Handbook of Pharmaceutical Manufacturing Formulations Compressed Solid Products 3rd Edition by Sarfaraz Niazi 1351594905 9781351594905

Handbook of Pharmaceutical Manufacturing Formulations Compressed Solid Products 3rd Edition by Sarfaraz K. Niazi  – Ebook PDF Instant Download/DeliveryISBN: 1351594905, 9781351594905

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ISBN-10 :  1351594905 

ISBN-13 :  9781351594905

Author:  Sarfaraz K. Niazi 

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.

Handbook of Pharmaceutical Manufacturing Formulations Compressed Solid Products 3rd table of contents:

PART I Regulatory and Manufacturing Considerations
Chapter 1 Bioequivalence Testing: Rationale and Principles
I. Background
II. Evidence to Measure Bioequivalence
III. Pivotal Parameters for Blood-Level Bioequivalence
A. Area under the Curve Estimates
IV. Rate of Absorption
V. Determination of Product Bioequivalence
VI. Errors in Bioequivalence Studies
VII. Absorption Profiling
VIII. Pharmacokinetic Measures of Systemic Exposure
A. Early Exposure
B. Peak Exposure
C. Total Exposure
IX. Statistical Analysis
X. Untransformed Data
XI. Logarithmically Transformed Data
Bibliography
Appendix: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations
I. Introduction
II. Background
III. Methods to Document BA And BE
IV. Documenting BA And BE For Various Dosage Forms
V. Additional Information on in Vitro Approaches
VI. Special Topics
Appendix A: General Study Design and Data Handling
Chapter 2 Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System: Guidance for Industry
I. Introduction
II. The Biopharmaceutics Classification System
A. Solubility
B. Permeability
C. Dissolution
III. Recommended Methodology for Classifying a Drug Substance and for Determining the Dissolution Characteristics Of a Drug Product
A. Determining Drug Substance Solubility Class
B. Determining Drug Substance Permeability Class
C. Determining Drug Product Dissolution Characteristics and Dissolution Profile Similarity
IV. Biowaivers Based on Bcs
V. Additional Considerations for Requesting A Biowaiver
A. Excipients
B. Prodrugs
C. Fixed Dose Combinations Containing BCS Class 1, or Class 3, or a Combination of Class 1 and 3 Drugs
D. Exceptions
VI. Regulatory Applications of the Bcs–Based Biowaivers
A. INDs/NDAs
B. ANDAs
C. Supplemental NDAs/ANDAs (Postapproval Changes)
VII. Data to Support a Biowaiver Request
A. Data Supporting High Solubility
B. Data Supporting High Permeability
C. Data Supporting Rapid, Very Rapid, and Similar Dissolution
D. Additional Information
Attachment A
Chapter 3 Product-Specific Guidance from FDA on the Development of Compressed Dosage Forms
Chapter 4 Guidance on Formulating Compressed Solids
Background
Tablet Types
Formulation Factors
I. Active Pharmaceutical Ingredient
II. Bio Versus Production Batches
III. Cleaning Validation
IV. Coatings
V. Compliance with Regulatory Requirements
VI. Compression Process Control
VII. Content Uniformity
VIII. Cross-Contamination
IX. Desegregation of Powders
X. Disintegration Test
A. Uncoated Tablets
B. Plain Coated Tablets
C. Delayed-Release (Enteric-Coated) Tablets
D. Buccal Tablets
E. Sublingual Tablets
XI. Dissolution
XII. Disintegration and Dissolution
XIII. Drug Substance Characterization
XIV. Drying Process
XV. Dyes in Formulations
XVI. Equipment
A. Blenders
B. Dryers
C. Tablet Compression Equipment
D. Coating Equipment
XVII. Excipients
A. Coating Agent
B. Glidant
C. Tablet Binder
D. Diluent
E. Disintegrant
F. Lubricant
XVIII. Direct Compression
XIX. Fill Weights
XX. Final Packaging
XXI. Final Testing
XXII. Fines
XXIII. Formula Excesses
XXIV. Geometric Dilution
XXV. Granulation/Mix Analysis
XXVI. Ingredient Warning
XXVII. In-Process Testing
XXVIII. Loss on Drying
XXIX. Manufacturing Yields
XXX. Master Formula
XXXI. Multiple-Item Entries
XXXII. Multiple Strengths of Formulations
XXXIII. Novel Drug Delivery Systems
XXXIV. Particle Coating
XXXV. Preservatives in Compressed Solid Dosage Formulations
XXXVI. Punch Size and Shape
XXXVII. Reworking Culls
XXXVIII. Scale-Up
XXXIX. Segregation
XL. Sifting Ingredients and Granules
XLI. Specifications
XLII. Stability Testing
XLIII. Storage of In-Process Material
XLIV. Tablet Friability
XLV. Tablet Manufacturing
XLVI. Tablets
XLVII. Water-Purified Usp
XLVIII. Weight Variation and Content Uniformity
XLIX. Wet Granulation versus Dry Granulation or Direct Compression
L. Multivariate Methods in Tablet Formulation
LI. Physical Properties
LII. Particle Size Studies
A. Particle Size Distribution
LIII. Surface Area
LIV. Porosity
LV. True Density
LVI. Flow and Compaction of Powders
LVII. Color
LVIII. Electrostaticity
LIX. Caking
LX. Polymorphism
LXI. Stability Studies to Select Optimal Drug And Excipient Combinations

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