Handbook of Pharmaceutical Manufacturing Formulations, Second Edition: (Six-Volume Set)

Overview

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and ...

See more details below
Available through our Marketplace sellers.
Other sellers (Hardcover)
  • All (2) from $836.64   
  • New (1) from $836.64   
  • Used (1) from $1,250.04   
Close
Sort by
Page 1 of 1
Showing All
Note: Marketplace items are not eligible for any BN.com coupons and promotions
$836.64
Seller since 2015

Feedback rating:

(0)

Condition:

New — never opened or used in original packaging.

Like New — packaging may have been opened. A "Like New" item is suitable to give as a gift.

Very Good — may have minor signs of wear on packaging but item works perfectly and has no damage.

Good — item is in good condition but packaging may have signs of shelf wear/aging or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Acceptable — item is in working order but may show signs of wear such as scratches or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Used — An item that has been opened and may show signs of wear. All specific defects should be noted in the Comments section associated with each item.

Refurbished — A used item that has been renewed or updated and verified to be in proper working condition. Not necessarily completed by the original manufacturer.

New
"New, Excellent customer service. Satisfaction guaranteed!! "

Ships from: Irving, TX

Usually ships in 1-2 business days

  • Canadian
  • Standard, 48 States
Page 1 of 1
Showing All
Close
Sort by
Sending request ...

Overview

An authoritative and practical guide to the art and science of formulating drugs.

With thoroughly revised and expanded content, this Second Edition six-volume set compiles volumes from FDA New Drug Applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of issues concerning drug manufacturing.

A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this set is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

As the largest reference on pharmaceutical formulations, this handbook also provides guidelines on how to file aNDAs in the shortest possible time, helping pharmaceutical companies to cut costs in the areas of pharmaceutical research and development.

Divided conveniently into two parts—regulatory and manufacturing guidelines, and formulations—each volume in the set covers:

  • cGMP compliance
  • pre-approval inspections
  • stability and bioequivalence testing
  • packaging commodity development
  • common difficulties in formulating drugs
  • changes to aNDAs
Read More Show Less

Product Details

  • ISBN-13: 9781420081060
  • Publisher: Taylor & Francis
  • Publication date: 9/21/2009
  • Edition number: 2
  • Pages: 2094
  • Product dimensions: 0.85 (w) x 1.10 (h) x 9.40 (d)

Table of Contents

Volume I: Bioequivalence Testing Rationale and Principles. Bioequivalence Testing Protocols-FDA-Compressed Dosage Forms. GMP Audit Template, EU Guidelines. Guidance on Formulating Compressed Solids. Appendix I: Dissolution Testing Requirements of Compressed Dosage Forms. Appendix II: Approved Excipients in Compressed Solid Dosage Forms.

Volume II: Regulatory and Manufacturing Guidelines. US FDA Good Manufacturing Practices. GMP Audit Template, EU Guidelines. Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use. Process Validation: General Principles and Practices. Process Validation: General Principles and Practices. Bioequivalence Regulatory Review Process and Audit. EU Guidelines to Good Manufacturing Practice Basic Requirements for Active Substances used as Starting Materials. Preapproval Inspections. Formulation Factors in Uncompressed Dosage Forms. Dissolution Testing of Uncompressed Solid Dosage Forms. Approved Excipients in Uncompressed Solid Dosage Forms. Uncompressed Solids Formulations.

Volume III: Regulatory and Manufacturing Guidance. Manufacturing Practice Considerations in Liquid Formulations. Oral Solutions and Suspensions. The FDA Drug Product Surveillance Program. Changes to Approved NDAs and aNDAs. Formulation Considerations of Liquid Products. Container Closure Systems. Container Closure Systems. Stability Testing of New Drug Substances and Products. Stability Testing: Photostability Testing of New Drug Substances and Products. Stability Testing for New Dosage Forms. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. Evaluations of Stability Data. Stability Data Package for Registration Applications in Climatic Zones III and IV. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. EDQM Certification. Impurities: Guideline For Residual Solvents. Electronic Records and Signatures [CFR 21 Part 11 Compliance]. GMP Audit Template, EU Guidelines. Bioequivalence Testing Protocols. Dissolution Testing of Liquid Dosage Forms. Approved Excipients in Liquid Forms. Manufacturing Formulations.

Volume IV: Regulatory and Manufacturing Guidance. Waiver of In Vivo Bioequivalence Study. Quality Risk Management. Pharmaceutical Quality System. Pharmaceutical Development. Pharmaceutical Development in Ctd. Scale-Up and Post-approval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Validation of Analytical Procedures. Good Manufacturing Requirements for Active Pharmaceutical Ingredients. FDA Active Pharmaceutical Ingredient Manufacturing Facility Inspection. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products. Impurities In New Drug Substances. Drug Products Impurities in New Drug Substances. Formulation Factors in Semisolid Dosage Forms. GMP Audit Template, EU Guidelines. Dissolution. Testing of Semisolid Dosage Forms. Approved Excipients in Semisolid Dosage Forms. Manufacturing Formulations.

Volume V: Regulatory Guidance. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. EDQM Certification. GMP Audit Template, EU Guidelines. WHO Good Manufacturing Guidelines. Quality management in the drug industry: philosophy and essential elements. Solid Oral Dosage Forms Validation. Current Regulatory Status of Over-the-Counter Products. Pharmaceutical Manufacturing Formulations. Tablet Coating Formulations.

Volume VI: Regulatory and Manufacturing. Sterile Manufacturing Formulations Template. GMP Audit Template, EU Guidelines. Inspection of Sterile Product Manufacturing Facilities. New Drug Application for Sterilized Products. Validation of Cleaning Process. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products. Stability Testing of Biotechnological/Biological Products. Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products. Comparability of Biotechnological / Biological Products Subject to Changes in Their Manufacturing Process. Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Essential Cleanroom Design Elements. Approved Excipients in Sterile Dosage Forms. Manufacturing Formulations.

Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star

(0)

4 Star

(0)

3 Star

(0)

2 Star

(0)

1 Star

(0)

Your Rating:

Your Name: Create a Pen Name or

Barnes & Noble.com Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & Noble.com that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & Noble.com does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at BN.com or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation

Reminder:

  • - By submitting a review, you grant to Barnes & Noble.com and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Noble.com Terms of Use.
  • - Barnes & Noble.com reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & Noble.com also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on BN.com. It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

 
Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)