Author: Safaraz K. Niazi
Publisher: CRC Press
ISBN: 1420081314
Category : Medical
Languages : en
Pages : 458
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Book Description
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster
Author: Safaraz K. Niazi
Publisher:
ISBN: 9781032931302
Category : Medical
Languages : en
Pages : 0
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Book Description
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products. With the increasing number of potent products joining the long list of proven sterile products, the technology of manufacturing these products has evolved into a very sophisticated industry. Highlights of
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1420048457
Category : Medical
Languages : en
Pages : 258
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Book Description
The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1351592238
Category : Medical
Languages : en
Pages : 453
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Book Description
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent. Features: Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines
Author: Sarfaraz K. Niazi
Publisher: CRC Press
ISBN: 1351594907
Category : Medical
Languages : en
Pages : 816
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Book Description
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
Author: Sarfaraz K. Niazi
Publisher:
ISBN: 9781032931296
Category : Medical
Languages : en
Pages : 0
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Book Description
Compressed solids are the largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms. They present some of the greatest challenges to formulation scientists. The first volume in the Handbook of Pharmaceutical Manufacturing Formulations discusses formulations for more than 200 of the most widely used
Author: Yihong Qiu
Publisher: Academic Press
ISBN: 008093272X
Category : Medical
Languages : en
Pages : 976
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Book Description
Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: - Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms - Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies - New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development - The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards - It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter - A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies
Author: Dilip M. Parikh
Publisher: CRC Press
ISBN: 1000366383
Category : Medical
Languages : en
Pages : 905
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Book Description
Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies
Author: Mark G. Papich
Publisher: Elsevier Health Sciences
ISBN: 0323709583
Category : Medical
Languages : en
Pages : 1060
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Book Description
**Selected for Doody's Core Titles® 2024 in Veterinary Medicine** Papich Handbook of Veterinary Drugs, 5th Edition includes concise entries for more than 550 drugs, with appendices summarizing clinically relevant information at a glance. Nineteen new drug monographs are added to this edition, and over 100 drug monographs have been updated and revised. An Expert Consult website contains more than 150 instructional handouts that may be customized and printed out for your clients. Written by clinical pharmacology expert Mark Papich, this handy reference makes it easy to find the drug data and dosage recommendations you need to treat small and large animals, right when you need it! - Over 550 concise drug monographs are organized alphabetically and cross-referenced by classification, trade, and generic name, providing quick and easy access to key information for each drug including:• Generic and trade names, pronunciation, and functional classification • Pharmacology and mechanism of action • Indications and clinical uses • Precautionary information — adverse reactions and side effects, contraindications and precautions, and drug interactions — all featured in colored boxes for at-a-glance retrieval • Instructions for use • Patient monitoring and laboratory tests • Formulations available • Stability and storage • Dosage information for both small and large animals • Regulatory information - Clinically relevant appendices help you determine appropriate therapeutic regimens and look up safety and legal considerations. - NEW! 19 new drug monographs familiarize you with the latest drugs available for veterinary practice. - UPDATED drug monographs include new information such as changes in doses, interactions, indications, adverse reactions, and contraindications. - NEW! Expert Consult companion website replaces the former website and includes more than 150 customizable client information handouts for commonly prescribed drugs, including information on the prescribed drug and dosage, do's and don'ts, and possible side effects. - NEW! Removal of entries for drugs that have been taken off the market.
Author: Reynir Eyjolfsson
Publisher: Academic Press
ISBN: 012802187X
Category : Medical
Languages : en
Pages : 68
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Book Description
Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book. - Incorporates important mathematical models and computational applications - Includes unique content on central composite design and augmented simplex lattice - Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms
