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Buku Buku 1 - 10 tentang 13 di ... changes: chemistry, manufacturing and controls, in vitro dissolution testing....
" ... changes: chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation... "
Statistical Design and Analysis of Stability Studies - Halaman 320
oleh Shein-Chung Chow - 2007 - 349 halaman
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Handbook of Pharmaceutical Granulation Technology

Dilip M. Parikh - 1997 - 528 halaman
...single-pot process using microwave/vacuum drying. Pharm Technol 18:44-60, 1994. 18. FDA, Immediate release solid oral dosage forms: scale-up and postapproval...manufacturing, and controls; in vitro dissolution testing; in vivo bioequivalence documentation; guidance. Fed Reg 60:61638—61643, 1995. 19. IR Berry, RA Nash,...
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GMP Compliance, Productivity, and Quality: Achieving Synergy in Healthcare ...

Vinay Bhatt - 1998 - 524 halaman
...Drug Administration, Center for Drug Evaluation and Research, May 1997. 3. Guidance for Industry — Modified Release, Solid Oral Dosage Forms, Scale-Up...Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing; and In Vivo Bioequivalence Documentation. US Department of Health and Human Services,...
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Design and Analysis of Bioavailability and Bioequivalence Studies, Second ...

Shein-Chung Chow, Jen-pei Liu - 1999 - 600 halaman
...Bioequivalence Studies Using a Standard Two -Treatment Crossover Design (July 1992); (c) Guidance on Immediate Release Solid Oral Dosage Forms; Scale-up and Postapproval...Manufacturing, and Controls; In Vitro Dissolution Testing; In Vivo Bioequivalence Documentation (SUPAC; November 1995); and (d) Draft Guidance on In Vivo Bioequivalence...
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Handbook of Modern Pharmaceutical Analysis

Satinder Ahuja, Stephen Scypinski - 2001 - 566 halaman
...Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (issued January 1999). SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up...Dissolution Testing and In Vivo Bioequivalence Documentation (issued October 1997). SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and PostApproval Changes:...
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Handbook of Modern Pharmaceutical Analysis

Satinder Ahuja, Stephen Scypinski - 2001 - 566 halaman
...Dissolution Testing and In Vivo Bioequivalence Documentation, November 1995 • Nonsterile Semisolid Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation, May 1997 • Changes to an Approved Application...
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Statistics in Drug Research: Methodologies and Recent Developments

Shein-Chung Chow, Jun Shao - 2002 - 384 halaman
...Bioequivaience Documentation, US Food and Drug Administration, Rockville, Maryland. SUPAC-MR (1997). Guidance on Modified Release Solid Oral Dosage Forms, Scale-up...and Controls, In Vitro Dissolution Testing, and In V,vo Bioequivalence Documentation, US Food and Drug Administration, Rockville, Maryland. SUPAC-SS (1997)....
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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Carmen Medina - 2003 - 704 halaman
...Research (CDER). Guidance for Industry. SUPAC IR-ImmediateRelease Solid Oral Dosage Forms: Scale- Up and Post-Approval Changes: Chemistry, Manufacturing...Testing, and in Vivo Bioequivalence Documentation, Nov. 30, 1995. Center for Drug Evaluation and Research (CDER). Guidance for Industry. SUPAC IR/MR:...
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Modified-Release Drug Delivery Technology

Michael J. Rathbone, Jonathan Hadgraft, Michael S. Roberts - 2002 - 1032 halaman
...change for both extended- and delayedrelease formulations. Where the "Guidance for Industry SUP AC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up...Post-approval changes: Chemistry, Manufacturing, and Controls, Invitro Dissolution Testing, and Invivo Bioequivalence Documentation" [14] recommends a biostudy, biowaivers...
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Applications of Pharmacokinetic Principles in Drug Development: Principles ...

Rajesh Krishna - 2004 - 550 halaman
...testing ofimmediate release solid oral dosage forms. 1997. 5. FDA Guidance for industry. SUPAC-MR : modified release solid oral dosage forms. Scale-up...testing, and in vivo bioequivalence documentation. 1997. 6 FDA Guidance for industry. Nonsterile semisolid dosage forms. Scale-up and postapproval changes...
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Pharmacokinetics in Drug Development: Regulatory and Development ..., Volume 2

Peter L. Bonate, Danny R. Howard - 2005 - 488 halaman
...Tech Today 2000; 3:417-425 Food and Drug Administration. Guidance for Industry: Nonsterile Semisolid Dosage Forms, Scale-up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation. US Department of Health and Human Services,...
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