Regulatory Affairs in the Pharmaceutical Industry
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry.
Uloženo v:
| Hlavní autoři: | , |
|---|---|
| Médium: | E-kniha |
| Jazyk: | angličtina |
| Vydáno: |
Chantilly
Elsevier Science & Technology
2021
Academic Press |
| Vydání: | 1 |
| Témata: | |
| ISBN: | 9780128222119, 0128222115 |
| On-line přístup: | Získat plný text |
| Tagy: |
Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
|
Obsah:
- 1.3.3.1 Goals of abbreviated new drug application -- 1.3.3.2 Content and format of abbreviated new drug application -- 1.3.3.3 Approval time for abbreviated new drug application -- 1.3.3.4 Generic drug product development -- 1.3.3.5 Selection criteria for formulation of a generic drug product -- 1.3.3.5.1 Generic drug approval process -- 1.4 Hatch-Waxman Act and amendments -- 1.4.1 Orange Book -- 1.4.1.1 Main uses of Orange Book -- 1.4.2 Biologics license application -- 1.4.3 Marketing Authorization Application -- 1.4.4 Scale-up, process approval changes, and postmarketing surveillance -- 1.4.5 Food and Drug Administration Modernization Act -- 1.4.6 Postmarketing surveillance -- 1.4.7 Good manufacturing practice certification -- 1.4.8 Application for getting a certificate of pharmaceutical product -- 1.4.8.1 Contents of certificate of pharmaceutical product -- 1.4.9 Patent certifications -- 1.4.10 Trademark registration -- 1.4.11 Copyright registration -- 1.4.12 Design registration in pharmaceutical context -- 1.5 Conclusion -- References -- 2 Regulatory requirement for the approval of novel, nanotechnology-based biological products -- 2.1 Introduction -- 2.2 Regulatory requirements and active pharmaceutical ingredients approval process -- 2.2.1 Registration of active pharmaceutical ingredients -- 2.2.2 Drug master file -- 2.2.3 Recent changes in the drug master file rules -- 2.2.4 Responsibilities of active pharmaceutical ingredients manufacturer -- 2.2.5 Letter of access -- 2.2.6 Regulatory requirement for drug approval in the United States -- 2.2.6.1 Investigational new drug -- 2.2.6.2 New drug application -- 2.2.6.2.1 Goal of new drug application -- 2.2.6.2.2 New drug application contents -- 2.2.6.3 Abbreviated new drug application -- 2.2.6.3.1 Content and format of abbreviated new drug application
- 3.2.3.11 "E11: Clinical Investigation of Medicinal Products in the Pediatric Population" -- 3.2.3.12 "E12: Principles for Clinical Evaluation of New Antihypertensive Drugs" -- 3.2.3.13 "E14: The Clinical Evaluation of Qt/Qtc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic D... -- 3.2.3.14 "E15: Definitions for Genomic Biomarkers, Pharmaco-Genomics, Pharmacogenetics, Genomic Data and Sample Coding Cate... -- 3.2.3.15 "E16: Biomarkers Related to Drug or Biotechnology Product Development" -- 3.2.3.16 "E17: General Principles of Planning and Design of Multi-Regional Clinical Trials" -- 3.2.3.17 "E18: Genomic Sampling and Management of Genomic Data" -- 3.2.3.18 "E19: Optimization of Safety Data Collection" -- 3.2.3.19 "E20: Adaptive Clinical Trials" -- 3.2.4 Multidisciplinary guidelines -- 3.2.4.1 M1: Medical Dictionary for Regulatory Activities -- 3.2.4.2 M2: Electronic standards -- 3.2.4.3 M3: Nonclinical Safety Studies -- 3.2.4.4 M4: Common Technical Document -- 3.2.4.5 "M5: Data Elements and Standards for Drug Dictionaries" -- 3.2.4.6 "M6: Virus and Gene Therapy Vector Shedding and Transmission" -- 3.2.4.7 "M7: Mutagenic Impurities (Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limi... -- 3.2.4.8 "M8: Electronic Common Technical Document (ECTD)" -- 3.2.4.9 "M9: Biopharmaceutics Classification System-Based Biowaivers" -- 3.2.4.10 "M10: Bioanalytical Method Validation" -- 3.2.4.11 "M11: Clinical Electronic Structured Harmonised Protocol (CESHARP)" -- 3.2.4.12 "M12: Drug Interaction Studies" -- 3.3 Conclusion -- References -- 4 Regulatory affairs for chemistry, manufacturing, and controls -- 4.1 Introduction -- 4.2 Chemistry, manufacturing, and controls submission at investigational new drug (IND) stage
- Front Cover -- Regulatory Affairs in the Pharmaceutical Industry -- Copyright Page -- Dedication -- Contents -- List of contributors -- Editor biographies -- Preface -- 1 Drug regulatory affairs: an introduction -- 1.1 Introduction -- 1.1.1 Reason for the requirement of a drug regulatory department in the pharmaceutical industry -- 1.1.2 Responsibilities and duties of Drug Regulatory Affair professionals -- 1.1.3 Different regulatory agencies regulating pharmaceutical industries worldwide -- 1.1.3.1 International Council for Harmonisation -- 1.1.3.2 Organization of ICH -- 1.1.3.3 Process of harmonization -- 1.1.3.4 ICH guidelines for pharmaceuticals -- 1.2 Pharmaceutical regulatory affairs: documentation -- 1.2.1 Dossiers -- 1.2.1.1 Pharmaceutical dossier -- 1.2.1.2 Preclinical dossier -- 1.2.2 Drug master file -- 1.2.2.1 Type I: Manufacturing site, facilities, operating procedures, and personnel -- 1.2.2.2 Type II: Drug substance, drug substance intermediate, and material used in their preparation, or drug product -- 1.2.2.2.1 Drug product -- 1.2.2.3 Type III: Packaging material -- 1.2.2.4 Type IV: Excipient, colorant, flavor, essence, or material used in their preparation -- 1.2.2.5 Type V: Food and Drug Administration-accepted reference information -- 1.2.3 Master formula record -- 1.2.4 Batch manufacturing formula record -- 1.2.5 Distribution record -- 1.2.5.1 Objective -- 1.2.5.2 Contents of distribution record -- 1.3 Applications filed by the Drug Regulatory Affairs department -- 1.3.1 Investigational new drug application -- 1.3.2 New drug application -- 1.3.2.1 Goals of new drug application -- 1.3.2.2 When will we go for new drug application? -- 1.3.2.3 Content and format of an new drug application application -- 1.3.2.4 Review of new drug application -- 1.3.3 Abbreviated new drug application
- 2.3 Novel drugs and their regulatory requirements -- 2.3.1 Rules for approval of novel drugs -- 2.3.2 Approaches for approval -- 2.3.2.1 Fast track -- 2.3.2.2 Breakthrough therapy -- 2.3.2.3 Priority review -- 2.3.2.4 Accelerated approval -- 2.3.3 CDSCO and rules for novel drug marketing -- 2.3.3.1 Rules for novel drug marketing -- 2.4 Guidelines on approval of novel drug delivery systems -- 2.5 Regulation for nanotechnology products -- 2.5.1 FDA's methodology for various product classes -- 2.5.2 Data required for nanopharmaceuticals evaluation -- 2.6 Biologics and its regulatory guidelines -- 2.6.1 International standards for regulation of biologics -- 2.6.2 U.S. Food and Drug Administration biologics team -- 2.6.3 Postlicensing monitoring -- 2.6.3.1 Product release -- 2.6.3.2 Inspections -- 2.6.3.3 Postlicensing surveillance -- 2.6.3.4 Recall and revocation -- 2.6.3.5 Approval of changes in manufacturing -- 2.6.3.6 Approval of new patterns -- 2.7 Conclusion -- References -- 3 International Council for Harmonisation (ICH) guidelines -- 3.1 Introduction -- 3.1.1 Opportunities and difficulties -- 3.1.2 History of ICH -- 3.1.2.1 Missions -- 3.1.2.2 ICH organizational structure -- 3.1.3 Progression of ICH harmonization -- 3.2 Outlines of ICH guidelines -- 3.2.1 Quality guidelines -- 3.2.1.1 Q1 Guidelines -- 3.2.1.1.1 "Stability Testing Designed For New Formulation and Dosage Form" -- New dosage form -- Photostability studies -- Stability commitment -- Evaluation -- Statement/labeling -- 3.2.1.2 "Q2 (R1): Validation of Analytical Procedures: Text and Methodology" -- 3.2.1.3 Q3 Guidelines -- 3.2.1.4 Q4: Pharmacopeia -- 3.2.1.5 Q5 Guidelines -- 3.2.1.6 Q6 Guidelines -- 3.2.1.7 "Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" -- 3.2.1.8 "Q8 (R2): Pharmaceutical Development" -- 3.2.1.9 "Q9: Quality Risk Management"
- 3.2.1.10 "Q10: Pharmaceutical Quality System" -- 3.2.1.11 "Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)" -- 3.2.1.12 "Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management" -- 3.2.1.13 "Q13: Continuous Manufacturing of Drug Substances and Drug Products" -- 3.2.1.14 "Q14: Analytical Procedure Development" -- 3.2.2 Safety guidelines -- 3.2.2.1 S1 Guidelines -- 3.2.2.2 "S2 (R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use" -- 3.2.2.3 S3 Guidelines -- 3.2.2.4 "S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)" -- 3.2.2.5 "S5-R2: Detection of Toxicity to Reproduction for Medicinal Products and Toxicity to Male Fertility" -- 3.2.2.6 "S6: Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals" -- 3.2.2.7 S7 Guidelines -- 3.2.2.8 "S8: Immunotoxicity Studies for Human Pharmaceuticals" -- 3.2.2.9 "S9: Nonclinical Evaluation for Anticancer Pharmaceuticals" -- 3.2.2.10 "S10: Photosafety Evaluation of Pharmaceuticals" -- 3.2.3 Efficacy guidelines -- 3.2.3.1 "E1: The Extent of Population Exposure to Assess Clinical Safety" -- 3.2.3.2 E2 Guidelines -- 3.2.3.3 "E3: Structure and Content of Clinical Study Reports" -- 3.2.3.4 "E4: Dose-Response Information to Support Drug Registration" -- 3.2.3.5 "E5 (R1): Ethnic Factors in the Acceptability of Foreign Clinical Data" -- 3.2.3.6 "E6 (R1): Guideline for Good Clinical Practice" -- 3.2.3.7 "E7: Studies in Support of Special Populations: Geriatrics" -- 3.2.3.8 "E8: General Considerations for Clinical Trials" -- 3.2.3.9 "E9: Statistical Principles for Clinical Trials" -- 3.2.3.10 "E10: Choice of Control Group and Related Issues in Clinical Trials"
- 4.3 Chemistry, manufacturing, and controls submission at new drug application (NDA) stage