Pharmaceutical Regulatory Science (Theory) Paper Code -BP804 ET

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Author :
Publisher : Shashwat Publication
ISBN 13 : 9360870218
Total Pages : 179 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis Pharmaceutical Regulatory Science (Theory) Paper Code -BP804 ET by : Dr. Jhansee Mishra, Mrs. Minakshi Verma, Mr. Sarada Sarangi, Mr. Ashish Kumar Gupta, Mr. Satish Gupta, Mr. Vivek Patel

Download or read book Pharmaceutical Regulatory Science (Theory) Paper Code -BP804 ET written by Dr. Jhansee Mishra, Mrs. Minakshi Verma, Mr. Sarada Sarangi, Mr. Ashish Kumar Gupta, Mr. Satish Gupta, Mr. Vivek Patel and published by Shashwat Publication. This book was released on 2024-08-29 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Present book “ Pharmaceutical Regulatory Science” is a culmination of very honest and Sincere, keeping in view the level and aspirations of Pharmacy student at the undergraduate level,in accordance with the syllabus of Pharmacy Council of India.

Neuromuscular Disorders

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Publisher : Springer
ISBN 13 : 9811053618
Total Pages : 534 pages
Book Rating : 4.8/5 (11 download)

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Book Synopsis Neuromuscular Disorders by : Satish V. Khadilkar

Download or read book Neuromuscular Disorders written by Satish V. Khadilkar and published by Springer. This book was released on 2017-12-28 with total page 534 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a concise overview of the diagnosis and therapy of a wide variety of neuromuscular disorders, in tabulated form and with illustrative cases. Treating neuromuscular disorders calls for a sound, step-by-step clinical approach based on differential diagnosis and laboratory investigations. Yet to date, there has been no single, compact book that offers all the relevant information related to the management of these disorders. This book fills that gap, presenting the state of the art in the field and addressing practical problems together with their solutions. Each chapter covers disorder characteristics, clinical differentiating points, relevant investigations and their interpretation, available genetic testing, best management approaches and counselling. Illustrative cases provide valuable insights, while extensive tables and illustrations mean that information can be rapidly found.

Approved Prescription Drug Products

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Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Approved Prescription Drug Products by :

Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1984 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.

Plant, Soil and Microbes in Tropical Ecosystems

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Publisher : Springer Nature
ISBN 13 : 9811633649
Total Pages : 397 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Plant, Soil and Microbes in Tropical Ecosystems by : Suresh Kumar Dubey

Download or read book Plant, Soil and Microbes in Tropical Ecosystems written by Suresh Kumar Dubey and published by Springer Nature. This book was released on 2021-09-25 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the multitude of interactions between plant, soil, and micro-organisms. It emphasizes on how growth and development in plants, starting from seed germination, is heavily influenced by the soil type. It describes the interactions established by plants with soil and inhabitant microbial community. The chapters describe how plants selectively promote certain microorganisms in the rhizospheric ecozone to derive multifarious benefits such as nutrient acquisition and protection from diseases. The diversity of these rhizospheric microbes and their interactions with plants largely depend on plant genotype, soils attributes, and several abiotic and biotic factors. Most of the studies concerned with plant–microbe interaction are focused on temperate regions, even though the tropical ecosystems are more diverse and need more attention. Therefore, it is crucial to understand how soil type and climatic conditions influence the plant–soil–microbes interaction in the tropics. Considering the significance of the subject, the present volume is designed to cover the most relevant aspects of rhizospheric microbial interactions in tropical ecosystems. Chapters include aspects related to the diversity of rhizospheric microbes, as well as modern tools and techniques to assess the rhizospheric microbiomes and their functional roles. The book also covers applications of rhizospheric microbes and evaluation of prospects improving agricultural practice and productivity through the use of microbiome technologies. This book will be extremely interesting to microbiologists, plant biologists, and ecologists.

Revenge - Cold Blooded

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Publisher : Clever Fox Publishing
ISBN 13 :
Total Pages : pages
Book Rating : 4./5 ( download)

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Book Synopsis Revenge - Cold Blooded by : Satish Chandra Verma

Download or read book Revenge - Cold Blooded written by Satish Chandra Verma and published by Clever Fox Publishing. This book was released on 2021-10-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The story revolves around a young charming girl “Gul” who is victim of a planned gang rape in Mumbai. She felt that justice would be delayed in court. Even she may not get justice. So Instead of making police complaint she decided to seek revenge herself with the help of her boy friend Ravi. Her condition for marriage was that he will have to help her in planning how to seek revenge? But revenge will be taken by her only. Ravi very smartly implants himself as a spy in enemy’s camp by getting friendly with her criminals. And their cold blooded revenge begins. A billion dollar question; whether she succeeded or failed? It’s a fiction (Thriller). Satish Chandra Verma.

Napoleon Hill: Adversity and Advantage

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Publisher : Sterling Publishing (NY)
ISBN 13 : 9781454944409
Total Pages : 256 pages
Book Rating : 4.9/5 (444 download)

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Book Synopsis Napoleon Hill: Adversity and Advantage by : Napoleon Hill

Download or read book Napoleon Hill: Adversity and Advantage written by Napoleon Hill and published by Sterling Publishing (NY). This book was released on 2021-09-07 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Generic Drug Product Development

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Publisher : CRC Press
ISBN 13 : 1420020021
Total Pages : 334 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Generic Drug Product Development by : Isadore Kanfer

Download or read book Generic Drug Product Development written by Isadore Kanfer and published by CRC Press. This book was released on 2016-04-19 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica

Drug Regulatory Affairs

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Publisher : Nirali Prakashan
ISBN 13 : 9789380064680
Total Pages : pages
Book Rating : 4.0/5 (646 download)

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Book Synopsis Drug Regulatory Affairs by : Dr Ns Vyawahare

Download or read book Drug Regulatory Affairs written by Dr Ns Vyawahare and published by Nirali Prakashan. This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affair and its Importance - Drug Discover and Development - Regulatory Strategy - Investigational New Drug Application IND - New Drug Application NDA - Abbreviated New Drug Application ANDA - Drug Master File DMF - Orphan Drug - Biological Licensing Application BLA - Registrationa of Drug Products in Overseas Markets Pharmaceutical export - Regulatory Authorities and Agencies - Overview of Drug and Cosmetic Act - Regulatory Guidelines - Useful Information

Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application

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Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application by :

Download or read book Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application written by and published by . This book was released on 1987 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:

FDA Regulatory Affairs

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Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)

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Book Synopsis FDA Regulatory Affairs by : David Mantus

Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Pharmaceutical Biotechnology

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Publisher : Springer
ISBN 13 : 9781461429241
Total Pages : 276 pages
Book Rating : 4.4/5 (292 download)

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Book Synopsis Pharmaceutical Biotechnology by : Carlos A. Guzmán

Download or read book Pharmaceutical Biotechnology written by Carlos A. Guzmán and published by Springer. This book was released on 2012-03-14 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Biotechnology is a unique compilation of reviews addressing frontiers in biologicals as a rich source for innovative medicines. This book fulfills the needs of a broad community of scientists interested in biologicals from diverse perspectives—basic research, biotechnology, protein engineering, protein delivery, medicines, pharmaceuticals and vaccinology. The diverse topics range from advanced biotechnologies aimed to introduce novel, potent engineered vaccines of unprecedented efficacy and safety for a wide scope of human diseases to natural products, small peptides and polypeptides engineered for discrete prophylaxis and therapeutic purposes. Modern biologicals promise to dramatically expand the scope of preventive medicine beyond the infectious disease arena into broad applications in immune and cancer treatment, as exemplified by anti-EGFR receptors antibodies for the treatment of breast cancer. The exponential growth in biologicals such as engineered proteins and vaccines has been boosted by unprecedented scientific breakthroughs made in the past decades culminating in an in-depth fundamental understanding of the scientific underpinnings of immune mechanisms together with knowledge of protein and peptide scaffolds that can be deliberately manipulated. This has in turn led to new strategies and processes. Deciphering the human, mammalian and numerous pathogens’ genomes provides opportunities that never before have been available—identification of discrete antigens (genomes and antigenomes) that lend themselves to considerably improved antigens and monoclonal antibodies, which with more sophisticated engineered adjuvants and agonists of pattern recognition receptors present in immune cells, deliver unprecedented safety and efficacy. Technological development such a nanobiotechnologies (dendrimers, nanobodies and fullerenes), biological particles (viral-like particles and bacterial ghosts) and innovative vectors (replication-competent attenuated, replication-incompetent recombinant and defective helper-dependent vectors) fulfill a broad range of cutting-edge research, drug discovery and delivery applications. Most recent examples of breakthrough biologicals include the human papilloma virus vaccine (HPV, prevention of women genital cancer) and the multivalent Pneumoccocal vaccines, which has virtually eradicated in some populations a most prevalent bacterial ear infection (i.e., otitis media). It is expected that in the years to come similar success will be obtained in the development of vaccines for diseases which still represent major threats for human health, such as AIDS, as well as for the generation of improved vaccines against diseases like pandemic flu for which vaccines are currently available. Furthermore, advances in comparative immunology and innate immunity revealed opportunities for innovative strategies for ever smaller biologicals and vaccines derived from species such as llama and sharks, which carry tremendous potential for innovative biologicals already in development stages in many pharmaceutical companies. Such recent discoveries and knowledge exploitations hold the promise for breakthrough biologicals, with the coming decade. Finally, this book caters to individuals not directly engaged in the pharmaceutical drug discovery process via a chapter outlining discovery, preclinical development, clinical development and translational medicine issues that are critical the drug development process. The authors and editors hope that this compilation of reviews will help readers rapidly and completely update knowledge and understanding of the frontiers in pharmaceutical biotechnologies.

Forensic Pharmacy

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Publisher : Editora Record
ISBN 13 : 9788185790015
Total Pages : 500 pages
Book Rating : 4.7/5 (9 download)

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Book Synopsis Forensic Pharmacy by : Dr. B. S. Kuchekar

Download or read book Forensic Pharmacy written by Dr. B. S. Kuchekar and published by Editora Record. This book was released on 2006-08 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Seed Endophytes

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Publisher : Springer
ISBN 13 : 3030105040
Total Pages : 497 pages
Book Rating : 4.0/5 (31 download)

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Book Synopsis Seed Endophytes by : Satish Kumar Verma

Download or read book Seed Endophytes written by Satish Kumar Verma and published by Springer. This book was released on 2019-04-05 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the importance and roles of seed microbiomes in sustainable agriculture by exploring the diversity of microbes vectored on and within seeds of both cultivated and non-cultivated plants. It provides essential insights into how seeds can be adapted to enhance microbiome vectoring, how damaged seed microbiomes can be assembled again and how seed microbiomes can be conserved. Plant seeds carry not only embryos and nutrients to fuel early seedling growth, but also microbes that modulate development, soil nutrient acquisition, and defense against pathogens and other stressors. Many of these microbes (bacteria and fungi) become endophytic, entering into the tissues of plants, and typically exist within plants without inducing negative effects. Although they have been reported in all plants examined to date, the extent to which plants rely on seed vectored microbiomes to enhance seedling competitiveness and survival is largely unappreciated. How microbes function to increase the fitness of seedlings is also little understood. The book is a unique and important resource for researchers and students in microbial ecology and biotechnology. Further, it appeals to applied academic and industrial agriculturists interested in increasing crop health and yield.

Pharmacognosy And Phytochemistry - I

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Publisher :
ISBN 13 : 9789351649717
Total Pages : 172 pages
Book Rating : 4.6/5 (497 download)

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Book Synopsis Pharmacognosy And Phytochemistry - I by : S B Gokhale

Download or read book Pharmacognosy And Phytochemistry - I written by S B Gokhale and published by . This book was released on 2016-06-16 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt: 1 Plant metabolites 2 Pharmacognostic scheme for study of natural drugs 3 Primary metabolites of pharmaceutical and industrial utility 4 Glycosides

The Bond King

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Publisher : Flatiron Books
ISBN 13 : 1250120853
Total Pages : 350 pages
Book Rating : 4.2/5 (51 download)

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Book Synopsis The Bond King by : Mary Childs

Download or read book The Bond King written by Mary Childs and published by Flatiron Books. This book was released on 2022-03-15 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the host of NPR’s Planet Money, the deeply-investigated story of how one visionary, dogged investor changed American finance forever. Before Bill Gross was known among investors as the Bond King, he was a gambler. In 1966, a fresh college grad, he went to Vegas armed with his net worth ($200) and a knack for counting cards. $10,000 and countless casino bans later, he was hooked: so he enrolled in business school. The Bond King is the story of how that whiz kid made American finance his casino. Over the course of decades, Bill Gross turned the sleepy bond market into a destabilized game of high risk, high reward; founded Pimco, one of today’s most powerful, secretive, and cutthroat investment firms; helped to reshape our financial system in the aftermath of the Great Recession—to his own advantage; and gained legions of admirers, and enemies, along the way. Like every American antihero, his ambition would also be his undoing. To understand the winners and losers of today’s money game, journalist Mary Childs argues, is to understand the bond market—and to understand the bond market is to understand the Bond King.

FDA Investigations Operations Manual

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Publisher :
ISBN 13 : 9780865879737
Total Pages : 0 pages
Book Rating : 4.8/5 (797 download)

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Book Synopsis FDA Investigations Operations Manual by : Food and Drug Administration

Download or read book FDA Investigations Operations Manual written by Food and Drug Administration and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.

New Drug Approval

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Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781984134349
Total Pages : 72 pages
Book Rating : 4.1/5 (343 download)

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Book Synopsis New Drug Approval by : United States Government Accountability Office

Download or read book New Drug Approval written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2018-02-02 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: New Drug Approval: FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints