Advanceutics Inc.
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Links to Useful Resources
- Drug Development Terminology.
- Patent Search: US PTO and Google Patents.
- Chemistry, Manufacturing, and Controls (CMC) Guidelines from USFDA
- Inactive Ingredient (Excipient Information @ USFDA).
- USFDA Recommended Dissolution Methods.
- USFDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
- USFDA Approved Drug Product Data Base (Drugs @ FDA).
- USFDA Format and Content for the CMC Section of an Annual Report.
- USFDA Guidelines Related to Post Approval Changes:
- CMC Post Approval Mfg Changes Reportable as Annual Reports.
- Changes to Approved NDA and ANDA.
- Changes to Approved NDA and ANDA with Q&A.
- Scale-Up and Postapproval Changes (SUPAC): Immediate Release Solid Oral Dosage Forms (IR).
- SUPAC-MR (Modified Release Solid Oral Dosage Forms).
- SUPAC-IR/MR: Manufacturing Equipment Addendum.
- Regulatory and Procedural Guidance for Human Drugs by EMA
- Variation Filing in EU
- ICH Guidance
- Stability
- Impurities in Drug Product.
- Specifications for Drug Substances and Drug Products with Decision Trees.
- Pharmaceutical Development.
- USFDA Guideline(Draft) on Blend Uniformity Analysis with Stratified Nested Sampling and Decision Trees.
- USFDA Guideline on Process Validation: General Principles and Practices
- USFDA Guideline on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation
- USFDA Guideline on Investigational New Drug Applications (IND).