Generic Drug Product Development
portes grátis
Generic Drug Product Development
Solid Oral Dosage Forms, Second Edition
Kanfer, Isadore; Shargel, Leon
Taylor & Francis Ltd
10/2024
398
Mole
9781032920603
Pré-lançamento - envio 15 a 20 dias após a sua edição
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Generic Drug Product Development and Therapeutic Equivalence. Active Pharmaceutical Ingredients.
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms. Experimental Formulation Development. Scale-up, Technology Transfer, and Process Performance Qualification. Drug Stability. Quality Control and Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory Approval Process. Bioequivalence and Drug Product Assessment: In Vivo. Statistical Considerations for Establishing Bioequivalence. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing. Index.
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms. Experimental Formulation Development. Scale-up, Technology Transfer, and Process Performance Qualification. Drug Stability. Quality Control and Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory Approval Process. Bioequivalence and Drug Product Assessment: In Vivo. Statistical Considerations for Establishing Bioequivalence. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Drug Product;ANDA Sponsor;dosage;Dosage Form;form;ANDA Application;substance;Oral Solid Dosage Form;abbreviated;Bioequivalence Studies;new;ANDA Submission;applications;Generic Drug;solid;Drug Substance;oral;Reference Product;forms;API Manufacturer;bioequivalence;ANDA Approval;Generic Drug Product;FDA Investigator;Dissolution Profiles;Wet Granulation;Drug Product Performance;DMF;DESI;Orange Book;Pa;Vitro Dissolution;Brand Lot;NDA Sponsor;Pharmacopeial Forum
Generic Drug Product Development and Therapeutic Equivalence. Active Pharmaceutical Ingredients.
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms. Experimental Formulation Development. Scale-up, Technology Transfer, and Process Performance Qualification. Drug Stability. Quality Control and Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory Approval Process. Bioequivalence and Drug Product Assessment: In Vivo. Statistical Considerations for Establishing Bioequivalence. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing. Index.
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms. Experimental Formulation Development. Scale-up, Technology Transfer, and Process Performance Qualification. Drug Stability. Quality Control and Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory Approval Process. Bioequivalence and Drug Product Assessment: In Vivo. Statistical Considerations for Establishing Bioequivalence. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing. Index.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Drug Product;ANDA Sponsor;dosage;Dosage Form;form;ANDA Application;substance;Oral Solid Dosage Form;abbreviated;Bioequivalence Studies;new;ANDA Submission;applications;Generic Drug;solid;Drug Substance;oral;Reference Product;forms;API Manufacturer;bioequivalence;ANDA Approval;Generic Drug Product;FDA Investigator;Dissolution Profiles;Wet Granulation;Drug Product Performance;DMF;DESI;Orange Book;Pa;Vitro Dissolution;Brand Lot;NDA Sponsor;Pharmacopeial Forum
