Rathbone Modified Release Drug

Delivery Technology 2Ed

Rathbone Modified Release Drug Delivery
Technology 2Ed
Rathbone Modified Release Drug Delivery
Technology 2Ed
Rathbone Modified Release Drug Delivery
Technology 2Ed
GUIDELINE FOR DRUG MASTER FILES
September 1989
TABLE OF CONTENTS
1. Types of Drug Master Files

I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
A. Transmittal Letters
1. Original Submissions
2. Amendments
B. Administrative Information
1. Original Submissions
2. Amendments
C. Drug Master File Contents
I. INTRODUCTION
II. DEFINITIONS
III. TYPES OF DRUG MASTER FILES
IV. SUBMISSIONS TO DRUG MASTER FILES
A. Transmittal Letters
1. Original Submissions
2. Amendments

B. Administrative Information
1. Original Submissions
2. Amendments
C. Drug Master File Contents