Items related to Generic Drug Product Development: Bioequivalence Issues...
Generic Drug Product Development: Bioequivalence Issues (Drugs and the Pharmaceutical Sciences, 180) - Hardcover
Synopsis
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.
"synopsis" may belong to another edition of this title.
About the Author
Isadore Kanfer, Leon Shargel
"About this title" may belong to another edition of this title.
Other Popular Editions of the Same Title
Search results for Generic Drug Product Development: Bioequivalence Issues...
International Edition
GENERIC DRUG PRODUCT DEVELOPMENT: BIOEQUIVALENCE ISSUES, DPSS. 180
International EditionSeller: Basi6 International, Irving, TX, U.S.A.
Seller rating 5 out of 5 stars
Condition: Brand New. New.SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. Seller Inventory # ABEJUNE24-413002
Quantity: 1 available
International Edition
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
International EditionSeller: Basi6 International, Irving, TX, U.S.A.
Seller rating 5 out of 5 stars
Condition: Brand New. New.SoftCover International edition. Different ISBN and Cover image but contents are same as US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service. Seller Inventory # ABEJUNE24-401395
Quantity: Over 20 available
International Edition
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
International EditionSeller: Romtrade Corp., STERLING HEIGHTS, MI, U.S.A.
Seller rating 5 out of 5 stars
Condition: New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide. Seller Inventory # ABNR-68348
Quantity: 5 available
Stock Image
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
Seller: SMASS Sellers, IRVING, TX, U.S.A.
Seller rating 5 out of 5 stars
Condition: New. Brand New, Softcover edition. This item may ship from the US or our Overseas warehouse depending on your location and stock availability. Seller Inventory # ASNT3-68348
Quantity: 5 available
International Edition
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
International EditionSeller: UK BOOKS STORE, London, LONDO, United Kingdom
Seller rating 5 out of 5 stars
Condition: New. Brand New! Fast Delivery This is an International Edition and ship within 24-48 hours. Deliver by FedEx and Dhl, & Aramex, UPS, & USPS and we do accept APO and PO BOX Addresses. Order can be delivered worldwide within 7-10 days and we do have flat rate for up to 2LB. Extra shipping charges will be requested if the Book weight is more than 5 LB. This Item May be shipped from India, United states & United Kingdom. Depending on your location and availability. Seller Inventory # CvS 9780849377846
Quantity: Over 20 available
International Edition
GENERIC DRUG PRODUCT DEVELOPMENT BIOEQUIVALENCE ISSUES, VOL 180
International EditionSeller: URW Books Store, CASPER, WY, U.S.A.
Seller rating 5 out of 5 stars
Condition: Brand New. Brand New! . "This is an International Edition." Book is In New condition and ship within One Working Day Tracking Number Provided by Customer 12-24 In To Hour, Deliver by FedEx & Aramex, UPS, & USPS Act. Order can be delivered worldwide With In 7-10 Working day Delivery. Ship from India & United States. Seller Inventory # CBSBOOKS26320
Quantity: Over 20 available
Seller Image
Generic Drug Product Development : Bioequivalence Issues
Seller: GreatBookPrices, Columbia, MD, U.S.A.
Seller rating 5 out of 5 stars
Condition: New. Seller Inventory # 5117727-n
Quantity: 1 available
Stock Image
Generic Drug Product Development
Seller: PBShop.store US, Wood Dale, IL, U.S.A.
Seller rating 5 out of 5 stars
HRD. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # FT-9780849377846
Quantity: 1 available
Stock Image
Generic Drug Product Development
Seller: PBShop.store UK, Fairford, GLOS, United Kingdom
Seller rating 5 out of 5 stars
HRD. Condition: New. New Book. Shipped from UK. Established seller since 2000. Seller Inventory # FT-9780849377846
Quantity: 1 available
Seller Image
Generic Drug Product Development : Bioequivalence Issues
Seller: GreatBookPricesUK, Woodford Green, United Kingdom
Seller rating 5 out of 5 stars
Condition: As New. Unread book in perfect condition. Seller Inventory # 5117727
Quantity: 1 available