
Botanical Drug Products
Botanical Drug Development
Â
FDA Guidance for Industry :
Botanical Drug Development
Â
Investigational New Drug Applications (IND’s)
References
References
Content and Format of IND’s for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products
References
References
INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information
References
References
Investigational New Drug Applications (INDs)- Determining Whether Human Research Studies can be Conducted Without an IND
References
References
FDA Guidance for Industry: Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
Â
New Drug Applications (NDA’s)
References
References
FDA Guidance for Industry: Formatting, Assembling and Submitting New Drug and Antibiotic Applications (1997)
References
References
FDA Guidance for Industry: Format and Content of the Microbiology Section of an Application
References
References
FDA Guidance for Industry: Format and Content of the Clinical and Statistical Sections of an Application
References
References
FDA Guidance for Industry: Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application
References
References
FDA Guidance for Industry: Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application
References
References
FDA Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products
References
References
FDA Guidance for Industry: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs and General Considerations
Orphan Drug Designation
Â
Â
Chemistry Manufacturing and Controls (CMC)
References
References
FDA Guidance for Industry: Process Validation: General Principles and Practices
References
References
FDA Guidance for Industry: INDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information
References
References
FDA Guidance for Industry:
Analytical Procedures and Methods Validation for Drugs and Biologics; Guidance for Industry
References
References
ICH: Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
Â
Good Manufacturing Practices (21 CFR 211)
References
References
FDA Guidance for Industry: WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
FDA Guidance for Industry: Guideline on the Preparation of Investigational New Drug Products
FDA Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs
FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements
FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
References
References
International Council for Harmonisation (ICH)
​ICH: Q7- Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
References
References
International Council for Harmonisation (ICH)
ICH: Q8(R2) Pharmaceutical Development
References
References
International Council for Harmonisation (ICH)
ICH: Q10 Pharmaceutical Quality System
Â