. BACPAC 2: Drug Substance Synthesis/Bulk Actives Post-Approval Changes: Chemistry, Manufacturing, and Controls Documentation (draft in preparation). Center for Drug Evaluation and Research Guidance: SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and in Vivo Bioequivalence Documentation, November 1995. Center for Drug Evaluation and Research Guidance: SUPACMR: Modified-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and in Vivo Bioequivalence Documentation, October 1997. Center for Drug Evaluation and Research Guidance: SUPAC-SS: Nonsterile Semisolid Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, in Vitro Dissolution Testing, and in Vivo Bioequivalence Documentation, May 1997. Center for Drug Evaluation and Research Guidance: SUPAC-IR: Questions and Answers about SUPAC-IR, February 1997. Center for Drug Evaluation and Research Guidance: SUPACIR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum, January 1999. Center for Drug Evaluation and Research Guidance: Post-Approval Changes-Analytical Testing Laboratory Sites, April 1998. Center for Drug Evaluation and Research Guidance. Post-Approval Changes-Sterile Aqueous Solutions (PACSAS) (draft in preparation). Center for Drug Evaluation and Research Guidance. Post-Approval Changes-Packaging (PACPAC) (draft in preparation). Center for Drug Evaluation and Research Guidance. Analytical Procedures Post-Approval Changes (APPAC) (draft in preparation). Center for Drug Evaluation and Research Guidance: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, October 2000. Center for Drug Evaluation and Research Guidance: IND Meetings for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information, May 2001. Center for Drug Evaluation and Research Guidance: Formal Meetings with Sponsors and Applicants for PDUFA Products, February 2000. Center for Drug Evaluation and Research Guidance: Fast Track Drug Development-Designation, Development, and Application Review, September 1998. Center for Drug Evaluation and Research Manual of Policies and Procedures 4512.1, Formal Meetings between CDER and CDER's External Constituents, November 1999. T. Layloff, et. al., The U.S. FDA Regulatory Methods Validation Program for New and Abbreviated New Drug Applications, Pharm. Tech. and Biopharm., January 2000. International Conference on Harmonization Q5A Guideline: Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, March 1997. International Conference on Harmonization Q5B Guideline: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products, November 1995. International Conference on Harmonization Q5D Guideline: Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/ Biological Products, July 1997. International Conference on Harmonization Q6B Guideline: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products, March 1999. International Conference on Harmonization M1 Guideline: Medical Terminology, MedDRA website, www.ifpma.org/ ichMedDRA.html. International Conference on Harmonization M2 Guideline: Electronic Standards for the Transfer of Regulatory Information and Data (ESTRI), ESTRI website, www.fda.gov/cder/m2/m2-main.htm. International Conference on Harmonization M3 Guideline: Timing of Pre-clinical Studies in Relation to Clinical Trials, July 1997 International Conference on Harmonization M4 Guideline: The Common Technical Document, November 2000.