Industry & Applied R&D

Pharmaceutical industry research

Pharmaceutical industry research runs on a regulated chain from nonclinical studies to marketing approval, and much of its practice is set by regulators and the ICH. Nonclinical laboratory studies that support FDA applications follow Good Laboratory Practice under 21 CFR Part 58. Before a new drug is tested in people in the United States, the sponsor files an Investigational New Drug application and must wait 30 calendar days before starting trials. The New Drug Application later carries the clinical and animal data, manufacturing and quality controls, and proposed labeling. Trials follow ICH E6(R3) Good Clinical Practice, issued as FDA guidance in September 2025, alongside ICH E8(R1) on general considerations for clinical studies and the E9(R1) estimand framework for statistics. Electronic records must meet 21 CFR Part 11, and FDA and PMDA list CDISC SDTM among their required data standards. In the EU, the Clinical Trials Regulation 536/2014 routes applications through CTIS, sponsors report suspected adverse reactions electronically to EudraVigilance, and Good Pharmacovigilance Practices bind marketing authorisation holders after approval. Applicable US trials must submit results to ClinicalTrials.gov within one year of the primary completion date, and platforms such as Vivli handle requests for participant-level trial data. DIA and its journal Therapeutic Innovation and Regulatory Science connect regulatory and development professionals across the field.

Reviewed 5 November 2026 by CASRAI Editorial Board

Sources

FDA: E6(R3) Good Clinical Practice guidance(read 5 November 2026)
FDA: E8(R1) General Considerations for Clinical Studies(read 5 November 2026)
FDA: E9(R1) estimands and sensitivity analysis addendum(read 5 November 2026)
21 CFR 11.1 (law.cornell.edu)(read 5 November 2026)
21 CFR 58.1 (law.cornell.edu)(read 5 November 2026)
42 CFR 11.44 (law.cornell.edu)(read 5 November 2026)
FDA: Investigational New Drug (IND) Application(read 5 November 2026)
FDA: New Drug Application (NDA)(read 5 November 2026)
EMA: Clinical Trials Regulation(read 5 November 2026)
EMA: Clinical Trials Information System(read 5 November 2026)
EMA: EudraVigilance(read 5 November 2026)
EMA: Good pharmacovigilance practices(read 5 November 2026)
CDISC: SDTM(read 5 November 2026)
Vivli: overview(read 5 November 2026)
medRxiv: about(read 5 November 2026)
WHO: ICTRP(read 5 November 2026)
DIA: about(read 5 November 2026)
DIA: Therapeutic Innovation and Regulatory Science(read 5 November 2026)

Field at a glance

Standards and formats

ICH E6(R3) Good Clinical Practice: The harmonised GCP standard, issued as final FDA guidance in September 2025, stressing quality by design and risk-based quality management.Website ↗ · Our guide →
ICH E9(R1) estimands addendum: FDA guidance (May 2021) setting a framework for defining the treatment effect a trial estimates and for sensitivity analysis.Website ↗ · Our guide →
21 CFR Part 11: FDA criteria under which electronic records and electronic signatures are treated as equivalent to paper records and handwritten signatures.Website ↗ · Our guide →
21 CFR Part 58 (GLP): Good Laboratory Practice for nonclinical laboratory studies supporting FDA applications, meant to protect the quality and integrity of safety data.Website ↗ · Our guide →
Investigational New Drug application (IND): The FDA filing needed before a new drug is tested in humans; the sponsor waits 30 calendar days before starting trials.Website ↗ · Our guide →
New Drug Application (NDA): The submission asking FDA to approve a new drug for US marketing, with clinical, nonclinical, manufacturing and labeling information.Website ↗ · Our guide →
CDISC SDTM: Study Data Tabulation Model, listed as a required standard for study data submitted to FDA and PMDA.Website ↗ · Our guide →
EU Good Pharmacovigilance Practices (GVP): EMA modules on pharmacovigilance systems, risk management, adverse reaction reporting and signal management for marketing authorisation holders.Website ↗ · Our guide →

Archives, facilities and data

ClinicalTrials.gov results submission (42 CFR Part 11): Results for applicable clinical trials are due no later than one year after the primary completion date.Website ↗ · Our guide →
Clinical Trials Information System (CTIS): EU platform where sponsors apply to run trials in up to 30 EEA countries with one application and record results.Website ↗ · Our guide →
EudraVigilance: EMA system for suspected adverse reaction reports; electronic reporting is obligatory for authorisation holders and trial sponsors.Website ↗ · Our guide →
Vivli: Independent non-profit platform for requesting and analysing individual participant-level data from completed clinical trials.Website ↗ · Our guide →

Preprints and indexes

medRxiv: Free preprint server for medicine, clinical research and health sciences, run by openRxiv; preprints are not peer reviewed.Website ↗ · Our guide →
WHO International Clinical Trials Registry Platform: WHO network of registries with a search portal across trial records, including ClinicalTrials.gov; it does not register trials itself.Website ↗ · Our guide →

Societies

DIA (Drug Information Association): Global multidisciplinary membership association for life science professionals working across drug, device and diagnostic development.Website ↗

Journals

Therapeutic Innovation and Regulatory Science: Peer-reviewed DIA journal covering health care products from discovery through development, regulation and use.Website ↗

92 pages across 12 topic areas

Clinical Research Administration

21 CFR: What Title 21 of the Code of Federal Regulations Covers
A routing guide to Title 21 of the Code of Federal Regulations: how CFR citations are structured, and which Part governs electronic records, informed…
BPOM Indonesia Clinical Trial Approval Process: Regulation No. 34 of 2025 Update
BPOM's clinical trial approval process under Regulation No. 8 of 2024, and what Regulation No. 34 of 2025's cosmetic-clinical-trial amendment does and…
Budget Impact Analysis: What It Is and How It Differs From Cost-Effectiveness Analysis
Budget impact analysis projects the net financial effect of a new intervention on a payer's budget over a defined time horizon -- affordability, not v…
CDISC Standards for FDA Submissions: SDTM, ADaM, SEND, and Define-XML
CDISC is the nonprofit standards development organization behind SDTM, ADaM, SEND and Define-XML. FDA requires those formats for study data in NDAs, B…
Clinical Data Management Certification: CCDA, CCDM, CCDS, and How They Compare to ACRP/SOCRA
How SCDM's CCDA/CCDM/CCDS clinical data management certification ladder works, and how it differs from ACRP (CCRC/CCRA) and SOCRA (CCRP) credentials.…
Clinical Data Management: Processes, Systems, and Standards
What clinical data management covers end-to-end -- EDC build and validation, edit checks, query resolution, source data verification, medical coding,…
Clinical Study Report Structure (ICH E3)
A section-by-section walkthrough of the ICH E3 Clinical Study Report template: the 16 numbered sections, the four appendix categories, the synopsis le…
Data Management Plan for Clinical Trials: EDC, CRF Flow, Lock & Retention
How a clinical trial DMP differs from a general research DMP: EDC system specification, CRF data flow, database lock procedure, source data verificati…
eCTD Structure for Clinical Submissions
How the eCTD five-module hierarchy is structured, what belongs in FDA's region-specific Module 1, current v3.2.2/v4.0 specification requirements, and…
EU HTA Regulation & Joint Clinical Assessment
What the EU HTA Regulation's Joint Clinical Assessment covers, its January 2025/2028/2030 phase-in by product category, JCA dossier requirements, and…
FDA Breakthrough Therapy Designation: Criteria and Process
How FDA Breakthrough Therapy designation works: the serious-condition and preliminary-clinical-evidence criteria, what the designation confers (intens…
FDA Expedited Programs: Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review Compared
A landscape overview of FDA's four expedited programs -- Fast Track, Breakthrough Therapy designation, Accelerated Approval, and Priority Review -- ho…
FDA Purple Book: What It Lists and How to Search It
The FDA Purple Book lists licensed biological products, including biosimilar and interchangeable ones. How to search it and what its exclusivity dates…
Good Documentation Practices (GDP) in Clinical Trials
Good documentation practices (GDP) means applying the ALCOA/ALCOA+ data-integrity principles to clinical trial source documents, case report forms, an…
ICH E6 vs. ICH E8(R1): GCP Conduct vs. Quality-by-Design PlanningComparison
ICH E6 (Good Clinical Practice) governs how trials are conducted; ICH E8(R1) sets the quality-by-design framework used to plan them. How the two guide…
ICH E6(R3): What Changed in Good Clinical Practice
ICH E6(R3) restructures Good Clinical Practice into a Principles document plus Annexes, and shifts from prescriptive procedural rules to a risk-propor…
Mapping Clinical Data to the OMOP Common Data Model
The OMOP Common Data Model (OMOP CDM) is OHDSI's open standard for structuring observational health data - EHR records, insurance claims, registries -…
Markov Cohort Models in Cost-Effectiveness Analysis: States, Transitions, and the Cohort Trace
Markov cohort models move a hypothetical cohort through mutually exclusive health states over discrete cycles. This guide covers the core structure, t…
MedDRA Coding for Trial Safety Data
How MedDRA coding works: the five-level hierarchy (SOC, HLGT, HLT, PT, LLT), MSSO coding conventions, and how sponsors handle MedDRA version upgrades…
Medical Science Liaison: What the Role Is and How to Enter It
What a medical science liaison (MSL) does day to day, why the role is firewalled from sales, entry requirements, how a postdoc or clinical background…
Naranjo Algorithm for Adverse Drug Reactions: The Ten Questions, the Score Bands, and Its Documented Limits
A working walkthrough of the Naranjo ADR Probability Scale: what each of the ten items is actually asking, how the score bands are defined, what the p…
NDA, BLA, 505(b)(2), and ANDA: FDA Marketing Application Pathways ComparedComparison
NDA, 505(b)(2), BLA, and ANDA are FDA's four marketing-application pathways for drugs and biologics. A side-by-side comparison of statutory basis, dat…
Orphan Drug Designation: FDA Criteria, Process, and Incentives
A practical explainer on FDA orphan drug designation: the prevalence and scientific-rationale criteria, how sponsors apply through the Office of Orpha…
Pharmaceutical CRO Industry: A Sector Overview
A sector-level overview of the pharmaceutical CRO industry: market structure and tiers, why sponsors outsource, typical service lines, and how sponsor…
Pharmacovigilance Certification: What It Is and Which Program Fits
No single required PV credential exists. This guide compares DIA's Safety and Pharmacovigilance Certificate Program, university graduate certificates,…
Pharmacovigilance in Clinical Research: AE, SAE, and SUSAR Reporting
AE, SAE, SUSAR, and UPIRSO are not a simple hierarchy: an AE need not be a UPIRSO, and a UPIRSO need not be an AE at all. A decision table for what co…
Qatar Clinical Trial Approval Pathway: MOPH and the 2026 Executive Regulations
How clinical trial approval works in Qatar under Law No. 6 of 2025 on the regulation of health research and its 2026 executive regulations: the Minist…
RAC vs. CCRP Certification: Regulatory Affairs vs. Clinical Trial ConductComparison
RAC (RAPS) certifies regulatory affairs professionals across a product's full lifecycle; CCRP (SOCRA) certifies clinical trial conduct under GCP. A si…
Regulatory Intelligence: Building a Monitoring Function
A source taxonomy, monitoring mechanics, and a five-stage triage workflow for building a regulatory intelligence function that feeds submission strate…
Risk-Based Quality Management (RBQM) in Clinical Trials
How quality-by-design and ICH E6(R2)'s risk-based framework build quality into a clinical trial from protocol design onward, rather than relying on do…
SAHPRA: South Africa's Clinical Trial and Bioequivalence Study Authorization Process
SAHPRA authorizes South African clinical trials and bioequivalence studies under Section 21 of the Medicines Act. This guide covers the CTA process, t…
Sponsor Oversight of Delegated CRO Functions Under ICH E6(R3)
How ICH E6(R3)'s expanded sponsor-oversight framework applies when a sponsor delegates trial functions to a CRO: the Section 3.9 oversight requirement…
Target Trial Emulation: Applying RCT Design Principles to Real-World Data
What target trial emulation is, the seven-component Hernán & Robins protocol framework, the biases it addresses (immortal time bias, confounding by in…
The Biopharmaceutics Classification System (BCS): Classes and Biowaivers
How the Biopharmaceutics Classification System (BCS) classifies drugs by solubility and permeability into four classes, and when the resulting BCS-bas…
The NICE Technology Appraisal Process: How Evidence Becomes NHS Guidance
How NICE turns clinical and cost-effectiveness evidence into a binding NHS recommendation: STA vs MTA, evidence review groups, the appraisal committee…
Trapezoidal AUC: Linear vs Log-Linear Methods in Noncompartmental AnalysisComparison
A comparison of the linear and log-linear trapezoidal rules for calculating AUC in noncompartmental pharmacokinetic analysis, and how the linear-up/lo…
UK Clinical Trials Regulations: The 2026 Reform, Explained
A summary of the reformed UK clinical trials regulatory regime that took effect 28 April 2026 under SI 2025/538 -- risk-proportionate review, combined…

Laboratory Compliance & Quality

21 CFR Part 11 Compliance Checklist: A Clause-by-Clause Self-Assessment
An itemized 21 CFR Part 11 self-assessment checklist for a system you already run: what each clause (audit trails, e-signature binding, access control…
21 CFR Part 58: GLP Requirements for Nonclinical Studies
How 21 CFR Part 58 governs nonclinical safety studies: the study director's single-point authority, quality assurance unit independence, protocol and…
Calibration Certificates and Metrological Traceability: What "NIST-Traceable" Actually Means
What a compliant calibration certificate must contain, what metrological traceability (VIM) actually requires, why "NIST-traceable" is widely misused,…
Cleaning Validation: Worst-Case Grouping, MACO, and Acceptance Limits
A worked decision process for cleaning validation: worst-case product and equipment grouping, MACO calculation via dose-based, 10 ppm, and health-base…
Cleanroom Classifications: ISO 14644-1 and the FED-STD-209E Equivalents
The full ISO 14644-1 particle-limit table for ISO Class 1-9, the legacy FED-STD-209E Class 1/10/100/1,000/10,000/100,000 equivalents, and how a class…
Computer System Validation (CSV): GAMP 5, IQ/OQ/PQ, and 21 CFR Part 11
What computer system validation actually requires for regulated laboratory systems: the GAMP 5 risk-based approach, GAMP software categories and the c…
Current Good Manufacturing Practice: 21 CFR Guide
Current good manufacturing practice under 21 CFR 210/211: statutory rules, Phase 1 IND exemptions, and quality controls for research and clinical supp…
Document Control Procedure: The Six-Stage Lifecycle
How a document control procedure governs draft, review, approval, distribution, revision, and withdrawal for controlled documents in a GxP quality sys…
eCTD Module 3 Quality: A Section-by-Section Map of 3.2.S and 3.2.P
A section-by-section map of eCTD Module 3 quality: every 3.2.S drug-substance and 3.2.P drug-product subsection, what belongs in 3.2.A and 3.2.R, and…
EU Annex 11 vs. 21 CFR Part 11: Comparing Computerised-System RequirementsComparison
A clause-by-clause comparison of EU GMP Annex 11 and 21 CFR Part 11 on audit trails, e-signatures, risk management, suppliers, periodic evaluation, an…
EU Risk Management Plan (RMP): GVP Module V Structure and Requirements
What an EU Risk Management Plan (RMP) is under GVP Module V, when it's required, its Part I-VII structure, PRAC's review role, and how it differs from…
GMP for ATMPs: How EU Part IV Diverges from Standard Good Manufacturing Practice
How the EU GMP guidelines specific to Advanced Therapy Medicinal Products (EudraLex Volume 4, Part IV) diverge from standard GMP: a risk-based, propor…
GxP Compliance: What GLP, GCP, GMP, and GDP Actually Require
GxP is an umbrella term for GLP, GCP, GMP, GDP, and related "Good ... Practice" frameworks. This guide explains what they share, which one applies to…
ICH E6(R3) Annex 2: Remote Monitoring, Telehealth Visits, and Direct-to-Patient Shipment Oversight
A deep dive into ICH E6(R3) Annex 2's decentralised-trial provisions: remote and risk-based monitoring, telehealth-based visits, and sponsor oversight…
ICH E6(R3) Data Governance Requirements
How ICH E6(R3)'s Principles govern clinical trial data: the data lifecycle, quality-by-design applied to data, technology-agnostic (media-neutral) req…
ICH E6(R3) Definitions: Audit, Inspection, Monitoring and Quality Assurance
What ICH E6(R3) actually says an audit, an inspection, monitoring and quality assurance are — each definition quoted verbatim from the Step 4 Glossary…
ICH Q2(R2) Analytical Procedure Validation: Which Tests Apply, What Changed from Q2(R1), and How It Pairs with Q14
ICH Q2(R2) and ICH Q14 were adopted at Step 4 together on 1 November 2023. This guide sets out the Q2(R2) Table 1 test-selection matrix by measured qu…
ICSR Processing Workflow: Intake to Submission
The ICSR processing workflow end to end: intake channels, triage, duplicate detection, coding, causality assessment, medical review, QC, submission, a…
ISO 13485: Medical Device Quality Management Systems Explained
ISO 13485:2016 is the standalone international standard for medical-device quality management systems. A clause-by-clause walkthrough of what each req…
Laboratory Design for Compliance and Safety
A practical guide to the compliance and safety dimension of laboratory design: containment zoning, ventilation and pressure relationships, fume hood a…
Open vs. Closed Systems Under 21 CFR Part 11Comparison
The 21 CFR Part 11 open/closed system classification is decided by who controls access to record content, not by network topology — and getting it wro…
Process Performance Qualification (PPQ): Protocol Design, Sampling, and Acceptance Criteria
How Process Performance Qualification (PPQ) fits into the FDA three-stage process validation lifecycle, how it differs from equipment IQ/OQ/PQ, and ho…
Regulatory Affairs in the Pharmaceutical Industry
What the pharma regulatory affairs function actually does across the product lifecycle: strategy, FDA submissions, agency meetings, labeling, and post…
Signal Detection in Pharmacovigilance: A Practical Process Guide
A practical process guide to pharmacovigilance signal detection: disproportionality analysis (PRR, ROR, EBGM) with a worked PRR/ROR calculation from a…
Standardised MedDRA Queries (SMQs): Narrow vs. Broad Scope and When to Use Each
How SMQ narrow and broad scope differ, what algorithmic and hierarchical SMQs add, and how each is actually used in signal detection and aggregate saf…
Structured Product Labeling (SPL): Document Types, Data Elements, and the Validation Rules That Cause Rejection
A practical guide to authoring and submitting FDA Structured Product Labeling (SPL): the three registration and listing submissions, required data ele…
Type I, II and III Laboratory Water: Grades, Standards and Uses Compared
ASTM D1193, ISO 3696 and CLSI GP40 define laboratory water grades (Type I/II/III, Grade 1/2/3, CLRW) with overlapping but non-identical resistivity, T…
Validation Master Plan (VMP) for a Regulated Laboratory: Scope, System Inventory, and Periodic Review
A validation master plan is the governing document above individual qualification exercises. This guide applies EU GMP Annex 15 and Annex 11 to a regu…
What Is Good Laboratory Practice (GLP)?
A plain-language guide to Good Laboratory Practice (GLP): what it is, why FDA created it, what 21 CFR Part 58 requires, and how GLP differs from GMP a…

Grants Management & Research Funding

Accelerating Medicines Partnership Guide
The Accelerating Medicines Partnership (AMP) is a pre-competitive public-private venture between the NIH, FDA, industry, and non-profits managed by th…
CARB-X: Antibacterial Accelerator Program Guide
A guide to the CARB-X accelerator program, covering non-dilutive AMR funding rounds, eligible pathogen scopes, cost-share rules, and application phase…
FDA Clinical Hold: 21 CFR 312.42 Process Guide
A guide to FDA clinical holds under 21 CFR 312.42: complete vs partial holds, Phase 1-3 grounds, complete response requirements, and 30-day review clo…
FDA Drug Approval Process: CDER Regulatory Guide
A research-practice guide to the FDA drug approval process, from IND filing under 21 CFR 312 to NDA review by CDER under PDUFA review timelines.…
FDA NDA: New Drug Application Guide
A guide to the FDA New Drug Application (NDA) process under 21 CFR 314, covering eCTD modules, 505(b) pathways, review timelines, and filing requireme…
PhRMA Code: Ethical Standards & Compliance Guide
A compliance guide to the PhRMA Code on interactions with healthcare professionals, covering 2022 updates, speaker rules, OIG guidance, and annual aud…

Research Integrity & Compliance

Good Clinical Practice (GCP) Certification: What It Is, Who Needs It, and How to Get It
A practical guide to Good Clinical Practice (GCP) certification: what it is, who requires it, the real providers (CITI, ACRP, SOCRA), renewal cycles,…
Good Manufacturing Practice (GMP): A Guide for Research Institutions
What Good Manufacturing Practice (GMP) means, the regulations behind it (21 CFR 210/211, ICH Q7, QMSR), and why it matters for academic research, IND-…
Physician Payments Sunshine Act & CMS Open Payments: How It Works
A guide to the Physician Payments Sunshine Act (42 U.S.C. 1320a-7h) and the CMS Open Payments database: who must report, what counts as a reportable p…
Regulatory Affairs Certification (RAC): What It Is and How to Get It
RAC (Regulatory Affairs Certification) is RAPS's credential for pharmaceutical (RAC-Drugs) and medical-device (RAC-Devices) regulatory professionals —…
What Is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is the ICH E6 standard governing how clinical trials involving human participants are designed, conducted, and reported.…

Laboratory Equipment & Instrumentation

Biosafety Cabinet vs. Fume Hood vs. Laminar Flow Hood: Which Do You Need?Comparison
A biosafety cabinet protects worker, sample, and room. A chemical fume hood protects only the worker. A laminar flow hood protects only the sample. Th…
High-Resolution Mass Spectrometry: How Much Resolving Power and Mass Accuracy You Actually Need
Resolving power and mass accuracy specified by job rather than by datasheet: the resolving power needed to separate named isobaric pairs, how many can…
Mycoplasma Testing Methods Compared: PCR, Culture, Indicator Cell Culture and Luminescence
A method-selection guide to mycoplasma detection: direct culture, indicator cell culture with DNA staining, NAT/PCR and enzymatic luminescence compare…
SPE Cartridge Selection and Method Optimization: Sorbent Choice and the Wash-Step Trade-Off
A method-development guide to solid phase extraction: choosing a sorbent from analyte pKa and log D, the strong-versus-weak exchanger rule, and how to…

Scholarly Publishing

AdisInsight Guide: Drug & Clinical Trial Data
A comprehensive research guide to AdisInsight (Adis Insight), detailing its curated drug profiles, global clinical trial datasets, pharmacovigilance s…
BioMedTracker Guide: Pipeline & LOA Data
A comprehensive research guide to BioMedTracker, covering its database architecture, Likelihood of Approval methodology, search workflows, and biophar…
CHEERS 2022 Checklist: Reporting Economic Evaluations
What the CHEERS 2022 checklist requires when reporting a health economic evaluation, how it differs from CHEERS 2013, and how it relates to CONSORT, S…

Laboratory Operations & Safety

Choosing a Chemical Inventory Management System for Your Lab
A buying guide to chemical inventory management software: what it does, why spreadsheets fail at audit, the regulatory drivers, how it differs from a…
Lyophilization (Freeze-Drying): A Complete Process and Troubleshooting Guide
How lyophilization works: freezing, primary and secondary drying, the critical formulation temperatures that govern cycle design, troubleshooting cake…

Research Tools & Software

FDA Guidance Documents: Sponsor Search & Citation Guide
A sponsor guide to searching, interpreting, and citing FDA guidance documents under 21 CFR 10.115 Good Guidance Practices for clinical trials and regu…
What Is a LIMS? Laboratory Information Management System Explained
A Laboratory Information Management System (LIMS) tracks lab samples, workflows, and results with a full audit trail. This guide explains what a LIMS…

CRediT & Authorship

GPP 2022: Good Publication Practice for Company-Sponsored Medical Publications
GPP 2022 is the current industry standard governing authorship, transparency, data access, and publication planning for company-sponsored biomedical r…

Research Data Management

Electronic Lab Notebook Validation Under 21 CFR Part 11 and GxP
A practical guide to validating an electronic lab notebook (ELN) for regulated GxP research: 21 CFR Part 11 requirements, the IQ/OQ/PQ computer system…

Research Methods & Statistics

IND vs NDA: Regulatory ComparisonComparison
A regulatory comparison of FDA Investigational New Drug (IND) and New Drug Application (NDA) submissions, detailing 21 CFR rules, review clocks, and r…

Technology Transfer & Innovation

FDA ANDA Application: The Generic-Drug Approval Pathway Explained
An ANDA (Abbreviated New Drug Application) is FDA's pathway for approving generic drugs based on bioequivalence to a reference product, not new clinic…

Key terms

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