Untitled design (1).png

Botanical Drug Products

Botanical Drug Development

 

FDA Guidance for Industry :

Botanical Drug Development

 

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

Exploratory IND Studies

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

 

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

 

References

References

FDA: Clarification of Orphan Drug Designation of Drugs and Biologics for Pediatrics 

References

References

FDA: Meetings with the Office of Orphan Products Development

References

References

FDA: Rare Diseases: Common Issues in Drug Development

 

Chemistry Manufacturing and Controls (CMC)

References

References

FDA Guidance for Industry: Process Validation: General Principles and Practices

References

References

FDA Guidance for Industry: Submission of Quality Metrics Data

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: Q1A (R2) STability Testing of New Drug Substances and Products

References

References

ICH: Q1E Evaluation of Stability Data

References

References

ICH: Q2(R1)  Analytical Validation

References

References

ICH: Q3A (R2) Impurities in New Drug Substances

References

References

ICH: Q3B(R2) Impurities in New Drug Products

References

References

ICH: Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

References

References

ICH: Q8(R2) Pharmaceutical Development

 

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

 

Clinical Trials

References

References

FDA Guidance for Industry: Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

References

References

FDA Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics

References

References

FDA Guidance for Industry: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics

References

References

FDA Guidance for Industry: Meta-Analysis of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products

References

References

FDA Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers

References

References

FDA Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials

References

References

FDA Guidance for Industry: Establishment and Operation of Clinical Trial Data Monitoring Committees

References

References

ICH: E3 Clinical Study Reports

References

References

ICH: E6(R2) Good Clinical Practice

References

References

ICH: E8 General Considerations for Clinical Trials

References

References

ICH: E9(R1) Statistical Principles for Clinical Trials

References

References

ICH: E10 Choice of Control Group and Related Issues in Clinical Trials

References

References

ICH: E17 General Principles for Planning and Designing Multi-Regional Clinical Trials

References

References

ICH: E19 Safety Data Collection

© 2021 BRC powered by coally