Search results with tag "Multisource"
STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
www.who.int151 a multisource (generic) finished pharmaceutical product: quality part (4) 152 and the WHO Guidelines on submission of documentation for a 153 multisource (generic) finished pharmaceutical product for the WHO 154 Prequalification of Medicines Programme: quality part (5); and the 155 General guidance on hold time studies (6).
WHO Expert Committee on Specifications The International ...
www.who.intGuidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities. WHO Technical Report Series 992 Forty-ninth report WHO Expert Committee on Specifications for Pharmaceutical
Stability Studies - WHO
www.who.int(API) or Finished Pharmaceutical Product (FPP) varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. The ... multisource (generic) finished pharmaceutical product (FPP) has been revised: Preparation of Product Dossiers (PDS) in Common Technical Document (CTD) format
Preferred Drug List (PDL) - UHCprovider.com
www.uhcprovider.comGENERIC SUBSTITUTION The PDL requires generic substitution on the majority of products when a generic equivalent is available. MAXIMUM ALLOWABLE COST PRICING The UnitedHealthcare Community Plan Maximum Allowable Cost (MAC) pricing list sets a ceiling price for the reimbursement of certain multisource prescription drugs.
Annex 10 - ICH
database.ich.orgfor a multisource (generic) finished pharmaceutical product for the WHO Prequalification of Medicines Programme: quality part4) and WHO guidelines (on the active pharmaceutical ingredient master file procedure (5). It is recommended that these …
ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …
asean.org- Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to establish Interchangeability (WHO) - Guideline on Bioanalytical Method Validation (EMEA/CHMP/EWP/ 192217/2009 The guideline should also be read in conjunction with relevant guidelines on pharmaceutical quality.
GUIDELINE ON SUBMISSION OF …
www.pharmalytik.comworking document qas/10.373/rev.1 restricted 1 2 3 4 5 guideline on submission of documentation for a 6 multisource (generic) finished pharmaceutical 7 …
DRAFT PHARMACEUTICAL DEVELOPMENT FOR …
www.who.intWorking document QAS/08.251 January 2008 RESTRICTED DRAFT PHARMACEUTICAL DEVELOPMENT FOR MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS This draft is based on the concept paper QSM/EC/07.29 “Guideline for pharmaceutical
MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: …
www.who.intWorking document QAS/14.583/Rev.1 page 3 43 BACKGROUND 44 Over the course of time and especially in view of the implementation of the existing 45 guidelines 1 the users have indicated that there was a need to review and update certain 46 requirements.
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