ashish prasad (15 Ergebnisse)

Zustand: New. pp. 204.

Soft cover. Zustand: New. UNIT I 12 Hours Documentation in the pharmaceutical industry: Master formula record, DMF (Drug master file). Distribution records. Generic drugs product development introduction, Hatch-Waxman Act and amendments, CRF (CODE OF FEDERAL REGULATION), ANDA regulatory approval process, NDA approval process, BE and drug product assessment, in-vivo, scale-up process approval changes, postmarketing surveillance, outsourcing BA and BE to CRO. Regulatory requirement for product approval: API, biologics, novel, therapies obtaining NDA, ANDA for generic drugs ways means US registration for foreign drugs. UNIT II 12 Hours CMC, post-approval regulatory affairs, Regulation for combination products and medical devices. CTD and ECTD format, Regulatory requirement of EU, MHRA, TGA, and row Countries. UNIT III 12 Hours Nonclinical drug development: Global submission of IND, NDA, ANDA. Investigation of medicinal product dossier, (IMPD) and (IB). UNIT IV 12 Hours Clinical trials: Developing clinical protocols. Institutional review board/ independent ethical committee Formulation and working procedure informed consent process and procedures. HIPAA new, requirement to clinical study process, pharmacovigilance safety monitoring in clinical trials.

Paperback. Zustand: Brand New. 116 pages. 8.66x5.91x0.27 inches. In Stock.

HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

Hardcover. Zustand: Brand New. 305 pages. 9.25x6.25x1.00 inches. In Stock.

Buch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book presents the recent advances including tools and techniques in the constantly changing landscape of machine learning (ML). This would enable the readers with a strong understanding of critical issues in ML by providing both broad and detailed perspectives on cutting-edge theories, algorithms, and tools. This will become a single source of reference on conceptual, methodological, technical, and managerial issues, as well as provide insight into emerging trends and future opportunities in the discipline of ML. This book contains altogether 36 chapters in the area of ML and its applications.

Buch. Zustand: Neu. Neuware -This book presents the recent advances including tools and techniques in the constantly changing landscape of machine learning (ML). This would enable the readers with a strong understanding of critical issues in ML by providing both broad and detailed perspectives on cutting-edge theories, algorithms, and tools. This will become a single source of reference on conceptual, methodological, technical, and managerial issues, as well as provide insight into emerging trends and future opportunities in the discipline of ML. This book contains altogether 36 chapters in the area of ML and its applications.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 436 pp. Englisch.

Taschenbuch. Zustand: Neu. Neuware -M¿icrobial biotechnology is an important area that promotes advanced research into using microbes for value-added products, human nutrition, and the overall wellbeing of society. This book presents the latest information on the use of microbes for sustainable development, and highlights state-of-the-art biotechnological techniques used to harness microbial biotechnological traits on a commercial scale. Gathering contributions from authoritative researchers in the field, it addresses recent advances in microbial biotechnological approaches that offer sustainable options for future generations.Exploring a broad range of microbial products and their uses, the book specifically places emphasis on the application of microorganisms in healthcare, the environment and industry. It also discusses various compound classes derived from microbial metabolites. Pursuing a holistic approach to recent advances in the utilization of various microbes as biotechnological tools, the book also covers traditional uses, and explores emerging strategies to harness their full potential. Accordingly, it offers a valuable resource for researchers and graduate students alike.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 384 pp. Englisch.

Buch. Zustand: Neu. Neuware -M¿icrobial biotechnology is an important area that promotes advanced research into using microbes for value-added products, human nutrition, and the overall wellbeing of society. This book presents the latest information on the use of microbes for sustainable development, and highlights state-of-the-art biotechnological techniques used to harness microbial biotechnological traits on a commercial scale. Gathering contributions from authoritative researchers in the field, it addresses recent advances in microbial biotechnological approaches that offer sustainable options for future generations.Exploring a broad range of microbial products and their uses, the book specifically places emphasis on the application of microorganisms in healthcare, the environment and industry. It also discusses various compound classes derived from microbial metabolites. Pursuing a holistic approach to recent advances in the utilization of various microbes as biotechnological tools, the book also covers traditional uses, and explores emerging strategies to harness their full potential. Accordingly, it offers a valuable resource for researchers and graduate students alike.Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg 384 pp. Englisch.

Buch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - M icrobial biotechnology is an important area that promotes advanced research into using microbes for value-added products, human nutrition, and the overall wellbeing of society. This book presents the latest information ontheuseof microbes for sustainable development, and highlights state-of-the-artbiotechnological techniques used to harness microbial biotechnological traits on a commercial scale. Gathering contributions from authoritative researchers in the field, it addresses recent advances in microbial biotechnological approachesthat offer sustainable options for future generations.Exploring a broad range of microbial products and their uses, the book specifically places emphasis on theapplicationof microorganisms in healthcare, the environment and industry. It also discusses various compound classes derived from microbial metabolites.Pursuing a holistic approach to recent advances in the utilization of various microbes as biotechnological tools, the book also covers traditional uses, and explores emerging strategies to harness their full potential.Accordingly, it offers a valuable resource for researchers and graduate students alike.

Taschenbuch. Zustand: Neu. Druck auf Anfrage Neuware - Printed after ordering - M icrobial biotechnology is an important area that promotes advanced research into using microbes for value-added products, human nutrition, and the overall wellbeing of society. This book presents the latest information ontheuseof microbes for sustainable development, and highlights state-of-the-artbiotechnological techniques used to harness microbial biotechnological traits on a commercial scale. Gathering contributions from authoritative researchers in the field, it addresses recent advances in microbial biotechnological approachesthat offer sustainable options for future generations.Exploring a broad range of microbial products and their uses, the book specifically places emphasis on theapplicationof microorganisms in healthcare, the environment and industry. It also discusses various compound classes derived from microbial metabolites.Pursuing a holistic approach to recent advances in the utilization of various microbes as biotechnological tools, the book also covers traditional uses, and explores emerging strategies to harness their full potential.Accordingly, it offers a valuable resource for researchers and graduate students alike.

Paperback. Zustand: Brand New. 384 pages. 9.25x6.10x0.91 inches. In Stock.

Hardcover. Zustand: Brand New. 384 pages. 9.25x6.10x1.06 inches. In Stock.

Hardcover. Zustand: Brand New. 434 pages. 9.25x6.10x9.21 inches. In Stock.