INTRO
DISCLAIMER
CONSULT EXPERTISE
PROJECT MANAGEMENT
COMMISSIONING, QUALIFICATION & VALIDATION
QUALITY MANAGEMENT SYSTEMS
REGULATORY COMPLIANCE
GMP DISCUSSION
GMP INSIGHTS
BLOG
SME VOICE
ABOUT GMP
WHAT IS GMP?
GUIDELINES SOURCES
USFDA TOPIC GUIDANCES
>
CDER
CBER
GENERICS
BIOPHARMACEUTICS
GMP INSPECTIONS
483 AND WARNING LETTERS
GMP GLOSSARY
A
B
C
D
E
F
G
H
I
K
L
M
N
O
P
Q
R
S
T
U
V
W, Y & Z
Biopharmaceutics Guidances
Bioanalytical Method Validation (PDF - 63KB)
Final Guidance, (05/01/01)
Bioanalytical Method Validation [Revised Final] (PDF - 526KB)
Draft Guidance, (09/12/13)
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (PDF - 727KB)
Draft Guidance, (04/03/03)
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999 (PDF - 191KB)
Draft Guidance, (04/11/03)
Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (PDF - 2.6MB)
Final Guidance, (06/02/95)
Dissolution Testing of Immediate Release Solid Oral Dosage Forms (PDF - 130KB)
Final Guidance, (08/01/97)
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (PDF - 170KB)
Final Guidance, (09/01/97)
Food-Effect Bioavailability and Fed Bioequivalence Studies (PDF - 217KB)
Final Guidance, (12/01/02)
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (PDF - 744KB)
Final Guidance, (06/27/89)
Statistical Approaches to Establishing Bioequivalence (PDF - 130KB)
Final Guidance, (02/01/01)
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. (PDF - 141KB)
Draft Guidance, (05/05/15)
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (PDF - 128KB)
Draft Guidance, (12/04/13)
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (PDF - 805KB)
Draft Guidance, (03/17/14)
Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry (PDF - 87KB)
Draft Guidance, (07/31/15)
Get in Touch With Me
*
Indicates required field
Enter Your Name
*
First
Last
Enter Your Email *
*
Enter Your Message
*
Submit
MD. Saddam Nawaz
INTRO
DISCLAIMER
CONSULT EXPERTISE
PROJECT MANAGEMENT
COMMISSIONING, QUALIFICATION & VALIDATION
QUALITY MANAGEMENT SYSTEMS
REGULATORY COMPLIANCE
GMP DISCUSSION
GMP INSIGHTS
BLOG
SME VOICE
ABOUT GMP
WHAT IS GMP?
GUIDELINES SOURCES
USFDA TOPIC GUIDANCES
>
CDER
CBER
GENERICS
BIOPHARMACEUTICS
GMP INSPECTIONS
483 AND WARNING LETTERS
GMP GLOSSARY
A
B
C
D
E
F
G
H
I
K
L
M
N
O
P
Q
R
S
T
U
V
W, Y & Z